The right people. The right solution. The first time.

Transcription

1 The right people. The right solution. The first time. Educational Program Europe January December 2015

2 Why train with us? The right people. The right solution. The first time. 2 Flexible, Professional and Career- Pathway Driven Education from the Best in the Industry From Webinars to Professional Certification 1 hour webinars or 5 day intensive modular programs, we aim to ensure that the right education is delivered using internationally renowned specialists. Many training providers focus upon what the requirements are and their impact; NSF, on the other hand, focuses on how to address the requirements and apply them in the most effective way within your business. Our Courses Drive Career Development and Lead to Post-Graduate Qualification If you study with NSF, no matter how long the course duration, we have ensured that the knowledge we provide forms part of an overall professional recognition and career development framework regardless of your location. For those with EU regulatory compliance responsibility, our courses are set to meet the requirements of a Medical Device Qualified Person. Our Course Content We are public health and safety experts, with roots firmly fixed in the world of quality assurance, regulatory science and regulatory affairs associated with healthcare technologies and medicines. With that in mind we have developed a world-leading series of training and education services aimed specifically towards ensuring that professionals and companies alike can achieve confidence in their ability to act in the best interests of the patient, clinician, manufacturer and regulatory agency. What our customers have said about our courses... Great course challenging with nowhere to hide in the background, plenty of chances to ask general questions. Peter Iddon, Neotherix This course has perfectly provided the learning needed for current projects at work. Wolfgang Angerman, Stryker Great to have such an applicable course put on locally, excellent expert panel. Sarah Carpenter, Smith & Nephew The day was excellent. The technical content and relevance was very good. Simon Redfern, Smiths Medical Our In Company Services All of our In Company courses drive career development and lead to formal qualification. We can bring any of our courses to you, either at your premises or at a venue local to you. You can decide whether you would like the off the peg courses or bespoke versions adapted to your particular products and company profile. Recently provided in-company training programs include: CE marking of Telehealth / ehealth applications Design Control for auto-injectors and other combination products Understanding the clinical requirements for Class III cardiovascular implants in EU clinical study sites Planning biocompatibility testing strategies for global regulatory submission In Company Delivery Our qualified tutors work with your company to outline exactly the types of regulatory compliance programs you would like to implement within your company. From simple ½ day briefings to full 5 day modular delivery, we are able to plan the training and education experience you require to address regulatory risks, enhance expertize and achieve career development for your people. With further elective modules you can develop specific areas of expertize in In-Vitro Diagnostics, Clinical Data, Process Validation, Biological Evaluation or Auditing. Executive Briefings For people planning the future of the company and its products you need training and education to concentrate upon strategy, project planning, risk and budgets. Our executive briefings do exactly that; from courses outlining drug / device combination products to determining global market entry for high risk IVDs, our series of briefings will enable you to gain confidence in your strategic decisions. Ideal for: CEOs Leadership teams Investment bankers Business development personnel Team Leader Briefings People who are actively doing the job and leading the team need to quickly understand why they are doing something so that they can quickly motivate, coach, support and lead their teams towards regulatory compliance. Our Team Leader briefings are fast-paced, example-driven practical courses aimed at keeping the balance of theory with reality in order to ensure the correct messages are issued. From regulatory overviews to examining cases of where poor awareness has affected regulatory compliance, our team briefings are specifically aimed at large audiences in short sessions delivered by facilitators who keep the audience engaged and energized. Workforce Briefings External professionals explaining why it is important to maintain compliance to an entire workforce can sound rather academic; however it is critically important for medical technology organizations to ensure that their workforce understand that they are involved in some of the most important products in our lifetime. We have specialized large class developed lectures aimed towards engaging a general workforce and stimulating their thoughts and behaviors towards regulatory compliance. Our lectures focus on the human whys rather than regulatory requirements, outlining the duty of care every employee has in ensuring that they make the right decisions that achieve a safe and effective product. For more information about how NSF courses could come to your business, [email protected] or visit our website at 3

3 About our Education The right people. The right solution. The first time. We Are Different but in a Good Way When you choose a course what do you really look for? Content Gain knowledge to apply Recognition of competence Career progression We have invested heavily in ensuring that all of our courses are relevant to the needs of the industry. We explain the how rather than the what which enables you to get on and plan, implement and succeed in your project activities. All knowledge we provide forms part of an overall professional recognition and career development framework regardless of your location. Full steam ahead or in your stride, study at the pace you or your company demands. With plug and play courses, modules and university registration your career and education pathway is in your hands. Post Graduate Certificates Our Post Graduate certificates enable you to study the specific elements that impact the quality of your decision making to reduce your risk and achieve regulatory compliance. With modules focused upon Software Quality, Design, Clinical, Quality Systems and Post Market Surveillance you can plan your quality and regulatory career by specific topic and subject. Routes available are: PgCert Medical Device QARA Design Route PgCert Medical Device QARA Clinical Route PgCert Medical Device QARA Quality Assurance Route PgCert Medical Device QARA Regulatory Route Module Certificates Module certificates demonstrate a professional achievement in discrete areas of regulatory compliance. Our module certificates enable people working in Product Safety, Design, Clinical, Quality Engineering and Auditing functions to demonstrate that they have achieved a fundamental knowledge of the critical subjects involved in ensuring a safe and effective medical device. Module Certificates we provide are: Module 1: CE & Global Regulatory Professional Module 2: Design, Risk and Safety Standards Module 3: CE & Global Clinical Requirements Module : Pre & Post Market Technical File Data Module 5: Global Quality System Requirements Module 6: CE Post Market & Vigilance Module 7: Working with Regulatory Agencies Module 8: The Professional Qualified Person Module 9: Biological Evaluation and Test Methods Module : Sterile Requirements Module 11: Medical Device Auditing Professional Module 12: Supplier Quality Professional Module 13: Process Validation Professional Module 1: Software Regulatory & Quality Module 15: IVD Regulations, Quality & Product Safety Module 16: Combination Product Requirements Module 17: US Medical Device Regulations Professional Certificates If you are not ready to enter into formal university study but you want to ensure you understand the theories and practices to achieve regulatory compliance in Design, Supply or Post Market of medical technologies then our professional certificates are an ideal qualification to meet the knowledge requirements of a modern day medical device regulatory compliance professional. With progression to Chartered Quality Professional status and recognition from allied professional institutions our professional certificates enable you to study the requirements but manage your time without the added burden of university study. Professional certificates meet the education and training requirements of the PgCerts and PgDip but do not include the rigorous academic assessment. For people who do not have the necessary time for academic study or are already qualified at relevant degree level. Professional Certificate Medical Device QARA Design Professional Certificate Medical Device QARA Regulatory Professional Certificate Medical Device QARA Regulatory Sciences Professional Certificate Medical Device QARA Medical Device Auditor Professional Certificate Medical Device QARA Medical Device Quality Assurance Drivers to Your Education Knowledge & Competence Less time More focused on ability to do the job Professional recognition Academic Recognition Academic Research driven Thought leading Address the University Diploma requirement in the EU regulation Courses Modules Module Assessment Critical Evaluation University Enrollment Professional Recognition University Accreditation Graduation Ceremony Work-Based Assignments Academic Assessment Association with Sheffield Hallam University NSF Health Sciences has a highly successful track record for delivering quality training to both the medical device and pharmaceutical industries. We have implemented the first state of the art Medical Device Qualified Person (QP) program in collaboration with Sheffield Hallam University. All tutors are recognized subject matter experts. The QA/RA environment is becoming increasingly complex. Recent EU legislation is advocating that industry has qualified QA/RA professionals in strategic roles. With this in mind NSF Health Sciences has developed a unique modular training program that will enhance the existing credentials of QA/RA professionals. The QP program offers several training options provided at dedicated learning centres or, in-house. Certificate: Successful completion of modules. Suitable for those professionals wanting to bridge certain skill gaps. Or for those who simply want to test the water before aiming high and studying for a Diploma or MSc. Complete in 1-2 years. Diploma: Successful completion of all 8 modules. Completion of the University diploma results in practitioner grade membership of the Chartered Quality Institute. Complete in 2- years. An MSc: Completion of the Diploma opens the door to a QA/RA MSc with Sheffield Hallam University. The course requires completion of a relevant project selected by the student and sanctioned by the University. 5 For more information about NSF courses, [email protected] or visit our website at

4 Our Training Courses by Module Module 1: CE & Global Regulatory Professional Module 5: Global Quality System Requirements Module 9: Biological Evaluation and Test Methods Module 1: Software Regulatory & Quality Regulatory Horizon page 9 CE Marking Requirements for Complex Borderline and Class III page 11 CE Marking Requirements for Implementing page 11 CE Marking Requirements for Understanding and Preparing for the New EU Regulation page 12 Module 2: Design, Risk and Safety Standards Implementing Design Control for page 17 Planning for Content Deviations in ISO 1971:2012 page 2 Risk Management for Software Based page 28 Understanding Design Control for page 32 Understanding Risk Management ISO 1971 for page 32 Understanding Standards for CE Marking of page 33 Module 3: CE & Global Clinical Requirements Clinical Evaluation Step by Step page 23 Planning and Conducting Clinical Investigations for page 23 Post Market Clinical Follow Up for page 25 Module : Pre & Post Market Technical File Data CE Marking Preparing and Managing Technical Documentation page The Design History File for page Compliance Horizon page 8 Implementing ISO 1385 A Project Management Approach page 18 Introduction to ISO 1385 page 19 ISO 1385 Advanced Effective Change Control page 20 ISO 1385 Advanced Effective CAPA Investigations page 20 Module 6: CE Post Market & Vigilance Field Safety and Recalls for CE Marked page 15 Post Market Surveillance Plans for CE Marked page 25 Product Surveillance and Vigilance for CE Marking of page 27 Module 7: Working with Regulatory Agencies Pre Market Technical Briefings for page 26 Regulatory Agency Enforcement & Remediation for page 28 Structure of the Regulatory Agencies for page 29 Module 8: The Professional Qualified Person Communicating Quality and Regulatory Strategy to Senior Leaders and Investors for Medical Device CE Marking page 13 Project Management for A Case Study Approach page 27 The Anticipated Role of the New Qualified Person for Medical Device CE Marking page Product Safety Horizon page 8 EN ISO 993: Biological Evaluation of page 15 Study Day Biological Evaluation and Product Safety for Complex Medical Technologies page 30 Undertaking Biological Evaluation for CE Marking Step by Step page 35 Module : Sterile Requirements Implementing the Requirements for Sterile page 19 Sterilization Process Requirements for page 29 Understanding the Requirements for Sterile page 3 Module 11: Medical Device Auditing Professional How to Audit Series Advanced Audit Techniques Notified Body Auditing Techniques page 16 How to Audit Series How to Audit Combination Products page 16 How to Audit Series Advanced Auditing techniques page 17 Module 12: Supplier Quality Professional Implementing Supplier Control for Medical Devices CE Marking page 18 Understanding Supplier Control for Medical Devices CE Marking page 33 Module 13: Process Validation Professional Process Validation for Planning and Conducting page 26 CE Marking for Medical Device Software Technical File and Quality System Requirements page 9 CE Marking Medical Device Software Regulatory Requirements Step by Step page Clinical Evaluation of Medical Device Software for CE Marking page 12 Current Approaches to CE Marking Software (ehealth, Apps and Stand-Alone) page 1 Module 15: IVD Regulations, Quality & Product Safety IVD CE Marking Regulatory Requirements Step by Step page 21 IVD CE Marking Standards, CTS and Performance Evaluation page 21 IVD CE Marking Technical File Compilation & Management page 22 IVD Clinical Data and Post Market Surveillance Plans page 22 Planning for the Revision of the IVD Directive 98/79/EEC page 2 Module 16: Combination Product Requirements Combination Product Risk Management and Biological Evaluation Key Issues page 13 Design Control for Combination Products page 1 Understanding Combination Product Regulations page 31 Understanding the Safety and Usefulness of a Medicinal Substance for a Medical Device page 3 Module 17: US Medical Device Regulations US Medical Device Regulations and Quality System Compliance Series page 35 7 For more detailed information about our Medical Device Modules, [email protected] or visit

5 2 days Module 5: Global Quality System Requirements Module 9: Biological Evaluation and Test Methods Module 1: CE & Global Regulatory Professional Module 1: Software Regulatory & Quality Compliance Horizon This will be a review of the EU notified body and FDA warning letters issued in 201. We will explain the critical focus required to address these issues with your quality systems compliance plans. If you are involved in quality systems and compliance and are working upon the development of your companies quality plan for 2015 you will find this course highly beneficial. Learning lessons from last year will enable you to put into the place the improvements needed to maintain a regulatory compliant quality system. 21st January 2015 Sheffield/Webinar 2015 Product Safety Horizon A review of new risks new standards and new requirements impacting medical technology product safety in 201. The course will provide specific risk management and product safety strategy required for an array of medical device technologies. This course is essential for any professionals responsible for product safety within medical devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill. 22nd January 2015 Sheffield/Webinar 2015 Regulatory Horizon This will be a review of the issues surrounding the regulations globally that could affect medical devices. Certainly the European Medical Device and IVD regulations are being progressed well and therefore we will provide the necessary update so that people can plan within For commercial, regulatory and quality professionals wishing to understand the impact of the medical device regulatory requirements primarily in Europe relating to medical devices and in-vitro medical devices. Professionals allied to the medical device industry such as legal and development consultants may find this overview extremely beneficial. 20th January 2015 Sheffield/Webinar I felt the NSF Tutor delivered the course excellently. My knowledge base was relatively zero entering the course and I feel all subjects were explained brilliantly. Darren Hall, Swann Morton CE Marking for Medical Device Software Technical File and Quality System Requirements Two day course taking you through the specific expectations of software as a medical device including the technical file elements, validation methods and harmonized standards you will need to understand in order to demonstrate that your software fulfills the essential requirements in Europe. This course addresses the design control requirements often referred to as the software development lifecycle, as well as the quality management system specifics that most people unfamiliar with software quality assurance will need to know. The course explains the what in terms of regulatory and quality system requirements and works hard on the how by leaving you with simple project plans, checklists and draft procedures that you can adapt for your business. A truly practical how to course. This course is also available in-house and recommended for: Medical Device Product Managers Medical Device Product Designers Medical Device Product Testers Medical Device Software Product Developers Medical Device Quality Managers Medical Device Quality Engineers Medical Device Regulatory Personnel Robert Cutts-Watson 9 11th-12th February th-15th July 2015

6 3 days 2 days Module 1: Software Regulatory & Quality Module : Pre & Post Market Technical File Data Module 1: CE & Global Regulatory Professional Module 1: CE & Global Regulatory Professional CE Marking Medical Device Software Regulatory Requirements Step by Step One day course for people who need to understand the regulatory requirements for software as a medical device. This course will help you to determine how to effectively understand whether software is subjected to CE marking requirements. This is a practical case study driven training course which leaves you with no doubt as to how to approach explaining the commercialization risks associated with your software. Moreover, the day consists of project planning sessions necessary to determine the pathway to conformity with CE requirements. This course is also available in-house and recommended for: Medical Device Product Managers Medical Device Product Designers Medical Device Product Testers Medical Device Software Product Developers Medical Device Quality Managers Medical Device Quality Engineers Medical Device Regulatory Personnel Robert Cutts-Watson 9th February th July 2015 CE Marking Preparing and Managing Technical Documentation A three day course aimed towards quality, regulatory and product safety personnel involved in the pre-clinical, clinical, regulatory submission, onmarket management and post market surveillance of medical devices. The course is biased towards European CE marking requirements for technical documentation but provides essential tips for the successful compilation of technical information such as scientific briefing documents, presubmission regulatory strategy and product safety summaries as well as the common expectations necessary for an EU technical file and Summary Technical Evaluation Document. If you need to generate a technical file for CE marking or global submissions then this is the course for you! Aimed at those who are involved in managing the submission of documentation to competent authorities, notified bodies and other interested agencies. Design, quality and regulatory professionals will benefit specifically from the best practices associated with the generation and management of technical documentation for pre-clinical, clinical investigation, submission and post-market development of technical data. th-6th February 2015 CE Marking Requirements for Complex Borderline and Class III Medical Devices Class III and borderline medical devices falling under the medical devices CE marking regulatory requirements require a knowledge of a higher level of interaction with the notified body, competent authorities and other regulatory agency expert groups. From preclinical, clinical and regulatory specifics associated with Class III products we enable you to understand the specific regulatory hurdles that you need to clear prior to successful CE registration. Specifically aimed towards quality and regulatory professionals responsible for the formulation of regulatory strategy and ensuring regulatory compliance of medical devices within Europe. For pharmaceutical QPs wishing to understand the regulatory requirements for medical devices including combination products. CEOs and CTOs of new start-up business will find the modular and flexible delivery of this program of particular interest when formulating a regulatory project plan for their commercialization process. Jonathan Hughes David Shea 21st May th September 2015 CE Marking Requirements for Implementing A two day implementing course that will allow you to project manage the necessary processes, documentation and registration requirements for a CE marked medical device. Building upon the one day understanding course you will move into establishing the project management steps, milestones, procedures and regulatory interactions necessary to successfully coordinate a CE marking project. Specifically aimed towards quality and regulatory professionals responsible for the formulation of regulatory strategy and ensuring regulatory compliance of medical devices within Europe. For pharmaceutical QPs wishing to understand the regulatory requirements for medical devices including combination products. CEOs and CTOs of new start-up business will find the modular and flexible delivery of this program of particular interest when formulating a regulatory project plan for their commercialization process. Jonathan Hughes David Shea 19th-20th May nd-23rd September The NSF Tutor really knows his stuff, enjoyed working through MDD Found it really helpful. Wilson Kennedy, Hospira

7 2 days Module 1: CE & Global Regulatory Professional Module 1: Software Regulatory & Quality Module 16: Combination Product Requirements Module 8: The Professional Qualified Person 12 CE Marking Requirements for Understanding and Preparing for the New EU Regulation The regulatory requirements for medical devices are being revised under a new European medical device regulation. As many decisions are still to be taken this course aims to ensure that you are aware of the most robust and likely requirements to be implemented that have an impact upon your regulatory compliance and future regulatory strategy. Specifically aimed towards quality and regulatory professionals responsible for the formulation of regulatory strategy and ensuring regulatory compliance of medical devices within Europe. For pharmaceutical QPs wishing to understand the regulatory requirements for medical devices including combination products. CEOs and CTOs of new start-up business will find the modular and flexible delivery of this program of particular interest when formulating a regulatory project plan for their commercialization process. Jonathan Hughes David Shea 18th May st September 2015 Clinical Evaluation of Medical Device Software for CE Marking One day course discussing the approaches required to obtain data demonstrating clinical efficacy and clinical benefit over risk in the area of clinical data. The course takes you through clinical investigation strategies, clinical evaluation methods and post market clinical follow-up specific to software based medical devices, in particular stand alone software. This course is also available in-house and recommended for: Medical Device Product Managers Medical Device Product Designers Medical Device Product Testers Medical Device Software Product Developers Medical Device Quality Managers Medical Device Quality Engineers Medical Device Regulatory Personnel Robert Cutts-Watson 16th July 2015 Combination Product Risk Management and Biological Evaluation Key Issues A two day product safety course outlining the specific risks and expected controls for combination products. If you are involved in combination products, i.e. drug / device combinations, then you will be expected to demonstrate that you have taken into account the risks associated when the two entities combine. We explore typical aspects such as biocompatibility, drug efficacy, extractables and leachables as well as the subsequent expert opinion on expected controls. By the end of the course you should be able to prepare risk management documentation that is in line with regulatory agency expectations. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course. 28th-29th April th-17th September 2015 /Webinar /Webinar Communicating Quality and Regulatory Strategy to Senior Leaders and Investors for Medical Device CE Marking A one day course that addresses the techniques to adopt when speaking to senior leaders, investors and other non-technical interested parties about regulatory and compliance strategies. The course takes you through the current problem with communicating information to leadership teams and investors and enables you to adapt your messaging, presentation style, promises and handling expectations. We take you through how to handle the difficult situation of explaining why a product will not be available in Europe in Q3! by providing you with the necessary plans, decisions and tools necessary to ensure leadership understand the complexity and new pressures that exist within the European Medical Device regulatory framework. The module is aimed at quality and regulatory professionals wishing to build upon their technical skills and move into formal career development by discussing project management, management and presentation behaviors. 2th June

8 2 days Module 1: Software Regulatory & Quality Module 16: Combination Product Requirements Module 9: Biological Evaluation and Test Methods Module 6: CE Post Market & Vigilance 1 Current Approaches to CE Marking Software (ehealth, Apps and Stand-Alone) A study day that brings together the leading regulatory, technical and product safety specialists in the field of software medical devices to discuss the specific trends associated with the CE marking of software. The study day addresses borderline issues such as ehealth and mobile health, discusses software applications and the regulatory options in Europe and brings together leading software quality engineering and cyber security experts to discuss the ongoing challenges of having a device that if hacked can potentially kill. The study day is a panel of experts brought together in an interactive learning environment whereupon you are afforded the opportunity to question, challenge and collaborate with the best in the business. Not to be missed! This course is also available in house and recommended for: Medical Device Product Managers Medical Device Product Designers Medical Device Product Testers Medical Device Software Product Developers Medical Device Quality Managers Medical Device Quality Engineers Medical Device Regulatory Personnel Robert Cutts-Watson th February 2015 Design Control for Combination Products One day course for quality and regulatory compliance professionals involved in the management of the design of medical devices. This course will enable the delegate to understand the requirements for Design History (particularly from the US FDA CFR21 Part ) and how to structure an effective DHF. Practical examples are based specifically around combination products, bearing in mind the recent introduction of CFR21 Part Combination product regulations. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course. Beat Steffan 6th February 2015 EN ISO 993: Biological Evaluation of A one day course aimed towards the requirements for biological evaluation of medical devices. The course identifies the essential principles of safety and performance around biocompatibility and provides you with the necessary science to understand the fundamentals of bioactivity. Upon the review of biocompatibility requirements we then introduce you to the ISO 993 series of standards, enabling you to understand exactly what they are and when to apply them. This course is essential for any professionals responsible for product safety within medical devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill. Alastair Selby 11th May nd November 2015 Field Safety and Recalls for CE Marked A two day intensive course providing you with the tools necessary to effectively manage the critical aspects of field safety notifications, field safety updates and the specific requirements for withdrawing product from within Europe. Providing simulations and scenarios the tutors will take you through the decision making processes, plans, risks and considerations to be made in order to manage patient safety, regulatory action and protect company reputation. Starting with the basic requirements and common methods and then moving into communication strategies, distribution considerations and supply-chain coordination, this course will enable you to manage some of the most complicated and stressful decisions you may experience in the marketplace. Forewarned is forearmed and this course will enable you to make realistic and valuable updates to your field safety and product recall processes. Aimed at all professionals managing a medical device placed on the market and involved in any post market surveillance and vigilance, QMS feedback, clinical follow up and vigilance decision making activities. Authorized representatives and distributors will also find this module highly applicable to their function as critical operators within the supply and post market support of medical devices. Jonathan Hughes 21st-22nd April 2015 London 15

9 2 days Module 11: Medical Device Auditing Professional Module 11: Medical Device Auditing Professional Module 11: Medical Device Auditing Professional Module 2: Design, Risk and Safety Standards 16 How to Audit Series Advanced Audit Techniques Notified Body Auditing Techniques Notified body (NB) audits are under intense scrutiny from the European commission ever since the PIP incident. As a result we have prepared a course that enables you to understand the mindset of the notified body auditor, provides you with the tools and techniques adopted by notified body auditors so that you can adequately prepare your organization and for many act and simulate the notified body audit. We take you through the specific elements that NB auditors have been asked to concentrate upon during unannounced audits and enable you to pick up the tricks of the trade in order to effectively audit like an NB. Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course. Henry Sibun 7th May th November 2015 How to Audit Series Medical Devices How to Audit Combination Products This course is particularly biased towards medical device manufacturers that now face the likelihood of a GMP (pharma) based inspection or audit. The course is aimed to address the cross over between medical device and medicinal product regulations and enables traditional medical device auditors to understand the specific requirements for the active ingredient or specialist material that may be subjected to non-medical device regulation. From controls of raw materials, environmental and GMP expectations to the release of a combination product this course will certainly enable you to undertake audits in a way you would not have covered as a general medical device auditor. Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course. Henry Sibun 8th May th November 2015 How to Audit Series Medical Devices Advanced Auditing Techniques Auditing is a skill that requires fundamental knowledge and practice. This course takes you through the specific requirements for auditing as defined in ISO and, as it is medical device specific, identifies the specific behaviors, skills and audit planning necessary to be a successful medical device auditor. The course will provide you with an overview of FDA investigator training and EU notified body auditor training, as well as enable you to learn effective ways of quickly identifying non-compliance through active mentoring from some of Europe s most experienced notified body auditors. We examine audit planning, conduct and non-compliance identification but concentrate upon audit trails, sampling and nonconformity identification. The course uses examples of medical device processes throughout, enabling you to address your internal auditor training needs. Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course. Henry Sibun 5th-6th May th-th November 2015 Implementing Design Control for From a recent review of FDA warning letters, EU notified body assessments and the specific introduction of combination product regulations, it is clear that the concepts and techniques used in design control and risk management are still unclear to manufacturers wishing to implement, improve and maintain their development processes. From understanding the requirements for combination product design and development processes subjected to CFR21 Part and the typical requirements defined in CFR21 Part , ISO 1385 and the European Directives, the implementation course now goes through the specific changes you need to make to your Design plans, Design Input, Output and Design History documentation as well as your development processes and procedures in order to successfully implement compliant and effective design control. Development, regulatory and quality professionals responsible for design control and design transfer of medical devices. This course demonstrates your expertize to coordinate, plan and control the necessary elements of design quality to produce a safe and effective medical device. Pharmaceutical quality professionals responsible for development of combination products will benefit from completing this course as it covers all aspects of the design control and design transfer requirements within CFR21 Part. Duncan Keeble Marcus Orton 17 1th April th October 2015

10 2 days 2 days 2 days Module 5: Global Quality System Requirements Module 12: Supplier Quality Professional Module : Sterile Requirements Module 5: Global Quality System Requirements 18 Implementing ISO 1385 A Project Management Approach A two day course identifying how to implement ISO 1385 from quality system documentation through to establishing the necessary procedures, records, reviews and processes. We outline the most effective way of implementing ISO 1385 and detail exactly how to project manage an implementation process that will be inspection ready. Full of practical examples, procedures, project plans and simple checklists, this course will enable you to implement the necessary requirements without the need for consultants! Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 1385 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS. Henry Sibun 17th-18th March th-7th October 2015 Implementing Supplier Control for CE Marking This two day course has been developed to build upon the Understanding course and enable you to develop appropriate purchasing requirements, supplier evaluation and selection methods necessary to demonstrate effective control over the supply chain. Concentrating upon the establishment of quality and technical agreements, the course outlines the importance of supplier evaluation and re-evaluation and provides a solid basis for establishing robust procedures in the field of supplier control. If you are working with critical suppliers and subcontractors this course is one of a kind in that it provides you with the necessary requirements for how to suitably select, specify, qualify and monitor the supply chain. If you are a virtual manufacturer you will find this course particularly useful. 21st-22nd July 2015 Implementing the Requirements for Sterile Two day course specifically looking at sterile medical devices, moving on from the basic requirements towards how to design appropriate environmental controls, cleanrooms, cleaning, packaging and sterilization processes necessary to achieve a sterility assurance level. The course examines the numerous harmonized standards and regulatory compliance expectations that you will need to address within your technical file, environmental monitoring program and quality management system. There are plenty of hints, tips, project plans and checklists to be able to navigate the maze of regulatory requirements concerning this area. The course is designed for development engineers, manufacturing engineers, validation engineers, quality assurance and regulatory personnel involved in the design, validation and routine control of processes used during the manufacture of sterile medical devices. Simon Richards Henry Sibun 3rd-th March 2015 Introduction to ISO 1385 Whether you are working toward the registration of your first CE marked product or you are wanting to diversify into the medical device supply chain, ISO 1385 is the standard required for all regulatory aspects associated with your processes. This course takes you through how to plan and execute an implementation project, enabling you to walk away understanding exactly what needs to be done and how to successfully implement ISO 1385 within your organization. Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 1385 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS. Henry Sibun 16th March th October Very informative course, the discussion on auditing approach effectiveness US compliance very good Gareth Quinn, Baxter

11 Module 5: Global Quality System Requirements Module 5: Global Quality System Requirements Module 15: IVD Regulations, Quality & Product Safety Module 15: IVD Regulations, Quality & Product Safety ISO 1385 Advanced Effective Change Control ISO 1385 Advanced Effective CAPA Investigations IVD CE Marking Regulatory Requirements Step by Step IVD CE Marking Standards, CTS and Performance Evaluation 20 The largest risk to your medical device product safety is the constant change that your organization has to make! This course outlines the requirements for change control and provides a critical insight into how to manage change control, from basic design control through to changes within personnel. Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 1385 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS. Henry Sibun 19th March th October 2015 In order to undertake corrective and preventive action effectively there is a need to understand exactly what constitutes good practice. This course is aimed towards helping you to identify CAPA opportunities and takes you through how to effectively investigate using the information and tools available within your organization. As a medical device manufacturer it is critical that CAPA is effective and it is a common expectation by regulatory agencies that this is one of the most robust processes within your organization. Learn how to manage CAPA effectively, from identifying and managing sources of CAPA to the effective implementation of corrective actions. Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 1385 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS. Henry Sibun One day course aimed towards ensuring that those personnel bringing a IVDD into the market (Europe) are aware of the requirements. The course also enables regulatory and quality personnel to plan the impact of the new directive scheduled to come into force in Q Senior management Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel Organizations preparing own brand or private label devices Distributors of IVDs Sarah Couch 28th January th March th October 2015 One day course outlining diagnostic utility and performance evaluation for IVDs. The course aims to bring you up to speed with the latest product safety activities required by the IVD Directive to address essential safety and performance requirements. Senior management Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel Organizations preparing own brand or private label devices Distributors of IVDs Sarah Couch 30th January th March th March th October 2015

12 2 days Module 15: IVD Regulations, Quality & Product Safety Module 15: IVD Regulations, Quality & Product Safety Module 3: CE & Global Clinical Requirements Module 3: CE & Global Clinical Requirements 22 IVD CE Marking Technical File Compilation & Management One of the major aspects of CE marking for IVDs is the compilation and management of appropriate technical documentation. This course takes you through the requirements for IVD technical files, outlines common technical specification, harmonized standards and the best practices adopted for maintaining appropriate compliant technical files. Senior management Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel Organizations preparing own brand or private label devices Distributors of IVDs Sarah Couch 29th January th March st October 2015 IVD Clinical Data and Post Market Surveillance Plans With changes to IVD regulation in Europe it will become more evident that IVD manufacturers will need to have robust PMS and clinical data. The methods of planning, conducting and documenting clinical data for IVDs are certainly different to general medical technologies; hence this course takes you through the best practices within this area. Full of examples, plans and solutions you will find this course of value if you are preparing for the changes. Senior management Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel Organizations preparing own brand or private label devices Distributors of IVDs Sarah Couch 22nd October 2015 Clinical Evaluation Step by Step Learn how to undertake a critical review of scientific and clinical data in order to present a robust clinical evaluation of your device technology s clinical performance. This course will enable you to understand the disciplined approach required to meet the requirements for clinical evaluation defined within 93/2/EEC Annex X and identify when clinical data is sufficient and not sufficient to support your medical device. Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy. Rikke Arendt Christiansen Alastair Selby th-11th February th-15th July th-25th November 2015 Planning and Conducting Clinical Investigations for From establishing what should be within the clinical study protocol to understanding the actual stages for applying for Clinical Investigation with European Competent authorities, this course will enable you to understand the decision making and practical aspects concerning EU Clinical Investigations. Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy. Rikke Arendt Christiansen Alastair Selby 9th February th July rd November

13 2 days 2 days Module 2: Design, Risk and Safety Standards Module 15: IVD Regulations, Quality & Product Safety Module 3: CE & Global Clinical Requirements Module 6: CE Post Market & Vigilance Planning for Content Deviations in ISO 1971:2012 Planning for the Revision of the IVD Directive 98/79/EEC Post Market Clinical Follow Up for Post Market Surveillance Plans for CE Marked 2 A one day course specifically dedicated towards managing the additional focus from notified bodies and EU regulatory agencies associated to the content deviations within ISO We discuss the background to the deviation and identify the specific elements in your risk management documentation that need to be reviewed and addressed in order not to fall foul of the content deviations. A practical and informative course that will enable you to review your current approach to risk management and compare it with the expectations of your notified body. Development, regulatory, quality and product safety professionals responsible for the coordination of risk management activities. Duncan Keeble Marcus Orton 22nd October 2015 A one day course aimed towards enabling people involved in IVD regulatory to understand the impact of the regulation and ensure an appropriate plan is in place to address the new requirements in This course will be particularly appealing to those personnel responsible for the commercial planning of products set to fall under the new IVD Directive. Senior management Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel Organizations preparing own brand or private label devices Distributors of IVDs Sarah Couch 27th January rd March th October 2015 Within the European medical device directives there are specific requirements for obtaining post-market data relating to the clinical performance of your product utilizing a post market clinical follow-up plan. This course presents the requirements for PMCF and will enable you to understand the requirements and apply them to your internal procedures. Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy. Rikke Arendt Christiansen Alastair Selby 12th-13th February th-17th July th-27th November 2015 Unless you have been in a land far-far away you will be aware of the additional scrutiny of CE marked products and in particular the methods of adopting appropriate product surveillance plans and subsequent data analysis in order to provide early warning of product safety and quality issues. This course takes you through the notified body and competent authority expectations for post market surveillance and applies a case study approach for a series of different types of devices including the obvious implantable products but also covering woundcare, infusion pumps, electro-medical diagnostic devices and single use instruments. Moving from the basic regulatory requirements to establishing best in class trending data from internal and external sources, we will equip you with the necessary insight towards adopting a fit-for-purpose post market surveillance plan and introduce you to the necessary quality management system procedures, data collection methods and state-of-the-art methods to maintain a robust, cost-effective and highly informative analysis that will inform your regulatory compliance. Aimed at all professionals managing a medical device placed on the market and involved in any post market surveillance and vigilance, QMS feedback, clinical follow up and vigilance decision making activities. Authorized representatives and distributors will also find this module highly applicable to their function as critical operators within the supply and post market support of medical devices. 25 Jonathan Hughes 23rd-2th April 2015 London

14 2 days 3 days Module 7: Working with Regulatory Agencies Module 13: Process Validation Professional Module 6: CE Post Market & Vigilance Module 8: The Professional Qualified Person 26 Pre Market Technical Briefings for A two day course aimed towards medical device manufacturers or manufacturers unsure of the appropriate regulatory classification. This course has been developed in order to help you understand the regulatory agencies involved in formulating a medical device classification when it is extremely complex, novel or has borderline properties. The course helps you to prepare technical information in a way that can be presented to regulatory agencies so that you can achieve definitive responses as to the classification, conformity assessment route and need for pre-clinical and clinical data. The course begins by describing the importance of the product description, intended use and principal mode of action. From determining who to contact in what agency through to simple tips for managing the briefing, you will find this course invaluable if you wish to carve out a career in advanced regulatory, quality or product safety in healthcare technology products. The course is aimed at personnel within the organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement. Process Validation for Medical Devices Planning and Conducting A highly interactive course. The first day starts you off with the requirements for process validation and looks at various guidance from the FDA / IMDRF / Harmonized standards and GAMP to extract the basic principles of process validation. Building on from the basic requirements we examine the techniques of understanding the product specification, integrating risk management activities and setting the course for the validation activity. From validation master planning to setting up the validation study, this is a course specifically aimed at professionals who need to get on and manage highly complex validations. We bring together the statistics, engineering study and regulatory science coupled with quality assurance principles in order to ensure that you can leave feeling in charge of your next validation project. Any professional in a development, manufacturing engineering, quality assurance or supplier background where processes require validation. This course enables you to plan, implement and manage validation projects that are regulatory compliant. If you are a pharmaceutical quality professional you will find this course particularly interesting if you need to understand the differences between pharmaceutical and medical device process validation approaches. Chris Harris 7th-9th July 2015 Product Surveillance and Vigilance for CE Marking of This one day interactive course provides you with the simulated practices for interpreting adverse events and product quality trends in order to determine if vigilance action and reporting are required. Understanding whether adverse information requires vigilance action can often be more complicated than the basic requirements infer. In particular we cover the issues of understanding whether the product contributed to the adverse event, and the potential difference in interpretation from EU competent authorities. Within the course we examine periodic reporting, utilizing risk management as a means of informing vigilance action to regulatory agencies, and look at the potential impact of the EUDAMED database on the registration and sharing of data between agencies. Aimed at all professionals managing a medical device placed on the market and involved in any post market surveillance and vigilance, QMS feedback, clinical follow up and vigilance decision making activities. Authorized representatives and distributors will also find this module highly applicable to their function as critical operators within the supply and post market support of medical devices. Jonathan Hughes 20th April 2015 London Project Management for A Case Study Approach A one day course that provides you with an overview of the typical project planning activities that regulatory compliance specialists (regulatory / quality / product safety) may encounter. We critically evaluate project management principles and outline the key project plans that you may be involved in realizing, from CE marking step by step, process validation planning through to planning a change of notified body. The course is highly interactive and you get from it what you put into it. The course tutors are skilled in establishing and documenting project plans in a regulated environment and you will learn a lot more than you first may think in this area! The module is aimed at quality and regulatory professionals wishing to build upon their technical skills and move into formal career development by discussing project management, management and presentation behaviors. Marcus Orton 25th June th-13th May 2015

15 2 days 2 days Module 7: Working with Regulatory Agencies Module 2: Design, Risk and Safety Standards Module : Sterile Requirements Module 7: Working with Regulatory Agencies 28 Regulatory Agency Enforcement & Remediation for Medical Devices A two day course aimed towards medical device manufacturers that are actually or potentially in regulatory enforcement proceedings. The course takes you through how regulatory enforcement action is taken, from the simple generation of a quality system or technical file non-conformity to a whole scale multi competent authority lead safeguarding action. This two day course takes you through the necessary skills, report writing, coordination, project planning and legal interactions necessary to effectively address regulatory enforcement and also outlines in no uncertain terms the effects and likely impacts that can be expected when regulatory enforcement ensues. The course provides you with specific guidance as to how to work with and respond to regulatory agencies including notified bodies, Competent Authorities and European Commission agencies in the light of regulatory action. The course is aimed at personnel within the organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement. Risk Management for Software Based A one day course aimed towards the risk management and controls necessary for software based medical devices. This course provides practical guidance as to the harms, hazards and hazardous situations that software based devices may encounter. The course takes into account the most recent public health scares associated with cyber security and the potential hacking of implantable medical devices, infusion systems and patient data associated with diagnostic devices. We examine the state of the art approaches to controlling these risks and have information security and software engineering expertize to outline how a high degree of protection is established for software systems. Regulatory compliance professionals responsible for software based devices. Development and risk management experts new to software risk. Robert Cutts-Watson Duncan Keeble 17th April rd October 2015 Sterilization Process Requirements for Medical Devices Sterilization processes such as ETO, Gamma and Steam require detailed knowledge of the fundamental science, validation methods and the risks associated with poor understanding by personnel working with critical sub-contractors and process engineers in this area. This course will not ever claim to turn you into an expert in this area; however it will certainly arm you with the necessary fundamental understanding to challenge your approaches and implement essential controls over your suppliers, within your own processes and make informed decisions associated with changes in sterilization process parameters, loads or cycles. The course is designed for development engineers, manufacturing engineers, validation engineers, quality assurance and regulatory personnel involved in the design, validation and routine control of processes used during the manufacture of sterile medical devices. Simon Richards Henry Sibun 5th-6th March 2015 Structure of the Regulatory Agencies for A one day course aimed towards outlining the structure of regulatory agencies and the allied agencies involved in ensuring public health and safety is addressed within medical devices. This course focuses specifically upon the European regulatory agencies, expert groups and notified body coordination groups, providing you with essential intelligence as to how Europe really establishes regulatory oversight. If you are familiar with the medical devices, directives in Europe you will find this course absolutely essential to your future in medical devices as it demystifies how medical device legal, product safety and regulatory oversight is truly shaped and the bodies that come together to shape it. The course is aimed at personnel within the organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency both at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement. 11th May th-15th May 2015

16 Module 9: Biological Evaluation and Test Methods Module 8: The Professional Qualified Person Module : Pre & Post Market Technical File Data Module 16: Combination Product Requirements 30 Study Day Biological Evaluation and Product Safety for Complex Medical Technologies Participate in a day s seminar outlining the current methods of undertaking medical device biological safety evaluation. Come and listen to the best in the industry explain and outline the challenges, solutions and considerations impacting medical device design and manufacturing organizations in light of recent high profile material safety concerns. Over the last 5 years there has been a deepening concern that the method of understanding the safety of medical devices when considering biological risks has not encouraged the use of the most up to date scientific, engineering and regulatory methods. Several high profile failures relating to surgical implants have raised the level of concern from the US FDA, European Commission and subsequently the authorities responsible for overseeing medical device safety around the world. Standards setting groups have worked hard to bring standards into line with the latest considerations for risk management, testing, analytical methods and on-going control of materials and devices and there have been significant changes in how the assessment of clinical benefit over risk should be undertaken by manufacturers. This has culminated in the need for better risk management, better knowledge of the actual failure modes that can have an impact on biological stability when interacting with the human body and a better understanding of the tools and techniques to be used when validating the design, process and clinical efficacy of a medical device throughout its lifecycle. The Anticipated Role of the New Qualified Person for Medical Device CE Marking A one day course providing you with the necessary overview as to the anticipated role of the Qualified Person. We go beyond the basic requirement in Article 13 of the draft European Medical Device Regulation and take you through the practical realities about being responsible for medical devices at the specification development, manufacture, release, distribution and authorized representative areas. We outline the critical decisions you make, the specific competencies you require and drive home the practical experience and education expectations that will ensure you have the right people in the right place. We do not make claims about the similarity of the QP in pharma, instead we concentrate upon the very real issue of ensuring that the people managing regulatory compliance in medical devices are confident in their competence. The module is aimed at quality and regulatory professionals wishing to build upon their technical skills and move into formal career development by discussing project management, management and presentation behaviors. 23rd June 2015 The Design History File for One day course for quality and regulatory compliance professionals involved in the management of the design of medical devices. This course will enable the delegate to understand the requirements for Design History (particularly from the US FDA CFR21 Part ) and how to structure an effective DHF. Aimed at development, quality engineering and regulatory compliance professionals responsible for the development, management and update of the Design History File. This course will be of particular value to professionals involved in the retrospective build of Design History documentation. Duncan Keeble Marcus Orton 3rd February 2015 Understanding Combination Product Regulations A one day course aimed towards outlining the specific regulatory requirements for combination products. We explore the differences between the US regulatory requirements and those of the European Medical Devices Directives (including the impending new regulation). The course provides you with the necessary knowledge to determine what is a combination product, how regulatory agencies deal with combination products and the important interacting regulations that need to be considered for the device and the drug / biologic / combination product. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course. 27th April th September Alastair Selby + a whole host of international experts! 1th May 2015

17 Module 2: Design, Risk and Safety Standards Module 2: Design, Risk and Safety Standards Module 2: Design, Risk and Safety Standards Module 12: Supplier Quality Professional Understanding Design Control for Understanding Risk Management ISO 1971 for Understanding Standards for CE Marking of Understanding Supplier Control for CE Marking 32 From a recent review of FDA warning letters, EU notified body assessments and the specific introduction of combination product regulations, it is clear that the concepts and techniques used in design control and risk management are still unclear to manufacturers wishing to implement, improve and maintain their development processes. We take you through the requirements for combination product design and development processes subjected to CFR21 Part and the typical requirements defined in CFR21 Part , ISO 1385 and the European Directives. Once understood, we provide you with typical solutions to implement within your development processes, not least how to retrospectively address design of combination product device elements. Development, regulatory and quality professionals responsible for design control and design transfer of medical devices. This course demonstrates your expertize to coordinate, plan and control the necessary elements of design quality to produce a safe and effective medical device. Pharmaceutical quality professionals responsible for development of combination products will benefit from completing this course as it covers all aspects of the design control and design transfer requirements within CFR21 Part. Duncan Keeble ISO 1971 is a fundamental standard for all medical device developers, manufacturers and interested parties. We take you through the basics of Risk Management and the fundamental processes described in ISO Learn the process of risk management and the fundamental methods adopted by the medical device industry to demonstrate that the clinical benefit of a device outweighs its risks. From defining risk acceptability criteria to establishing the process to identify, evaluate and select appropriate control measures, this course will enable you to implement a robust risk management process. Development, regulatory, quality and product safety professionals responsible for the co-ordination of risk management activities. Duncan Keeble 15th April th October 2015 Standards are the life-blood of the European Medical Device CE Marking framework. As a quality, regulatory, development or other related professional within medical devices you will need to ensure that you are aware of the development, implementation, adoption and updates associated to standards and how manufacturers should react upon the adoption and introduction of these standards as harmonized standards within Europe. The course takes you through the general lifecycle of medical device related standards and introduces IMDRF guidance, TR1612 and the links between the medical device directive essential requirements and harmonized standards. Furthermore we examine the relationship between Risk and Standards as defined within ISO Guide 63:2012. From this foundation we then take you through the fundamental requirements and expectations of how a manufacturer adopts these standards either in full or partially, explaining how to plan for this within the design, technical data and post market change activities within your quality management system. Professionals with a responsibility for demonstrating through standards that a medical technology product is safe and performs within the CE marking requirements. Duncan Keeble 16th April st October 2015 A one day course taking you through the requirements for supplier control for a CE marked product. The course provides the requirements for supplier control, the definitions of critical sub-contractor and supplier, and outlines the main expectations from regulatory requirements associated with suppliers that undertake significant operations or provide significant services that may be deemed necessary for enhanced controls. If you are working with critical suppliers and subcontractors this course is one of a kind in that it provides you with the necessary requirements for how to suitably select, specify, qualify and monitor the supply chain. If you are a virtual manufacturer you will find this course particularly useful. 20th July th April 2015

18 2 days days Module : Sterile Requirements Module 16: Combination Product Requirements Module 9: Biological Evaluation and Test Methods Module 17: US Medical Device Regulations 3 Understanding the Requirements for Sterile One day course takes you through the basic requirements for CE marking of sterile medical devices. From basic microbiology and the definition of sterile through to the techniques required to validate facilities, packaging and sterilization processes, this course will enable you to understand the fundamental principles so you can plan the sterility of your medical devices. The course is designed for development engineers, manufacturing engineers, validation engineers, quality assurance and regulatory personnel involved in the design, validation and routine control of processes used during the manufacture of sterile medical devices. Simon Richards Henry Sibun 2nd March 2015 Understanding the Safety and Usefulness of a Medicinal Substance for a Medical Device This one day course is for all product safety professionals working with CE marked medical devices with a medicinal substance. We take you through how to project plan for the regulatory approval of the medicinal substance as well as outline the typical development planning, validations and test methods required in order to provide the EMA or national competent authorities with the data necessary to consider the safety and usefulness of the medicinal substance. If you are determining the regulatory pathway for a drug / device combination you will find this course particularly useful as it demystifies the requirements and provides you with the necessary project plan to determine the steps towards CE certification of a medical device with ancillary drug action. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course. 30th April th September 2015 Undertaking Biological Evaluation for CE Marking Step by Step Understand the implications of the regulatory developments in Europe and the proposed revision of the FDA Blue Book 5(k) Guidance in the Biological Evaluation of. The ISO 993 series of standards, covering biological evaluation of medical devices, is well established and regulatory authorities worldwide require compliance. In Europe compliance with the EN ISO 993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. The development of a European Regulation for Medical Devices is ongoing and significant changes are known or expected. New parts in the ISO 993 series are being developed, e.g. ISO TS , Guidance on Nanomaterials, and many existing parts are being revised. The key ISO 993-1:2009 is now up for 5 year systematic review and some revision is likely. This interactive seminar will provide opportunities for discussion, to have your questions answered, and realistic group exercises on these standards. This course is essential for any professionals responsible for product safety within medical devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill. Alastair Selby 12th-13th May rd-th November 2015 US Medical Device Regulations and Quality System Compliance Series A soup to nuts series on gaining entry into the US for medical devices, this course takes you from the initial regulatory planning, preparing the necessary pre-market documentation such as the Pre Market Authorization and Pre Market Notification (5K). Our course will enable you to effectively plan and communicate through project management the steps necessary to achieve US regulatory approval. Day 3 and Day then take you through the important aspects of developing a regulatory compliant quality management system, including an overview of the CFR21 Part 820 and implementation strategies that go beyond the basic understanding of requirements. Our course is a brand new course, aimed towards those European medical device manufacturers that wish to anticipate the journey from CE marked device to US regulatory cleared. This course is for quality and regulatory affairs professionals, including: Employees responsible for product submissions Design development teams Employees responsible for product life-cycle management Management representatives Marketing personnel Steve Yost 8th-11th June st-th December

19 The right people. The right solution. The first time. Our European Medical Devices Module Owners From the strongest roots, come the greatest fruits Course Fees Our prices represent excellent value for money. Our courses are highly interactive and the tutors are on hand throughout to answer your questions, so you ll be ready to put what you ve learnt into practice. You will also be provided with comprehensive course materials, which will be an essential reference tool when you return to work. A perfect blend of regulatory agency, industry and medical device product safety expertize, our module leaders are committed to ensuring that you discover and practice the solutions required to meet the most complex regulatory compliance challenges our industry will face., MCQI CQP Vice President, Europe At NSF Health Sciences we are proud of our heritage. With our roots firmly placed in public health and safety, we have grown our services to provide you the very best practices, solutions and methods globally, in line with our mission If you are wondering Who is NSF Health Sciences?, we invite you to remember our roots in David Begg Associates, Becker & Associates, Pharmalytica Services, Medwise International and Pink Associates. Each of these organizations contributed unique services and helped us become who we are today. 36 Standard Course Fees Course Duration 2015 Prices days 2550 per delegate 3 days 19 per delegate 2 days 170 per delegate 735 per delegate Discounts available: Second delegate from same site: 20% Further delegates from same site: 50% Please note that all prices are in Sterling and VAT is payable where applicable. Cannot find what you are looking for? If not you are always welcome to suggest a training course, we have over 25 years experience in the development of highly complex regulatory, compliance and product safety training, with a wealth of expertize at our fingertips. Whether it is technology specific adapted training or other regulatory regimes, we are capable of putting together a program that will meet and exceed your needs. Just ask. has 17 years experience in the medical devices industry including years as a HealthCare Technology Expert and Lead Auditor for a leading European notified body. His industry experience includes managing development and quality assurance programs for software based devices, non-active orthopaedic, cardiovascular, wound and combination products as well as active therapeutic devices. James has responsibility as head educator for our overall medical device Qualified Person professional development program and module leader for design, quality assurance, process validation, medical device professional auditor, software QARA and US medical device QARA modules., PhD BSc Hons DABT Executive Director, Regulatory Science and Product Safety is an internationally renowned medical technology product safety specialist with over 30 years experience and achievements in pre-clinical R&D, medical surveillance, regulatory support, and training. John has responsibility for our medical device clinical requirements, sterile medical devices, biological evaluation and drug/device combination product safety modules. For more information about NSF courses, [email protected] or visit our website at Education David Begg Associates Established 1986, David Begg Associates gained its reputation as a professional training organization central to the formation of pharmaceutical Qualified Person training. It was responsible for the education and career development of some of the highest profile decision makers in the pharmaceutical and bio-technology industries. With global education capabilities including specialist in-company education modules, the formation of NSF Health Sciences has enabled our training and education processes, revered by thousands of students, to be diversified into the medical technology and in-vitro diagnostics industry to prepare the next generation of high performing medical device regulatory compliance professionals. Consulting Becker & Associates and Pink Consulting Established 2002, Becker & Associates Consulting was a respected regulatory consulting practice in the pharmaceutical, biotechnology and medical device sectors. Known for its team of ex Food and Drug Administration senior personnel, Becker & Associates had a pedigree in the successful project management of FDA enforcement action remediation, including Form 83s, warning letters, recalls, import detentions, consent decrees and license revocations. The integration of Becker & Associates tried and trusted approach to multisite, global remediation project management as well as its deep knowledge of FDA policy has brought a high-octane consulting approach to NSF Health Sciences consulting services. Coupled with the integration of Pink Associates and its team of ex European regulatory agency professionals, our global footprint enables us to manage regulatory strategy, quality systems implementation and regulatory enforcement action remediation on a multi-agency and truly global basis. Bristol Laboratories Pharmalytica Services Established 2000, Pharmalytica Services brought analytical testing, consulting and R&D services to the pharmaceutical, medical device and biotechnology industry. Now part of NSF Health Sciences, the Pharmalytica GLP and GMP contract laboratory offers a wide array of independent testing and analytical services for pharmaceutical, medical device and biotechnology companies. The lab specializes in extractables and leachables testing for combination products, drug delivery and drug/device combinations. 37

20 The right people. The right solution. The first time. Consulting Audit and Inspection 38 Compliance and Remediation Our consulting services range from short-term requests for technical expertize to the provision of multiple expert resources engaged in fast moving, mission critical regulatory enforcement remediation. Whether you need to understand how to appropriately respond to an FDA form 83 or you need to establish a method of transferring your notified body, our consultants can effectively guide you through your regulatory compliance initiatives. Our experience with international regulatory agencies and our model for managing FDA and EU remediation under legally imposed sanction can help you achieve regulatory compliance with confidence. We have the program methodology, resource identification and project management expertize to plan and manage complicated and globally disparate consulting engagements. With decades of working in highly charged, stressful and culturally sensitive manufacturing facilities, we are focused on achieving your compliance goals and often provide a calming influence to the most pressurized of situations. Pre-Clinical, Clinical and Product Safety Consulting Whether you require consultation relating to the development of novel product test methods or to understand your options for bio-compatibility testing for international global market access, we can guide you on your product development path. Our team of internationally renowned product safety and clinical professionals includes clinical, toxicology and drug safety experts with over 20 years of experience in the medical technology and combination product field. Our consulting ranges from one-time consultation on specific scientific and technical issues to the project management of product specific testing and subsequent safety and/or clinical evaluations. International Regulatory Strategy With our team of ex FDA policy level experts within ORA, ODE, CDRH, CBER and CDER, we can help you achieve the appropriate regulatory strategy for market entry into the U.S. with a high degree of certainty as to your commercialization strategy. Our regulatory team work with you throughout the regulatory lifecycle to establish initial pre market, on market and post market regulatory strategies. Our EU expertize includes competent authority, notified body and European expert committee members. As ex international regulatory agency professionals, many with more than 20 years of agency experience, we are equipped to undertake pre-approval inspections, mock FDA inspections, mock notified body initial, surveillance and unannounced audits as well as an array of specialized audits to meet your needs. Our people have specific technology, clinical and regulation expertize to ensure that the most challenging of assessments can be conducted to a high degree of satisfaction. Our audit and inspection styles can mimic the toughest agency approaches to adequately prepare your systems and people and to identify the real vulnerabilities and risks to your regulatory compliance. Or you can ask us to be more collaborative and undertake audits and inspections in a hat s off and passive coaching style. With resources placed around the world, you will find The right people. The right solution. The first time. Education The Medical Device Regulatory Compliance Professional Since we were founded as David Begg Associates in 1986, we have been driven to provide the latest world-class education for regulatory compliance professionals. The medical device industry is about to face an unprecedented change in the way that it is regulated, with higher scrutiny from global regulatory agencies. Based on our successful Qualified Person training for pharmaceutical quality professionals, we have developed a similar program for medical device regulatory compliance professionals. The program consists of high quality, engaging and intense modular training that ultimately prepares the Qualified Person to be able to make the right decisions in the interest of public health. We introduced our first series in our QP medical device curriculum in 201, offering specific modules, professional certificates and international post graduate qualifications in conjunction with the Sheffield Hallam University. 39 For more information about NSF courses, [email protected] or visit our website at

21 2015 January to June Training Course Calendar 0 January Regulatory Horizon Medical Devices Compliance Horizon Medical Devices Product Safety Horizon Medical Devices Planning for the Revision of the IVD Directive 98/79/EEC 28 IVD CE Marking Regulatory Requirements Step by Step 29 IVD CE Marking Technical File Compilation & Management 30 IVD CE Marking Standards, CTS and Performance Evaluation 31 February The Design History File for Medical Devices CE Marking Preparing and Managing Technical Documentation ~ 3 days 5 6 Design Control for Combination Products CE Marking Medical Device Software Regulatory Requirements Step by Step Planning and Conducting Clinical Investigations for Clinical Evaluation Step by Step Current Approaches to CE Marking Software (ehealth, Apps and Stand-Alone) 11 CE Marking for Medical Device Software Technical File and Quality System Requirements 12 Post Market Clinical Follow Up for March 1 2 Understanding the Requirements for Sterile 3 Implementing the Requirements for Sterile 5 Sterilization Process Requirements for Introduction to ISO Implementing ISO 1385 A Project Management Approach ISO 1385 Advanced Effective Change Control 20 ISO 1385 Advanced Effective CAPA Investigations Planning for the Revision of the IVD Directive 98/79/EEC 2 IVD CE Marking Regulatory Requirements Step by Step 25 IVD CE Marking Technical File Compilation & Management 26 IVD CE Marking Standards, CTS and Performance Evaluation April Understanding Design Control for 1 Implementing Design Control for 15 Understanding Risk Management ISO 1971 for 16 Understanding Standards for CE Marking of 17 Risk Management for Software Based Product Surveillance and Vigilance for CE Marking of 21 Field Safety and Recalls for CE Marked Post Market Surveillance Plans for CE Marked Understanding Combination Product Regulations 28 Combination Product Risk Management and Biological Evaluation Key Issues Understanding the Safety and Usefulness of a Medicinal Substance for a Medical Device May How to Audit Series Advanced Auditing techniques 6 7 How to Audit Series Advanced Audit Techniques Notified Body Auditing Techniques 8 How to Audit Series How to Audit Combination Products 9 11 EN ISO 993: Biological Evaluation of Structure of the Regulatory Agencies for 12 Pre Market Technical Briefings for Undertaking Biological Evaluation for CE Marking Step by Step 13 1 Regulatory Agency Enforcement & Remediation for Study Day Biological Evaluation and Product Safety for Complex Medical Technologies CE Marking Requirements for Medical Devices Understanding and Preparing for the New EU Regulation 19 CE Marking Requirements for Medical Devices Implementing CE Marking Requirements for Medical Devices Complex Borderline and Class III June US Medical Device Regulations and Quality System Compliance Series ~ days The Anticipated Role of the New Qualified Person for Medical Device CE Marking 2 Communicating Quality and Regulatory Strategy to Senior Leaders and Investors for Medical Device CE Marking 25 Project Management for Medical Devices A Case Study Approach Cannot find what you are looking for? If not you are always welcome to suggest a training course, we have over 25 years experience in the development of highly complex regulatory, compliance and product safety training, with a wealth of expertize at our fingertips. Whether it is technology specific adapted training or other regulatory regimes, we are capable of putting together a program that will meet and exceed your needs. Just ask

22 2015 July to December Training Course Calendar 2 July Process Validation for Planning and Conducting ~ 3 days CE Marking Medical Device Software Regulatory Requirements Step by Step Planning and Conducting Clinical Investigations for 1 CE Marking for Medical Device Software Technical File and Quality System Requirements Clinical Evaluation Step by Step Clinical Evaluation of Medical Device Software for CE Marking Post Market Clinical Follow Up for Understanding Supplier Control for CE Marking 21 Implementing Supplier Control for CE Marking August September Understanding Combination Product Regulations 16 Combination Product Risk Management and Biological Evaluation Key Issues Understanding the Safety and Usefulness of a Medicinal Substance for a Medical Device CE Marking Requirements for Medical Devices Understanding and Preparing for the New EU Regulation 22 CE Marking Requirements for Medical Devices Implementing 23 2 CE Marking Requirements for Medical Devices Complex Borderline and Class III Cannot find what you are looking for? If not you are always welcome to suggest a training course, we have over 25 years experience in the development of highly complex regulatory, compliance and product safety training, with a wealth of expertize at our fingertips. Whether it is technology specific adapted training or other regulatory regimes, we are capable of putting together a program that will meet and exceed your needs. Just ask. October Introduction to ISO Implementing ISO 1385 A Project Management Approach 7 8 ISO 1385 Advanced Effective Change Control 9 ISO 1385 Advanced Effective CAPA Investigations Implementing Design Control for Planning for the Revision of the IVD Directive 98/79/EEC 20 IVD CE Marking Regulatory Requirements Step by Step Understanding Risk Management ISO 1971 for 21 IVD CE Marking Technical File Compilation & Management Understanding Standards for CE Marking of 22 IVD Clinical Data and Post Market Surveillance Plans Planning for Content Deviations in ISO 1971: Risk Management for Software Based November 1 2 EN ISO 993: Biological Evaluation of 3 Undertaking Biological Evaluation for CE Marking Step by Step How to Audit Series Advanced Auditing techniques 11 How to Audit Series Advanced Audit Techniques Notified Body Auditing Techniques 12 How to Audit Series How to Audit Combination Products Planning and Conducting Clinical Investigations for 2 Clinical Evaluation Step by Step Post Market Clinical Follow Up for December 1 US Medical Device Regulations and Quality System Compliance Series ~ days

23 3 easy ways to book your place Online For further details about all of the courses we offer visit our website. By Just drop us an letting us know which course you are interested in and we will send you full details and booking information. By phone + (0) Our phones are manned between and Monday to Friday. Outside these hours you can leave a message and one of our team will return your call as quickly as possible. Web [email protected] Tel + (0) Post NSF Health Sciences Advanced Manufacturing Park Brunel Way Rotherham S60 5WG LMD-716-1