Global experts in Remediation, Auditing, GMP Compliance, Education and Regulatory Affairs for the Pharma and Biotech Industry

Transcription

1 Global experts in Remediation, Auditing, GMP Compliance, Education and Regulatory Affairs for the Pharma and Biotech Industry

2 The right people. The right solution. The first time. Quality Systems Compliance, Remediation and Auditing services in compliance and quality systems provide efficient and forward-looking compliance solutions to our clients. Our staff of former EU and FDA officials as well as industry experts allows us to combine global regulatory knowledge with industry best practices to help our clients achieve a compliant quality system that is right for their business. We provide services to pharmaceutical, biologics and biotech companies and offer solutions tailored to your industry requirements and company-specific objectives. We ensure the quality and consistency of our solutions, by integrating senior management and employee involvement in developing practical solutions that lead to ownership and sustainability. Our systems-based approach ensures deficiencies are identified and addressed at their root cause, appropriate corrective and preventive actions are developed, and linkages between the quality subsystems are integrated to ensure sustainable and practical compliance. We support companies efforts to develop or enhance their quality systems, both proactively and in response to regulatory actions. We also provide auditing and assessment services to ensure companies and their suppliers are compliant, and offer practical and sustainable solutions to address your needs. Specific services include: Quality systems remediation, development and implementation The Quality Enhancement Program (QEP ) is NSF s approach in the USA to remediate, enhance or streamline a company s quality management systems (QMS). The program is adaptable, scalable and specifically tailored to achieve compliance with a company s specific needs and objectives. We: > > Identify deficiencies and determine their root cause > > Develop a risk-based, prioritized corrective action plan > > Create joint NSF-client teams to ensure sustainable and practical solutions > > Provide interim senior leadership and SME support roles > > Offer expertise in statistical methods and analysis: cost of quality (CoQ), sampling plans, stability models, DOE, SPC, process control, capability (CpK, PpK), root cause analysis and process optimization > > Have considerable pecialized experience in clinical and bioresearch areas including BIMO, CLIA, GLP and GCP >>>

3 > > Can provide coaching and mentoring for all roles and levels within your organization > > Offer task - and function-specific training: investigations, root cause determination, laboratory, etc. Auditing and assessments > > Gap assessments > > Mock FDA inspection and FDA-readiness support > > Mock European regulatory agency audits > > Data integrity audits > > Third-party audit of CMOs and suppliers: Rx pharma and OTC pharma, API, laboratory, etc. > > Due diligence assessments for large and small-scale acquisitions Remediation, compliance and enforcement action support > > 483 response/remediation expertise > > Warning letter response/remediation expertise > > Consent decree (injunctions) work plan development and remediation > > Application Integrity Policy (AIP) resolution > > Corrective action plans development and execution > > DWPE import alerts/restrictions/detentions Training > > 21 CFR 210/211 cgmp for finished pharmaceuticals > > 21 CFR 600 and 610 for biologics > > PAI audit readiness > > Quality system subsystem-specific training sessions including CAPA, management review and risk management For more information about, visit our website at pharmamail@nsf.org or call LPH

4 The right people. The right solution. The first time. GMP Compliance Consulting and Education for the Manufacture of Biotech and Biological Products Biotech and biological production is a large and quickly growing industry sector with rapidly evolving regulation. When the dosage form must be provided free from microorganisms, harmful pathogens, endotoxin and particulates, the importance of effective quality oversight grows exponentially. As a pharmaceutical professional, you need to be sure that all aspects of the quality system are designed, controlled and monitored to detect and mitigate potential deficiencies in the quality assurance of the product. In the manufacture of biotech and biological products, being able to make the right decisions from the right information in a timely manner is critical, and getting it wrong can have disastrous consequences. Defining a highly complex production process that delivers a complex, often delicate long chain molecule requires a high level of knowledge and insight. As your product is often defined more by the process than by any laboratory characterization methods, you need to be able to develop effective process design, process validation and ongoing monitoring; change management processes; and QA oversight, including the ability to accurately act on signals, defaults and out-of-trend parameters. can help to achieve this through world-class consulting and training services. We have led projects that turned around companies: > > Struggling to react and respond thoroughly to regulatory non-compliance statements (eg FDA warning letters) > > Failing to see the bigger picture when designing or modifying major production facilities > > Failing to manage expectations regarding viral and microbial contamination controls Our projects have helped these companies: > > Return their facilities to GMP compliance following regulatory non-compliance statements within 18 months of the original inspection > > Restart their bio production facilities after major contamination issues within 12 weeks of the signal > > Put their biosimilar drug substance facility design back into compliance within two site visits >>>

5 We are trusted with strategic assignments across all aspects of GMP compliance for biotech and biological products: > > Corporate due diligence, risk assessment and specialist consultancy when acquiring or merging with bio production facilities outside your organization > > Strategic and specialist GMP education programs tailored to your company s particular technology GMP for biotech and biological production Pharmaceutical microbiology Good autoclave practice Risk-based decision making for steriles and bio QPs We can provide bespoke courses for your technology, tailored to meet your learning objectives and effect sustainable change in behaviors, processes and procedures; always linked to a predetermined return on investment. > > Courses brought on-site to allay any concerns with budget or focus GMP remediation programs that provide a sustainable, proportionate and comprehensive roadmap to survive and then thrive in the field of bio and biosimilars manufacturing > > GMP inspections of bio products facilities encompassing, eg Biological and blood products Vaccines Antibody drug conjugates Monoclonal antibodies Biosimilars For more information about, visit our website at pharmamail@nsf.org or call LPH

6 The right people. The right solution. The first time. GMP Compliance Education for the Manufacture of Sterile Products Manufacturing a pharmaceutical product is not easy and the multi-faceted quality system designed to deliver a safe, efficacious product is not to be underestimated or neglected. When the dosage form has to be provided free from microorganisms, harmful pathogens, endotoxin, and particulates, the importance of effective quality oversight grows exponentially. As a pharmaceutical professional, you will want to be sure that all aspects of the quality system are designed, controlled and monitored in a way that can detect and mitigate potential deficiencies in the quality assurance of the product. In the manufacture of sterile products, being able to make the right decisions from the right information in a timely manner is critical and getting it wrong can have disastrous consequences. Consequently, you must develop an approach that provides insightful and proportionate input into product quality and patient safety. You are expected to have core knowledge of the key processes that minimize risk and assure your product quality attributes are met right first time. You are expected to have experience on how facilities, utilities and equipment combine with effective and well trained staff; making sure that the assembly, sterilization and key process steps are executed and documented to cgmp. NSF Health Sciences steriles education program can help you there and ensures your people know: > > cgmp expectations > > The responsibilities of their job role and those around them > > The function and critical operating parameters associated with common sterile facilities, utilities and equipment > > The critical process steps in manufacturing aseptic and terminally sterilized products; and what to do when they default against expectations NSF Health Sciences education programme in this field is trusted and recognized as best in class. > > We have delivered the external course core programme (A-Z of Steriles Manufacturing) to more than 300 people over the past five years with delegates from all of the major pharma companies and international regulatory bodies >>>

7 Internally to a multi-disciplinary group of employees needing the same message or coaching > > This demonstrates the value that organizations attach to our approach and our course content; and tailored internal courses are recognized as a highly economic, convenient and bespoke option for many international organizations. Best training I have attended for sterile manufacturing course. NSF used very experienced and patient trainers. Great job with visual and hands on building of facilities. It was interesting and really easy to understand. July 2014 For information on our available courses around the manufacture of steriles, visit our website at pharmamail@nsf.org or call LPH

8 The right people. The right solution. The first time. Pharmaceutical and cgmp Education Programs The pharma biotech sector continues to face unprecedented levels of change as a result of both the economic and regulatory environments we face. The need for a pharmaceutically well-educated and motivated workforce at all levels, that understands not just the whats but also the whys, has never been higher. In addition to our core courses in quality management, we are continuing to add courses in areas of increased industry focus such as auditing and supply chain topics to allow you to keep current and continue to develop as pharmaceutical professionals. Training approach At we believe that training should involve the transfer of knowledge in an effective and enjoyable fashion. When you leave our courses, we want you to retain information and put it to immediate use. Therefore, you will find our courses to be highly interactive and participatory, employing case studies and creative exercises. Each of our trainers has extensive industry experience and is highly qualified to impart knowledge in a classroom setting. We design our courses to help trainers convey information in the most effective manner. offers several options to help your company educate and train your staff, from operators to senior leaders. Give your company a leading edge by developing your staff s understanding of the pharmaceutical sector to enhance their risk-based, decision-making. On-site training: We bring the experts to you is globally recognized as a provider of top quality on-site training. We provide professional development of your staff to help them understand the basics and learn the new and constantly changing expectations of global regulators and legislators. Our on-site modular program is customized based on your needs and focused on the education that QPs (Qualified Persons) need to perform their jobs, expanded to account for the global nature of industry (covering EU, US and other international markets). The program generally consists of 12 modules run over 12 to 18 months, with each module typically lasting four to five days. The program enables your staff from a variety of departments to truly understand the regulations, legislation and current Good Manufacturing Practices (cgmps): why these exist, >>>

9 what the risks are and how they affect their specific role. Each module is interactive, combining classroom lectures, learning activities and teamwork as well as the possibility for internal projects. Our staff works with your company to identify the appropriate modules and content. Course materials and case studies are based on your company s products and procedures. Customizable modules include: > > Human Reliability: Human Error Reduction (understanding causes and tools for prevention) > > Global GMPs and Inspection Readiness > > The Role of the Qualified Person or Release Professional > > Quality Systems (commercial and R&D) > > Pharmaceutical Analysis and Testing > > Pharmaceutical Law & Regulation (global: includes recent changes and hot topics) > > Supply Chain > > Emerging Markets > > Components and Dosage Forms (API, excipients, small molecule, large molecule, vaccines) > > Specific Technologies (steam sterilization, environmental monitoring, pharmaceutical packaging, microbiology) > > Corporate Integrity Public courses We also offer a variety of education classes where your staff can interact with individuals from other companies. The courses cover the same selection of topics as the on-site program but provide more general, industry-wide examples and case studies. Courses range from one-hour webinars to half-day to four-day programs, with a balance of lecture, discussion and interactive activities. For more information about, visit our website at pharmamail@nsf.org or call LPH

10 Meet our Staff We help you enhance and embed the right culture throughout your organization. Martin Lush, MSc, FIBMS, PG Dip, EU Qualified Person, CBiol President, Martin Lush has over 30 years experience in the pharmaceutical and healthcare industry. He has held senior management positions in QA, manufacturing, QC and supply chain auditing and has conducted audits and education programs for many hundreds of companies in over 25 countries. A microbiologist by profession, Martin has considerable experience in the manufacture, quality assurance and testing of aseptic products. He is also qualified to act as a Qualified Person within the EU. He holds a master s degree in medical microbiology, a BSc in medical science and a postgraduate diploma in quality management systems. He is also an honorary lecturer at the School of Pharmacy, University of Strathclyde, Scotland. Martin has been involved in the design, qualification and operation of over 15 plants manufacturing sterile products. Passionate about continuous quality improvement in the pharmaceutical industry, he believes that most pharma companies are years behind industries such as automotive and micro-electronics. He is currently working with many companies to help them close this gap. Martin is respected for his expertise in helping companies simplify and dramatically improve their quality systems by removing non value-adding operations and improving compliance at minimal cost. Other areas of expertise include: > > Crisis management: Helping companies survive severe regulatory action (consent decrees and warning letters) > > Quality systems: How to simplify and improve operational effectiveness > > Quality leadership: Helping you to get the best from your people > > Human error: Causes and prevention > > Error reduction and process improvement > > The design and implementation of efficient and simple change management systems > > Deviation and CAPA systems that drive continuous improvement > > Troubleshooting and problem solving to root cause > > Training and education effectiveness (as a qualified practitioner of accelerated learning teaching methods) > > Batch record review and product release procedures > > Performance measure development

11 Meet our Staff We help you enhance and embed the right culture throughout your organization. Peter Gough, MSc, CSci, CChem, FRSC, FCQI, CQP Executive Director, A chemist with a master s degree in analytical chemistry, Peter Gough has over 40 years experience of pharmaceutical manufacture, control and quality management, culminating in the role of Senior Quality Consultant in Eli Lilly s Global Quality Systems division. He has broad experience, particularly with quality control laboratories and the manufacture of solid dosage forms and active pharmaceutical ingredients. Peter has extensive experience defining quality systems at a global level. He is eligible to act as a Qualified Person and is an honorary lecturer in GMP and Pharmaceutical Quality Management at the University of Strathclyde, Scotland. He is a former member of the European Federation of Pharmaceutical Industry Association s (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 Quality Risk Management Guideline. He was given the Leveraging Collaboration Award by the US FDA for his contribution to the online ICH Q9 briefing pack. He has been a passionate advocate of the Quality by Design (QbD) approach to the development, registration and manufacture of pharmaceuticals. Areas of recognized expertise include: > > Pharmaceutical law > > The role and duties of the Qualified Person > > Pharmaceutical quality management systems > > Pharmaceutical quality risk management > > Good Control Laboratory Practice (GCLP) > > Managing out of specification (OOS) and out of trend (OOT) results > > The application of statistical process control tools > > The manufacture and control of oral solid dose products Peter is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and former chairman of the Royal Society of Chemistry s Qualified Person Assessor Panel and of the CQI s Pharmaceutical Quality Group.

12 Meet our Staff We help you enhance and embed the right culture throughout your organization. John Johnson, FRSC, CChem, MIQA Executive Director, John Johnson is passionate about helping organizations foresee and overcome the barriers to sustainable long-term growth. He brings 28 years experience across a range of companies in the pharmaceutical and healthcare industry. He has worked in small, medium and large pharma biotech companies across the product lifecycle for a wide range of dosage forms. He has senior operational and corporate-level experience in operations and quality assurance and has led multinational companies in strategic projects associated with: > > Inspection readiness and remediation (in the UK, Italy, France, Australia, Singapore, India and the USA) > > Crisis management including handling of regulatory authority actions, multinational recall and import bans > > Major culture change to improve customer service, quality, cost or on time in full > > Installation, monitoring and periodic effectiveness checks on site or company quality management systems > > Paradigm shifts including downsizing, upsizing, mergers and acquisitions > > QP development, training, mentoring and resource management > > Lean projects in QC laboratories and OSD facilities > > Management review and escalation processes from shop floor to boardroom level John has used research with subject matter experts from Toyota and Tata to help firms streamline and simplify complex processes and procedures to reduce cost, rework, rejects and human error. By working with a range of companies across a variety of cultures, dosage forms, business plans and geographies, he has acquired a style that has a proven methodology yet is easily tailored to suit the particular need. A QP since 1995 and a QP Assessor since 2005, he has been a sponsor and mentor for QPs, some of whom are QA department leaders. As a Fellow of the Royal Society of Chemistry, he is laser focused on the value that good analytics bring to batch dispositioning decisions and has a particular expertise in data-based, quality risk management. Utilizing a range of development tools and techniques, John has been responsible for developing quality and operational teams to be aligned and engaged with the company s strategy so that the team s combined output is driven by a performance culture that is self-governing yet capable of constant reanalysis and refreshment. He has also written articles for a variety of pharma publications.

13 Meet our Staff We help you enhance and embed the right culture throughout your organization. Mike Halliday, MRPharmS, PGDip Vice President, Mike Halliday has extensive experience over 20 years in the pharmaceutical industry, in roles in manufacturing and QA management. Mike has added to this experience as a trainer and consultant since joining NSF in His experience has included new factory start-up and supply chain rationalization in global projects. Mike has provided internal technical and quality support to suppliers and own company sites. A key part of this role was joining and then managing a global audit group, assessing company and supplier manufacturing sites worldwide for a major multinational pharmaceutical company. Audits covered all key dosage forms and manufacturing processes. Mike is a pharmacist by profession and training, and is eligible to act as a Qualified Person with the EU, holds a postgraduate diploma and is an honorary lecturer at the University of Strathclyde, Scotland. > > Mike is a keen believer in the importance of people to any organization: Mike brings this expertise to: > > QP training > > Auditing > > GMP Selection, management, leadership, education and development Understanding roles and responsibilities within the site and the Quality Management System Helping potential QPs become the best QPs and quality leaders possible. He runs the NSF QP training program Training and developing Mike runs the NSF certified lead auditor program Getting the foundations right running the GMP training and development program > > Manufacturing operations > > Designing, developing and delivering training courses that develop and encourage. To be memorable, training should be enjoyable LPH

14 Meet our Staff We help you enhance and embed the right culture throughout your organization. Rachel Carmichael, BSc, MSc Executive Director, Rachel is a biochemist with a master s degree in industrial pharmaceutical studies and is a member of the Royal Society of Biology. She is eligible to act as a Qualified Person under the provisions of EU Directives. Rachel has over 20 years experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, the MHRA. Rachel has wide ranging experience of inspecting against European Good Distribution Practice and Good Manufacturing Practice requirements in the UK, China, India and the US, meeting the associated quality standards for medicines (non-sterile and aseptic production, including radio pharmaceuticals) and the blood industry. Areas of recognized expertise include: > > Manufacture and Packaging of oral solid dosage forms > > Good Distribution Practice > > Good Manufacturing Practice > > Blood industry - blood establishments, hospital blood banks and plasma collection sites > > Data integrity > > Pharmaceutical law Rachel was the lead Inspector representative within the MHRA for the transition from the Medicines Act to the Human Medicines Regulation, SI LPH

15 Our Global Presence Ann Arbor, MI Bristol, CT Washington, DC York, UK Brussels, Belgium Berlin, Germany Rheda-Wiedenbrück, Germany Shanghai, China NSF Health Sciences Other NSF Locations NSF Partner Locations Lima, Peru NSF Health Sciences Locations NORTH AMERICA > Ann Arbor, MI > Bristol, CT > Washington, DC EUROPE > Berlin, Germany > Rheda-Wiedenbrück, Germany > Sheffield, UK > York, UK LATIN AMERICA > Lima, Peru ASIA > Shanghai, China For more information about, visit our website at LPH