2 Day Seminar Assuring Data Integrity in the Life Science industry

Transcription

1 2 Day Seminar Assuring Data Integrity in the Life Science industry Location 1: Boston Sep Hilton Garden Inn Boston Logan Airport 100 Boardman Street, Boston, MA Hotel: Location 2: San Francisco, CA Sep Homewood Suites by Hilton San Francisco, 2000 Shoreline Court, Brisbane CA USA Seminar One Registration $ 995 Special Group Discount Register for Four attendees $ 3195 Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant s RAC recertification upon full completion Each attendee will receive 2-Day workshop materials,certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS. COURSE SUMMARY In the face of aggressive audits by regulatory agencies, life sciences companies continue to face unprecedented compliance challenges in ensuring data integrity. Such audits are unlikely to abate anytime soon. On the contrary, the agencies are hiring very highly literate computer experts to audit and aggressively pursue data integrity issues during audits. In the past four years, highly visible audits and investigations coupled with aggressive prosecution have resulted in significant financial judgments against even the most leading life sciences companies. Consequently, companies can no longer ignore the heightened challenges of ensuring data integrity in their enterprise. Business expediency requires them to train their personnel in understanding data integrity so that they can effortlessly identify and remediate potential data integrity problems before the auditors do so.

2 This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world, this workshop provides participants with the knowledge, approaches and techniques to effectively establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for novices as well as experienced personnel from QA, IT, manufacturing, laboratory, regulatory and validation groups. It should also be of special interest to mid-level as well as senior level management. Addressed will be data integrity case studies, inspection approaches and 483s and warning letters. Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc. Some training highlights... What is Data integrity Data Life Cycle design and controls Attributes of Data Integrity and how they map to predicate rules How do you know you have a Data Integrity problem in your company Elements of a Data Integrity Assurance program Roles and responsibilities of different groups in ensuring data integrity What data integrity SOPs do auditors expect to see during audits and should their contents be Validating Data Integrity THE TRAINER Chinmoy Roy BSEE, MSCS Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems Chinmoy Roy has 35+ years of experience. He is an internationally recognized subject matter expert in Data Integrity, CSV, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu s annual conference for Asia Pacific, etc. His expertise stems from his experience in implementing and obtaining fit for use certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA s issuance of Part 11 s Scope and Application guidance in His workshops are

3 unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate. What past attendees are saying: I attended Chinmoy s CSV/Part 11/QRM training provided at our facility. His adroit answers to our application specific questions were very impressive and demonstrated the depth of his field experience and knowledge of regulatory requirements.. Mr. Biswajeet Mitra, Senior VP, Jubilant Lifesciences I attended Chinmoy's overview of computer system validation at the June 2011 ISPE India Affiliate conference and found it to be a comprehensive overview of the current state of regulatory and industry guidance. It provided a broad perspective, introducing the many necessary elements and was well received by the audience. Mr. David Stokes, Global Lead, IS Consulting & Compliance Chinmoy visited our company for an in house training of our employees from several of our plants. I took the opportunity to be present for the training. I was impressed by the depth of his knowledge, both practical and regulatory, and the manner he approached our compliance questions that some the trainees brought to the class." Dr. D. Haldankar, Head Corp. Quality, Cipla Ltd. A Very Well organized event. The Speaker was just marvellous in driving to a depth of my understanding of Data Integrity and 21 CFR Part 11 aspects. Sajan B. Balabhadran, Watson Pharma Pvt Ltd. I have interacted with Chinmoy during an in-house workshop organized for Dr. Reddy's employees on 'Computer Systems Validation'. It was extremely well handled and all participants thoroughly enjoyed the session. He gives complete knowledge required to understand the gaps in current systems and required details to work on them to improve. Would surely love to work with him again P. Dayakar Reddy, Associate Director, Training, Dr. Reddy s Labs. I, along with several of my colleagues attended two training workshops provided by Chinmoy in India last year. The first was on Data Integrity. During that workshop, he laid out fundamental concepts of Data Integrity along with case studies. He also suggested establishing a Data Integrity infrastructure which included the development of a collection of Data Integrity policy and directive documents. After the training, we followed his suggestions and established our Data Integrity infrastructure. We successfully passed Data Integrity audits thereafter. Our management was very happy with our accomplishments and approved a larger group to attend Chinmoy s training later on in the year. We are very impressed with his abilities to present the fundamental concepts, suggest practical solutions along with case studies and most of all answer our application specific questions. We certainly found him to be an implementation expert in establishing a Data Integrity infrastructure that regulators expected us to establish. Additionally, he has a unique style of training. He does not believe in running through the slides, but prefer to interact with the attendees and help them answer their questions. Mahadev Desai, Senior Manager, QA, Johnson and Johnson

4 TRAINING WILL BENEFIT: Ø Pharmaceutical industry / Medical device industry / Healthcare industry personnel Ø Developers of software for use in Life Sciences industry Ø Validation service providers, IT service providers Ø Manufacturing personnel, Manufacturing Automation system vendors and system integrators Ø Regulatory Affairs group, Quality Unit Ø Laboratory personnel TRAINING TAILORED TO ACHIEVE THE FOLLOWING GOALS: Ø What are the recent regulatory changes for Data Integrity Ø What should be the management structure for DI accountability Ø What are the documentation requirements for Data integrity Ø What factors to consider before establishing a DI plan Ø How does CFR 21 Part 11 requirements translate to data integrity requirements Ø What are the success factors for a DI program Ø How is DI validated Ø Why is part 11 not cited in 483s and Warning letters Ø What is the role of management with executive authority in ensuring data integrity Ø What are the data integrity framework elements Ø What is the Data Integrity Maturity Model and how to establish one for your company AGENDA Assuring Data Integrity in the Life Sciences Industry Course outline: Day One (8:30 AM 4:30 PM) Module 1 Data Integrity: concepts, requirements, definitions, approaches Data, information and knowledge

5 Data types, states and lifecycle Meaning and principles of Data Integrity Different data types their relevance to DI DI dimensions, DI regulations, DI predicate rules and their crosswalk Module 2 Why Data integrity issues occur The principal factors that cause data integrity issues to arise How to proactively control these factors DI framework elements in your enterprise that auditors expect to see Deep dive into Access security and Audit Trail Module 3 How to implement a Data Integrity program in your enterprise Using 5p implementation model: Data Governance and Data Management Top-down approach and Bottoms-up implementation From here to there: The Data Integrity Maturity model Role of Management, Quality, Engineering and IT The DI checklist to assess the DI health of your enterprise Module 4 Getting into the trenches - implementing the Data Integrity program Internal audit areas and checklist to assess State of Health of Data Integrity in your enterprise The essential components of your Data Integrity Assurance Plan The must have SOPs for Data Integrity and their contents Providing company guidance on how to validate Data Integrity Day Two (8:30 AM 4:30 PM) Module 5 Data Integrity in the Laboratory Why is laboratory Data Integrity the key focus of all regulatory audits Laboratory Data Integrity audit trend and what is needed to avoid citations Core documentation that you must have to demonstrate laboratory Data Integrity

6 Module 6 Data Integrity in Manufacturing Automation systems Data Integrity impact due to the architecture of a manufacturing automation IT system What data integrity items to review for during a Electronic Batch review DI citations for manufacturing automation IT systems and how to address them proactively DI susceptibilities of hybrid systems commonly found in manufacturing IT systems Module 7 Clinical Trials Data Integrity Specific data integrity issues for clinical trial computer data Paper and ecrf source data entry practices to reduce data integrity vulnerabilities DI risks when generating electronic records which are true copies of paper records Module 8 How is Data Integrity audited How should you mirror your internal audits to regulatory agency audits FDA s new approaches to data integrity audits Audit trends from 483s and Warning letters on DI How to effectively respond to Data Integrity 483 and Warning letters