2 Day Seminar Assuring Data Integrity in the Life Science industry. Manufacturers

Transcription

1 2 Day Seminar Assuring Data Integrity in the Life Science industry Manufacturers 12 RAPS CREDITS Location 1: Apr Boston Location 2: Apr San Francisco, CA Seminar One Registration $ Apr, 2017 Boston $ Apr, 2017 San Francisco, CA Special Group Discount Register for Four attendees $ 3495 COURSE SUMMARY An Interative Workshop Presented BY WCS & Chinmoy Roy BSEE MSCS 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. Top 5 companies who have completed the recent Assuring Data Integrity 2 days seminar:

2 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. 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. Learning Objectives What are the recent regulatory changes for Data Integrity What should be the management structure for DI accountability What are the documentation requirements for Data integrity What factors to consider before establishing a DI plan How does CFR 21 Part 11 requirements translate to data integrity requirements What are the success factors for a DI program How is DI validated THE TRAINER

3 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 issua. TRAINING WILL BENEFIT: Pharmaceutical industry / Medical device industry / Healthcare industry personnel Developers of software for use in Life Sciences industry Validation service providers, IT service providers Manufacturing personnel, Manufacturing Automation system vendors and system integrators Regulatory Affairs group, Quality Unit Laboratory personnel Users of Cloud Clinical Trial Sponsors TRAINING TAILORED TO ACHIEVE THE FOLLOWING GOALS:

4 Areas Covered 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 AGENDA DaY ONE (08:30 AM to 04:30 PM) Module 1 Data Integrity: concepts, requirements, definitions, approaches Data, information and knowledge 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

5 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 (08:30 AM to 04:30 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

6 Core documentation that you must have to demonstrate laboratory Data Integrity 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