The pharmaceutical industry is responding to the challenge of significantly improving the way drug development and manufacturing is managed. New concepts are being developed and applied, including science-based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concepts. Many of these ideas are defined and described in the FDA 21st Century Initiative, new ICH documents such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, ISPE's Product Quality Lifecycle Implementation® (PQLI®) initiative, and various supporting industry consensus standards, such as the ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. GAMP guidance must evolve to meet the needs of the changing environment, and integrate fully with ISPE initiatives such as PQLI. At the conclusion of this session, participants will be able to:
- Understand the recent developments in ICH Guidances, PQLI, and ASTM E2500
- Understand how GAMP 5 is harmonized with these developments
- Apply GAMP 5 key concepts in support of industry objectives
Bruce Davis, Principal, Global Consulting is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. Davis has been a member of ISPE since 1991, and is a member of the United Kingdom Affiliate. He has held the position of Chair of ISPE International Board of Directors and has been active in supporting ISPE, including leading the team writing the original Sterile Baseline® Guide and its current update. He also led ISPE’s case study for practical implementation of Quality by Design (QbD) and is currently co-chairing the team updating ISPE’s Technology Transfer Guide. Davis also facilitated the change to qualification to enable science and risk based principles to be adopted. Previous experience includes the position of past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards and leading the team that set up a distance-learning course, for a UK university, involving some 40 webinars.
Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11, and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He is lead GAMP and Computer Systems Validation and Compliance, Part 11, and Data Integrity trainer and course developer for ISPE. He has extensive experience in all aspects of computer systems validation and compliance, including validation planning, specification and testing of systems, quality risk management, performing site and system compliance audits, performing risk assessments, writing policies and procedures, performing 21 CFR Part 11 assessments, Data Integrity assessments, and supplier audits. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry. He also received the 2016 ISPE UK Fellow Award.