Join us after the 2019 ISPE Annual Meeting & Expo as we take a deeper dive into critical areas of pharmaceutical manufacturing.
This Classroom training course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.
This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management, GAMP® categories, the role of the supplier, and the selection of appropriate specification and verification activities.
Dr. Perez retired at the end of 2015 from the position of Director, Information Governance and Management for Novartis Pharmaceuticals. His responsibilities at Novartis included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He served on several global Novartis teams dealing with computer systems compliance issues, and authored many of the firm's global GxP compliance policies. During his 32-year tenure at Novartis, he developed a broad range of experience. r. Perez was a member of the PhRMA Computer Systems Validation Committee from 1995-1999, and was instrumental in the formation of GAMP Americas when that group started in 2000. From 2002-2008 he was Chairman of GAMP Americas and he has been a member of the global GAMP® Steering Committee since 2002, chairing it from 2012-2015. He was part of the core team that led the development of GAMP® 5, published in 2008. In addition, he initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and he led the team that developed the second edition of this guide that was published in 2017. He was the lead author of the 2014 GAMP® GPG “A Risk-Based Approach to Regulated Mobile Apps,” and was part of the core author team for the 2017 “ISPE/GAMP Guide to Record and Data Integrity.”
This highly interactive classroom course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems.
The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement. This course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.
Mike Byrd, the Director of Computer System Validation (CSV) for ProPharma Group has over 25 years in the pharmaceutical and biotechnology industries, and over 30 years of information systems experience. Mike’s educational credentials include a Bachelor of Science in Chemistry and a Master’s in Business Administration with an emphasis in Technology Management. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes. These included systems supporting automation and control on the shop floor; laboratory automation, data acquisition, and information management; quality workflow management; manufacturing execution; distribution; shipping; enterprise resource planning, interfaces for cross system integration and IT infrastructure supporting a diverse technical computing environment. He has held numerous individual contributor and management roles in his career, many of which have involved forming and managing cross-functional system project teams.
The implementation of Quality by Design (QbD) and Six Sigma within the pharmaceutical industry has led to an emphasis on the importance of companies developing a robust operational control strategy (OCS) to drive the management of product manufacturing processes. This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters. Many activities and exercises will be used to demonstrate the application of First Principles to problem-solving in pharmaceutical manufacturing and engineering. A detailed process for implementing the First Principle approach will be presented, including an example of a complete application of this process.
Bernard McGarvey Ph. D., retired as an engineering fellow at Eli Lilly and Company at the end of 2017. He has a B.E. and Ph.D. in Chemical Engineering from University College Dublin, Ireland. He spent 34 years working for Eli Lilly and Company at various locations in Ireland and the USA. He has held a variety of roles in process control and process engineering over this time, as well as time in corporate manufacturing. His main interest is in the application of First Principles thinking to improve engineering decision making and problem solving at Eli Lilly, covering both process development and manufacturing. Towards the end of his career he has applied this approach to pharmaceutical cold chain distribution leading to improvements in both the speed and quality of decision making in this area.