Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This 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.
Dr. 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 GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
Winnie Cappucci retired from the position of Associate Director Product Supply IT Systems Compliance, North America for Bayer HealthCare. She has worked in the pharmaceutical industry for 43 years and in global roles for the last 19 years. Ms. Cappucci has worked as a business process owner, an IT professional and lastly as a quality and compliance specialist in a highly regulated environment. In her last role Ms. Cappucci was responsible for developing and implementing Bayer’s global standards for computerized systems compliance. She is a past member of the ISPE International Board of Directors, Chair of the GAMP Council, member of the GAMP America Steering Committee and the GAMP Editorial Board.
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 years’ experience in the pharmaceutical, biotech, and device industries.