GAMP® 5: End-User Applications

Ever wonder whether your spreadsheet or other desktop application requires validation? This webinar helps you find out by providing deeper understanding for compliant end-user applications and the GAMP 5 Special Interest Appendices. At the conclusion of this session, participants will be able to:

  • Understand “What is an end-user system?”
  • Understand risks related to end-user systems
  • Understand the risk management approach
  • Understand the modified use of the GAMP categories
  • Understand approaches to compliance

Randy Perez currently holds the position of Director, Information Governance and Management for Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He serves on several global Novartis teams dealing with computer systems compliance issues, and has authored many of the firm's global GxP compliance policies. During his over 30 year tenure at Novartis, he has developed a broad range of experience. Prior to his current position he worked as a chemistry group leader in process research, managed a chemical manufacturing process validation initiative, and ran both a GMP training program and a QA validation group for pharmaceutical operations.

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® Council since 2002. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5, published in 2008. Dr. Perez has been a speaker and a course leader at numerous conferences in the US and Europe, and has been published in industry journals and textbooks. In 2005 he was elected to the ISPE International Board of Directors, and served as ISPE Chairman in 2011-2012. He is currently the Chair of the GAMP COP.

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