GAMP® 5, FDA CSA, and the Future of Computer Systems Validation Webinar

Extended Learning
Learning Level: Intermediate

Extended Learning Webinars take a 90-minute deeper dive into industry-critical topics you want and need to learn more about. Benefit from in-depth, actionable conversations and extended Q&A time from the audience at the live webinar. 

This webinar discusses new developments in the field of Computer Systems Validation, including US FDA’S Case for Quality initiative and CSA (Computer Software Assurance), GAMP initiatives supporting innovative technologies, and the application of Critical Thinking, Knowledge Management and Organizational Excellence and Maturity. The webinar will also address some of the CSV challenges and problems facing the industry and how we can address them. 

Learning Objectives

  1. Current industry challenges in CSV and how to address them, including concepts from US FDA Case for Quality and CSA  
  2. GAMP support for Case for Quality, and support for the application of effective good practices and innovative technologies 
  3. How critical thinking, knowledge management, cultural excellence and data governance maturity are essential for effective CSV 
technology

Bonus Material: Due to the overwhelming engagement from the live webinar attendees, the speakers received a large amount of questions for the Q&A session.  Since the speakers were not able to answers all of questions during the live webinar, we did create a downloadable document with answers to all of the questions.  Get access to this document with your on demand purchase!

$99 members/$149 nonmembers

Get access to the recording for 1 year.

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Speakers

Sion Wyn
Director
Conformity Ltd.
Heather D. Watson
Director Computer Systems QA
GlaxoSmithKline
Charlie C. Wakeham
APAC GxP Compliance Manager
Waters Corporation
Lorrie L. Vuolo-Schuessler
Senior Director Computer Systems Quality and Data Integrity
Syneos Health