The Gartner hype cycle & CSA

Thursday,  September 29 | 10:00AM ET

Presented by – Stefan Muench, Business Director Validation, Körber Pharma Consulting

Key Learning Points:
• Technology Trigger: FDA’s case for quality initiative
• Peak of Inflated Expectations: Vaporware
• Trough of Disillusionment: A ghosting guidance
• Slope of Enlightenment: Hide and seek – CSA in G5SE
• Plateau of Productivity: Reserved for future use

Key Takeaways:
• What are the drivers behind CSA?
• How CSA permeated into GAMP® 5 Second Edition
• Understand the impact of CSA on current validation practices


Stefan Muench

Business Director Validation, Körber Pharma Consulting

As Business Director Validation, Stefan Muench is responsible for the Validation Services of Körber Pharma Consulting. He is a computer scientist with long-standing experience in SW development (MES) and as Principal Consultant for the pharmaceutical industry.

Furthermore, for more than 10 years Mr. Muench is a proactive author, speaker, moderator, and trainer for many subjects around SW development, validation, and data integrity. He is an active member of ISPE and the GAMP D-A-CH steering committee.

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