1.Caffeine Safety: A Three-Decade Review…and the 2013 Landscape James R. Coughlin, PhD CFS President, Coughlin & Associates Aliso Viejo, California [email protected]…
1. Case StudiesWhat went wrong? 2. Case Study # 1FDA v Schering Plough 3. Lesson 1- don’t ignore the FDA• Schering Plough was audited by the FDAon several occasions and…
GAMP5 and the Alignment to International Guidelines 52 South First Street Suite 320 San Jose, California 95113 P: 408.294.5500 F: 408.294.5507 www.veracord.com…
Slide 1 1 The Pharmaceutical Industry and ICH Q9 Peter H Gough Partner, David Begg Associates Slide 2 2 21 st Century GMP Initiative “Seeks to integrate quality systems…