Validation and Regulatory Affairs in Pharmaceutical Manufacturing (PME/ME/CHE540)

An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).