Validation of a pharmaceutical manufacturing process is an essential requirement with respect to compliance with Good manufacturing Practices (GMP) contained within the Code of Federal Regulations (21 CFR). Course covers validation concepts for plant, process, cleaning, sterilization, filtration, analytical methods, and computer systems; GAMP (Good Automated Manufacturing Practice), IEEE SQAP, and new electronic requirements – 21 CFR Part 11. Master validation plan, IQ, OQ, and PQ protocols, and relationships to GMP. National (FDA) and international (EU) regulatory affairs for cGMP (current Good Manufacturing Practice) and cGLP (current Good Laboratory Practice) requirements in development, manufacturing, and marketing. Handling the FDA inspection.