Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations
Carol DeSain Carol DeSain’s consulting services focus on regulatory compliance for biologic, biotech, pharmaceutical, diagnostic, and combination products. She has worked in the industry for more than 25 years, with start-ups, global corporations, contract manufacturers, and allied industries in the U.S. and Europe. Carol helps her clients establish new systems, re-work failing systems, establish policy for global corporations and train management and staff. She is known for her broad knowledge of the industry, a practical, hands-on approach to compliance, interactive and informative training sessions, and for the books she has co-authored on documentation, risk management, validation and product development. Prior to consulting Carol worked in basic research (biochemistry, enzymology, and genetics), product/process development, and aseptic pharmaceutical manufacturing.