cGMP and HARPC 

Session description:​

This SupplySide Fresh session on legal and regulatory issues is focused on Current Good Manufacturing Practices (cGMPs), which were modernized by FDA in Title 21 of the Code of Federal Regulations (CFR), Part 117. You will learn about cGMP regulations, including requirements for hazard analysis and risk-based preventive controls (HARPC) for human food.

Industry expert
Joy Joseph
President and CEO
JOYS Quality Management Systems LLP

Joy has more than 50 years of experience in quality control systems, regulatory affairs, product development and scientific affairs both in the pharmaceutical and dietary supplement industries. Her expertise extends to professional education and manufacturing management.

Since 1994, Joy has been a member of the United States Pharmacopeia (USP) Expert Committee. She is a charter member for the American Association of Pharmaceutical Sciences, a member of the Counsel for Responsible Nutrition (CRN) Regulatory Affairs Committee and has served on several scientific advisory boards, including the University of California, School of Pharmacy, and the University of Illinois, Chicago. She played a key role in drafting the original Good Manufacturing Practices (GMP) guidelines submitted to FDA for consideration in formulating the final rule for dietary supplements. She is also a board member of the Nutrition Industry Association, the ASQ / FDA Southern California Dietary Supplement Consortium and is a lead instructor for PCQI and FSVP Training under the FSPCA programs.