IPEC-Americas Consultant Irwin Silverstein, Ph.D., provides indepth inforamation about regulatory guidelines for commonly used inactive ingredients in the following FDA regulated products: cosmetics, food, dietary supplements, and pharmaceuticals. Such ingredients must be manufactured under an appropriate Good Manufacturing Practices quality management system. Also, the ingredients must be "approved" or “allowed” in these products. This presentation will provide an overview of the regulatory requirements and a comparison of the GMP expectations for inactive ingredients in these products.
Who should attend? Personnel from regulatory, quality, R&D, and manufacturing areas would benefit from attending this webinar.
Attendees will be able to:
- Differentiate between the FDA requirements for inactive ingredients used in various regulated products; pharmaceuticals, dietary supplements, food, and cosmetics
- Know where to find which inactive ingredients have been previously used and/or approved for use in different FDA regulated products
- Recognize the significant differences in GMP requirements for inactive ingredients in the various regulated products
- Understand GMP quality management system requirements for inactive ingredients marketed for use in multiple FDA regulated products
Katherine Ulman recently retired from Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, after more than 40 years of employment. There she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. She is currently an active advisor for the Regulatory Committee for IPEC-Americas. Ulman earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology.
Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His consulting also includes conformance assessments to site requirements for pharmaceutical manufacturers (finished drug makers). He performs gap analyses with respect to excipient GMP compliance for excipient manufacturers and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. He is an American Society for Quality (ASQ) Certified Quality Auditor (CQA) as well as ISO 9000 Certified Lead Auditor. He helped develop the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin also serves as leader of the IPEC-Americas Excipient Learning Lab (ELL).
Luke Grocholl earned a Ph.D. in inorganic chemistry from the University of North Dakota followed by post-doctoral research in materials science at the University of Iowa. Joined Sigma-Aldrich (now MilliporeSigma) in 2002 as product manager for inorganics then moved to promote and market the newly launched materials science portfolio. He has worked in additional roles including analytical scientist and manufacturing supervisor before joining the flavors & fragrances team to lead sales and marketing efforts for flavoring ingredients, food additives, and cosmetic and household raw materials. Luke moved from sales and marketing to the quality team to lead the alignment with food safety modernization act (FSVP) requirement and establish a GFSI (Global Food Safety Initiative) compliant food safety management program. Luke currently serves a role in regulatory management for MilliporeSigma overseeing food ingredients and pharmaceutical excipient regulatory requirements.