FDA’s National Expert on Dietary Supplements Discusses the Five Pillars of a Compliant Dietary Supplement Quality System (21 CFR Part 111)
Drawing from FDA inspection trends and enforcement history, this one-hour webinar will be led by FDA’s National Expert on Dietary Supplements, Siobhan Gallagher Taylor. She will provide a practical and regulatory-focused discussion on the foundational elements that the U.S. Food and Drug Administration considers central to dietary supplement quality: specifications, testing, batch production records, master manufacturing records and quality control activities.
Join this webinar to:
– Understand FDA’s definition of quality systems and how the preamble in the federal regulations describes the five pillars as interconnected and essential to compliance and product quality.
– Learn why these areas remain FDA’s top inspectional citations year after year (15 years now of this same trend in citations), including discussion of common compliance gaps.
– Gain practical guidance on where to find FDA’s expectations for implementing compliant systems.
– Strengthen your inspection readiness and quality systems thinking by understanding how FDA evaluates the overall effectiveness of a dietary supplement firm’s quality system during inspections and enforcement actions.
Webinar Agenda
1:00 p.m. – 1:45 p.m. Eastern
Siobhan Gallagher Taylor, FDA’s National Expert on Dietary Supplements in the Office of Human Food Inspectorate, presents on FDA’s cGMPs (current good manufacturing practices) in 21 CFR Part 111.
1:45 p.m. – 2:00 p.m. Eastern
Q&A with Ms. Taylor, moderated by NPA VP of regulatory affairs and communications, Josh Long.
Price:
NPA Members: FREE
Non-Members: $100
