The Natural Products Association (NPA) presents a two-part webinar on the Food and Drug Administration’s (FDA) Good Manufacturing Practices (GMP) Rule [21 CFR 111] on April 24 and May 1 from 1 to 3 p.m. Eastern. Participants will hear from the FDA and industry experts on how they can protect their company from an FDA warning letter—or worse. More details, pricing and registration at NPAinfo.org/GMPwebinar.
The FDA has ramped up its GMP inspections, which have resulted in numerous enforcement actions including warning letters, and even recently issued an injunction shutting down a dietary supplement company pending re-inspection for GMPs. This webinar is vitally important for anyone whose job requires an understanding of the GMP rule for dietary supplements, as well as the FDA’s enforcement agenda this year. This includes senior management, regulatory affairs staff and QA/QC, and production and laboratory personnel.
As the first in the industry to offer dietary supplement GMP education, NPA has had more than 1,000 participants from more than 600 companies attending GMP education sessions across the country since 1999. This is NPA’s first webinar about the FDA’s GMP rule since it was published in 2007. NPA also will offer a DVD of the webinar for sale.
Highlights and agenda for the webinar include:
April 24: Day 1
- Industry insights on FDA enforcement activities
- FDA update by special guest Dr. Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs
- Common areas of non-compliance and what to do about them
At the end of day 1, participants will have a better understanding of FDA’s priorities, recent inspection findings, non-compliance trends and what to do about them, and how to interact with FDA during an inspection and avoid getting a warning letter.
May 1: Day 2
- Business models and GMP agreements
- Qualifying suppliers, contract manufacturers and contract laboratories
- Summary and Q&A
At the end of day 2, participants will know more about their GMP-related responsibilities for various industry business models and the important components of strong GMP agreements to avoid gaps in GMP compliance. Additionally, they will learn how to qualify suppliers, contract manufacturers and contract laboratories.
NPA’s presenters include Cindy Beehner, president of QSD Consulting, Aaron Secrist, quality and regulatory manager at NOW Foods, and Dr. Cara Welch, vice president of scientific and regulatory affairs for NPA. These industry experts have worked with hundreds of firms of all sizes. They have more than 35 years combined experience in the industry addressing FDA regulations, especially in the area of GMP and dietary supplements.
NPA also launched a GMP certification program in 1999, the first third-party GMP certification program for the manufacturing of dietary supplements and ingredients. More than 95 companies have achieved certification. For certification details, visit NPAinfo.org/GMP.