October 4-5, 2015
Supply Side West
Las Vegas, Nevada
The WHO WHAT WHERE WHEN WHY & HOW of Dietary Supplement cGMPs - 21 CFR 111 has been in the dietary supplement regulatory forefront for the last three years and it will remain there through 2014. In FY 2013, FDA conducted over 500 inspections of dietary supplement companies. Unfortunately, approximately 70 percent of these inspections resulted in either FDA 483 observations or warning letters, or worse.
NPA’s comprehensive GMP training course covers some of the more complex GMP issues and provides tips for compliance. Dr. Fabricant will stop by to share a few of his biggest takeaways from his more than three years serving as the director of the U.S. Food and Drug Administration's (FDA) division of dietary supplements, and his insight into what's in store for the industry and how it can get where it needs to go. Industry expert presenters Aaron Secrist, NOW Foods’ Director of Quality and R&D, and Brian Frisby, 21st Century HealthCare's Vice President of Regulatory and Quality Compliance, will present in-depth discussion of the cGMP requirements with an emphasis on those areas that are continuing to show up in warning letters and includes activities and case studies to demonstrate the practical application of the material.
NPA is the leader in dietary supplement GMPs and regulatory education, launching the industry's first GMP third-party certification program in 1999 and has since provided the highest quality of dietary supplement GMP education to more than 1,000 attendees over 15 years.
These courses are relevant and valuable for anyone whose job requires an understanding of the FDA labeling and GMP rules for dietary supplements, including senior management and regulatory affairs, QA/QC, production, and laboratory personnel.