NPA GMP Seminars
What You Need to Know: How the FDA GMP Rule for Dietary Supplements Applies to You
The WHO WHAT WHERE WHEN WHY & HOW of Dietary Supplement cGMPs
NEXT GMP SEMINARS:
Expo East – Balimore, Md.: September 25-26, 8 a.m.-5 p.m.
Located Close to an Industry Supply Show – Las Vegas: November 12-13, 8 a.m.-5 p.m.
SOHO Expo, Orlando, Fla.: December 5-6, 8 a.m.-5 p.m.
FDA has published warning letters for violations related to dietary supplement GMPs! Learn how to avoid this happening to your company.
It’s more important than ever to understand the cGMP requirements as they apply to your company. 21 CFR 111 has been in the dietary supplement regulatory forefront for the last two years and it will remain there through 2013. In FY 2012, FDA conducted more than 370 inspections of dietary supplement companies. Unfortunately, about 70 percent of these inspections resulted in either FDA 483 observations or warning letters, or worse. The FDA has expressed concern that they are “finding that the basic tenets of cGMPs, and manufacturing in general, are not being adhered to, or in many instances are completely absent.”
NPA offers a comprehensive training course with expert presenters who cover the complex GMP issues and provide tips for compliance. NPA seminar presenters have many years of experience working with dietary supplement GMPs, and evaluating warning letters and compliance plans to determine the FDA’s expectations. The NPA seminar presents an 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. Additionally, the seminar prepares you for when the FDA knocks on your door. You will leave the seminar understanding what to expect during an inspection, how to respond to interactions with FDA officials, and how to prevent Form 483 observations from escalating into warning letters.
NPA is the leader in dietary supplement GMPs, launching the industry's first GMP third-party certification program in 1999 and providing the first and best dietary supplement GMP education to more than 1,000 attendees in 13 years. The 2013 Program features an agenda that covers the FDA GMP requirements that are proving to be the most complex and challenging, including examples and case studies throughout to illustrate the concepts.
Seminar presenters include: Cindy Beehner, president of QSD Consulting; Aaron Secrist, quality and regulatory manager at NOW Foods; and NPA staff. Beehner and Secrist are industry experts who have worked with hundreds of industry firms of all sizes to help them develop and implement effective quality systems. Between the two of them, they have more than 40 years combined experience working in and consulting with the industry to address FDA regulations, especially in the area of good manufacturing practices and dietary supplements.
This course is relevant and valuable for anyone whose job requires an understanding of the FDA GMP rule for dietary supplements, including senior management and regulatory affairs, QA/QC, production, and laboratory personnel..
New for 2013!
The seminar has been expanded to 2 full days, consisting of 4 half-day sessions – now you can attend the full 2-day seminar, or attend one or more of the half-day sessions individually. Note: each individual session includes practical application activities
- Day One Morning Session: Quality Control, Documentation & Change Control – covers business models, Quality Control, GMP documentation (SOPs, Records & Documented Rationale for each subpart), Change Control
- Day One Afternoon Session: Specifications and Verification Testing – in depth coverage of establishing specifications and verification testing, methods, data integrity, where to find information, qualifying vendors & COAs, GMP agreements, new FSMA information
- Day Two Morning Session: Manufacturing Operations, Deviations and Material Reviews – covers master manufacturing records and batch production records, manufacturing operations, deviations & investigations, material reviews
- Day Two Afternoon Session: Maintaining Compliance and Update on FDA Inspections – covers tips on monitoring and maintaining compliance, using mock recalls, internal audit and investigation trend data to ensure compliance, when to call in an expert, nuts and bolts of a FDA inspection, review of FDA inspectional activities, how to respond to FDA 483s to avoid escalating enforcement action
Register today for the session you wish to attend!
For more information or to register by phone, contact Vicki Whitsitt at (800) 966-6632 ext. 243 or vwhitsitt@NPAinfo.org.
NPA also offers onsite training on GMPs and other regulatory topics. Contact the Scientific and Regulatory Affairs Department for more information and a quote for onsite training.