NPA’s newly revamped GMP seminar and its newest regulatory seminar, “Agency Insights: Claims and Other Compliance Issues," will allow attendees to hear regulators and industry experts discuss supplement GMPs and FDA inspections.
NPA’s premier GMP seminar, What You Need to Know Prior to an FDA Dietary Supplement cGMP Inspection, features discussions from FDA insiders and industry experts who address the top GMP problem areas, and it includes activities and case studies to demonstrate the practical application of the material. Attendees will hear from NPA CEO Daniel Fabricant, Ph.D., who previously served as director of the FDA's division of dietary supplement programs, and two FDA dietary supplement officials—Charlotte Christin, the current acting director of the division of dietary supplement programs, and Cara Welch, Ph.D., regulatory special assistant—as well as Gary Coody, FDA’s national health fraud coordinator.
Fabricant will introduce the seminar on Wednesday, Sept. 17, and share a few of his biggest takeaways from his more than three years at the FDA, and his insight into what's in store for the industry and how it can get where it needs to go. Christin and Welch will stop by on the morning of Thursday, Sept. 18, to informally discuss topics such as the direction of the agency on GMP inspections (for example, do they anticipate conducting more, the same or fewer inspections in 2015?), when the new draft NDI guidance will be released, new initiatives the industry can expect to see in the near future, etc. Coody will informally speak about current FDA health fraud initiatives and blitzes, including an update on what the agency is finding, if the scope of initiatives continues to be diabetes, weight loss and hangover products, and if there are any new areas to watch out for.
In addition to the featured speakers, NPA’s GMP seminar will include industry experts Cindy Beehner, president of QSD Consulting, and Aaron Secrist, director of quality assurance/quality control and R&D at NOW Foods, who will present an in-depth discussion of the GMP requirements with an emphasis on those areas that are continuing to show up in warning letters. Corey Hilmas, M.D., Ph.D., NPA's senior vice president of scientific and regulatory affairs, will also be present to answer questions.
Following the GMP seminar, NPA will host a brand new half-day seminar, Agency Insights: Claims and Other Compliance Issues. Attendees can hear from Hilmas, former chief of the dietary supplement regulation implementation branch at FDA; Rich Cleland, FTC’s sssistant director of the division of advertising practices; and Latasha Robinson, FDA’s branch chief for the labeling and dietary supplements compliance branch. Cleland, who also served as special assistant attorney general and director of the division of consumer protection in the Iowa Attorney General's Office, will share some informal comments and insights with attendees on substantiation of product claims, recent actions and the FTC’s requirements for substantiation. Robinson will discuss FDA’s dietary supplement GMP compliance and overall labeling program, and also provide insights into the most serious GMP charges still encountered by the FDA from part 111 inspections.
Hilmas, who trained and advised FDA field and investigators in the FDA GMP course, will cover compliance issues encountered during the dietary supplement GMP inspection. During the interactive seminar, attendees will learn about import GMP metrics, questions they should be prepared to answer during the GMP inspection and what they can expect from FDA investigators. Plus, they will get a birds-eye view of the entire program. In addition, attendees will master the mandatory elements of dietary supplement labels, learn the misbrandings most important to FDA, understand the importance of labels in the dietary supplement GMP inspection, and better prepare for the part 111 GMP inspection.
During both seminars, presenters will discuss hot topics and use hands-on activities, examples and case studies to demonstrate the practical application of the materials.
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, R&D, and laboratory personnel.
The GMP training is offered as a full 1.5-day course or three half-day sessions. For an overview of the most challenging elements to GMP compliance, register for the full seminar. For an overview or refresher on specific topics, attend the session that covers that subject matter. “Agency Insights: Claims and Other Issues" is a half-day session, offered immediately after the GMP seminar and requires a separate registration. Register here, and sign-up for both to save $100 on each seminar for a total savings of $200.