In April 2018, the FDA set a new precedent by issuing their first ever mandatory recall due to a multi-state outbreak of Salmonellosis. Modern genomics is transforming our understanding of Salmonella biology, and as we learn more about how to assess the risk of Salmonella contamination, detection and prevention methodologies have become modernized to adapt to these new insights. From a GMP standpoint, it is imperative that the dietary supplement industry is up to date with these modern methodologies in order to detect for common micro contamination.
Areas of discussion will include:
- An understanding of FDA expectations for firms to include in their assessment of salmonella contaminations
- Examples of warning letters issued by the FDA regarding GMP matters
- The top part 111 charges issued in warning letters today by FDA
- Best practices in the industry … going above and beyond part 111
- What non-compliant firms are still having trouble with in the dietary supplement cGMPs, according to FDA
- Other parts of the Federal Food, Drug, and Cosmetic Act FDA that will be covered during an FDA inspection (outside part 111 GMPs)
- The challenges today for manufacturer compliance with part 111 GMPs
- How the area of GMP focus changed over the decade since their implementation by FDA 10 years ago
NPA will provide a cadre of 4 speakers, comprised of 2 industry veterans and 2 Federal experts to tackle these and other difficult questions. Come join NPA and its speakers on its look at the past 10 years regarding compliance with part 111 GMPs and other areas of compliance. Bring your questions to ask our panel of experts.
Eric Brown (Food & Drug Administration)
Saleh Turujman (Food & Drug Administration)
Steve Barnes (Nutra Manufacturing Inc.)
Aaron Secrist (NOW Foods)
When: October 30, 2018 1:00 PM – 3:00 PM Eastern Time