About this course
These guidelines are intended to be applicable to dietary supplements as defined and covered by the United States Food and Drug Administration’s Code of Federal Regulations Title 21, Part 111 [Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements] also known as 21 CFR Part 111, but may also be applied to dietary ingredients and other components. This course provides an in-depth review of the guidelines and provides case-studies involving the review of recent Warning Letters initiated to Dietary Supplement companies for non-compliance to 21 CFR 111 GMPs.
Who Should Attend
- Quality and Technical Professionals from a variety of QA/QC, Manufacturing, Engineering, Regulatory Affairs and Compliance, Laboratory and other key personnel.
- As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. A Certificate of Attendance will be provided upon completion of the course.
How to Book
To book this course, please, do not go through the book now on the right of the screen – follow this link instead:
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Course outline
What You Will Learn
- Comprehensive review of the regulations providing a thorough understanding of each subpart relevant to a company’s operations
- Interpretation of each subpart, providing an understanding of how to apply the principles to an employee or company’s specific situation
- Examples of real-world scenarios highlighting areas in which dietary supplement companies’ operations were compliant vs. non-compliant with the regulations
- Thorough review of some of the recent FDA Warning letters submitted to dietary supplement companies and evaluation of their non-conformances with the regulations
- Learn through discussion from other course attendees on best practices and how to address challenging quality issues
- Provides a comprehensive introduction to the GMPs for new personnel or fulfills the need as refresher training to those in QA/QC, manufacturing, production, or R&D seeking to meet a GMP training requirement
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
Venue
New York
SupplySide MarketPlace – New York City
Jarvis Center
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
What you've said
“NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”
Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)
“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”
Kim Randall Pearson, General Counsel, Thorne Research, Inc.
An NSF International Company