Dietary Supplement GMPs Overview: 21 CFR 111 and Subparts A, P, H and I

About This Course

This self-paced course provides a brief historical review of regulations in the dietary supplement industry and their evolution as key incidents exposed health and safety risks to the consumer. This eLearning also covers the following subparts of 21 CFR 111, which create the foundation of your quality management system (QMS) and the Good Manufacturing Practices that control product quality:

  • Subpart A: General Provisions
  • Subpart P: Records and Recordkeeping
  • Subpart H: Master Manufacturing Records
  • Subpart I: Batch Production Record

Key Learning Objectives

By the end of this course, you will gain knowledge of:

  • Why cGMPs are important and necessary
  • The difference between prescriptive and performance-based regulations
  • The importance of dietary supplements and where they can be found
  • How the manufacturing process determines product quality
  • The written procedures, documents and records required to be compliant with the requirements of 21 CFR 111 subparts A, P, H and I
  • The importance of maintaining records and how they provide evidence that dietary supplement products are not adulterated
  • The required components of master manufacturing records and batch production records

Pricing: $499.00