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: $300.00
Related Trainings
GMPs for Dietary Supplements: 21 CFR 111 Subparts B, C and D
This self-paced course provides specific guidance on protecting dietary supplement products from contamination and adulteration during the manufacturing process.
GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J
This self-paced course covers the requirements for specifications and guidance to establish them, which must be in place to ensure compliance with 21 CFR 111.
GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
This self-paced course covers the requirements for dietary supplement packaging and labeling systems, applicable even if these are the only operations at your facility.