This one-hour eLearning course will focus on the cGMP requirements and other aspects of 21 CFR 117 required for the dietary supplement industry.   Dietary supplement manufacturers may be exempt from the preventative control requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this course, the elements of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers will be highlighted.  Read more

Dietary Supplement companies and raw material suppliers are not exempt from the Foreign Supplier Verification Program (FSVP) requirements outlined in 21 CFR 1 subpart L. There are, however, modified requirements for companies that are following 21 CFR 111. In this one-hour course we will highlight the key requirements of the FSVP for raw material suppliers and dietary supplement companies. You will learn how the FSVP requirements are an extension of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation. Understand what is required for FSVP Know who is considered to be an importer Understand how the requirements are modified for dietary supplements and dietary supplement components Know where the regulations are found Know when an onsite audit may be required Instructor: Jennifer Alfrey Please note a PDF of the presentation will not be distributed. Read more

This course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules, this course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, and investigations; as well as an overview of the relevant subparts. This course also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies the requirements of quality, and describes the purpose of GMP rules, regulations and FDA enforcement. As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Module 1 of this course covers the following requirements of 21 CFR 111: o Subpart A – General Provisions o Subpart P – Records and Record Keeping o Subpart H – Master Manufacturing Records o Subpart I – Batch Production Record Module 2 of this course covers the following requirements of 21 CFR 111: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Module 3 of this course covers the following requirements of 21 CFR 111: o Subpart E – Production and Process Control o Subpart K – Manufacturing Process Control o Subpart F – Quality Control o Subpart J – Laboratory Operations Module 4 of this course covers the following requirements of 21 CFR 111: o Subpart G – Components, Packaging, and Label Control o Subpart L – Packaging and Labeling Control System o Subpart M – Holding and Distributing o Subpart N – Returns o Subpart O – Complaints o The Role of the FDA and its Authority Read more