Dietary supplement manufacturers may be exempt for the preventative controls requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this one hour webinar we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what new cGMP requirements found in subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111. This webinar will help you learn how to determine which parts of 21 CFR 117 apply to dietary supplement manufacturers and to raw material suppliers. Instructor: Jennifer Alfrey A PDF of the presentation will not be not be distributed for this recording.   Read more

Food defense is a new area of compliance for the food industry which includes dietary supplement manufacturers. In this one-hour course we will cover the aspects of 21 CFR 121 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what a food defense plan is and what is meant by intentional adulteration. • Understand what a food defense plan is • Know where to find the new regulations • Understand how to perform a vulnerability assessment • Understand how intentional adulteration in the dietary supplement industry is covered under the food defense regulation • Know how this new regulation in 21 CFR 121 impacts Dietary Supplement Manufacturers and raw material suppliers. Please note PDF's of the presentation will not be available. Read more

This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: Take part in a collaborative online training developed to streamline the MMR development processes, focusing on: The difference between an MMR and a BPR The regulatory requirements for MMRs for dietary supplements FDA requirements for BPRs Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs. Learn best practices to simplify and improve your internal operations - enabling your batch records to withstand audits and inspections. Full Training agenda: • The regulatory requirements for MMRs for dietary supplements • The difference between an MMR and a BPR • FDA requirements for BPRs • Citations from recent Warning Letters • Creation and use of the Batch Production Record • Examples of best (and less-than-best) practices • Tips to improve your company’s MMRs and BPRs   Read more

This course provides a basic understanding of cleaning and sanitation for dietary supplement facilities. Participants will learn the importance of sanitary facility design, how to build contamination prevention mitigation into the construction of the plant, and how to write a compliant environmental monitoring plan. You will learn what SOPs are required for general facility cleaning and sanitation. At the conclusion of this training, participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program. At the conclusion of this training participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program: • Discuss relevant terminologies • Review Personnel hygiene and training requirements • Discuss Facility cleaning and sanitizing • Latest advice from the CDC and WHO • Contamination prevention mitigation • Environmental monitoring • Development of Cleaning & Sanitizing Methods Please note there are two recordings for this session. Instructor: Norm Howe A PDF of the presentation will not be not be distributed for this recording. Read more

The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Introduction to Product Labeling for Dietary Supplement”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation, how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement. Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance, enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification. Instructor: Erin Taraborrelli Note: A PDF of the presentation will not be distributed for this recording. 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