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COURSE ID 2094

GMPs for Dietary Supplements

AVAILABLE Live
07/24/2023 - 07/26/2023
12:30pm - 5:00pm
12 Hours

Live Online

Early-bird Offer

Limited availability
until July 4, 2023.

$ 2130
Price
$ 2330
Register

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Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

Learn more

Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 1.2 IACET RAPS
View Course Outline

This course will benefit all professionals involved with the manufacture, supply, testing, holding or distribution of dietary supplements whether they be the owner, vendor, manufacturer, or consultant. Individuals from the following areas will particularly benefit from this course:
– Quality Control/Assurance
– Regulatory Affairs
– Laboratory Operations
– Auditing of in-house and contract laboratories
– Management
– Labeling
– Manufacturing
– Supplying and distribution of dietary supplements

who should
attend?

LEVEL
Introductory
INTERESTS
Cosmetics / Personal Care & Skin Care Food Science & Technology Pharmaceutical Science & Technology

Dietary Supplement cGMPs became the law in June 2007. After more than 10 years, the numbers of FDA citations, product recalls, warning letters and injunctions are still at an all-time high.
This course is designed to address that situation. We include full coverage of the requirements. We will use samples of proper SOPs and documentation, case studies and interactive participation to assist the learning experience.
Because of a consumer’s ease of access to dietary supplements and evidence of a lack of understanding by and distributors of their required GMPs, the FDA has stepped up taking regulatory actions against deficient dietary supplement producers. FDA inspections are finding unacceptable compliance and adulterated products that have the potential to actually harm consumers. FDA will continue these actions, including pursuing legal injunctions and product recalls until companies make necessary improvements.
This 12-hour accredited training will cover regulatory and legal aspects of GMP’s for dietary supplements. It will provide a comprehensive introduction and a “how to” program for implementation. Participants will understand issues involved in manufacturing and testing of dietary supplements. They will become familiar with FDA expectations when performing audits of dietary supplement companies. A rational approach to setting up manufacturing and improving a GMP compliant operation will be presented. The latest information available from FDA will be included.

course instructor

Joy Joseph
President, Joys Quality Management Systems

Joy Joseph’s Courses
Joy Joseph is President of Joys Quality Management Systems, a consulting firm serving Dietary Supplement firms through training and implementation of the new cGMPs. She has more than 40 years experience in Quality Control Systems, Regulatory Affairs, Product Development, Manufacturing, and Scientific Affairs in the Pharmaceutical, Dietary Supplement and Cosmetic industries. Ms. Joseph received her B.S. in Chemistry from Xavier University and an MBA from the University of Phoenix. She is a member of the USP Expert Committee of Revisions, setting standards for Dietary Supplements. She has served the USP on various committees since 1990. She is a charter member for the American Association of Pharmaceutical Sciences, a member of the Counsel for Responsible Nutrition (CRN) Regulatory Affairs Committee, and serves on several Scientific Advisory Boards, including the University of California, School of Pharmacy. Ms. Joseph also serves as an advisor and contributor to Tablet and Capsule trade journal and has authored two book chapters, (1) Regulation and Quality Issues Worldwide for Regulation of Functional Foods and Nutraceuticals: A Global Perspective and (2) Formulation Challenges; Multiple Vitamin and Mineral Dosage Forms, published in Pharmaceutical Dosage Forms: Tablets, Third Edition. She is an ASQ-Certified Auditor and Lead Trainer 21CFR Part 117 (New FSMA Regulations). Working with the CRN, Ms. Joseph played a key role in drafting the original GMP guidelines submitted to FDA, for which she was awarded the The Steuben Apple Award in 2005.

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