Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations

Why Should You Attend:

Experience and a clear understanding of the Dietary Supplement cGMP (DS cGMP) regulations are absolute necessities when building or maintaining an FDA compliant dietary supplement company. Having a good foundation in the regulations enables you to be confident in exactly what your responsibilities are in the eyes of the FDA and significantly improves your chances of achieving compliance in the most sustainable and cost-effective way possible. If this seems to be a daunting task and you’re not sure where to start, you will certainly benefit from attending this webinar on the dietary supplement cGMPs.

This webinar will explain cGMP regulations for dietary supplements. In a simple to understand, yet detailed training session, the instructor will present the requirements and key points to provide the solid foundation in DS cGMP regulations you need.

Areas Covered in the Webinar:

• Timeline of the regulation of dietary supplements
• Who is subject to DS cGMP
• Written procedures required by the DS cGMP
• Records required by the DS cGMP
• Organization and overview of the DS cGMP
• Key highlights from the subparts
• Common pitfalls and misunderstandings in the DS cGMPs

Who will benefit:

• Internal Auditors
• Regulators
• Compliance Officers
• QC Managers
• QA Managers
• Quality and Validation Department Staff
• Compliance Consultants
• Senior Management

Instructor Profile:

Jennifer Medlar, has over 10 years’ experience in the areas of quality assurance, quality control, process development, and validation in both industry and consulting roles. She has experience in the biopharmaceutical, pharmaceutical, medical device, cosmetic, dietary supplement, feed additives and industrial product industries.

Prior to Advanced Biomedical Consulting (ABC), LLC, Jennifer worked for Belcher Pharmaceuticals, a contract and proprietary solid and liquid oral dose pharmaceutical manufacturing facility, in increasing roles of responsibility from Quality Control Analyst to Quality Group Leader. Prior to Belcher Pharmaceuticals, Jennifer worked at TSE Industries, as a Chemist and has also worked for the Department of Agriculture as a Quality Control Chemist. In addition, Jennifer has experience in the education field. She taught analytical chemistry at the University of South Florida and has worked for Link-Systems International as a Project Coordinator for the development of online content that accompanies chemistry and other science text books.

Topic Background:

A dietary supplement is a product taken by mouth that is intended to supplement the diet and contains dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Although the common forms (e.g. tablets, capsules, liquids, etc.) that dietary supplements come in resemble the common forms of drugs, the Dietary Supplement Health and Education Act (DSHEA) of 1994 places dietary supplements in a special category under the general umbrella of "foods," not drugs. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. In 2007, FDA published the Dietary Supplement Current Good Manufacturing Practices (DS cGMPs) for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

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