Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

Why Should You Attend:

Do you have responsibility the manufacturing or distribution of a dietary supplement, nutraceutical, or food drug? Are you considering launching a product into this rapidly growing market? Do you provide contract manufacturing capabilities for pharmaceuticals and want to learn more about dietary supplement GMP requirements?

If yes, you should consider attending this one-hour webinar which will educate you on the regulatory and quality compliance requirements for these products.

This session will review FDA regulatory requirements, review 21CFR part 111 covering dietary supplements, analyze applicable regulatory guidance documents, and highlight the increasing warning letter trend from FDA for dietary supplement manufacturers.

Learning Objective:

At the end of this webinar, participants will understand regulatory and quality compliance requirements for dietary supplements (often called food drugs, nutraceuticals, etc.)

Areas Covered in the Webinar:

• Review of FDA regulations in this area.
• History of Dietary Supplement Health and Education Act.
• Review 21CFR part 111 requirements.
• Review applicable FDA guidance documents.
• Overview the key elements of the quality system dietary supplement companies should implement to be GMP compliant.
• Analysis of Warning Letter trends among dietary supplement manufacturers.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Companies who sell, distribute or manufacture dietary supplements
• Contract manufacturers
• Quality compliance specialists
• GMP auditors
• Regulatory affairs
• Senior management and business owners

Instructor Profile:

Gretchen Miller Bowker, serves as Chief Operating Officer for Pearl Pathways and has over 25 years experience in the development of drugs, biologics and devices. She is a recognized leader in regulatory, bioethics, and compliance. She has extensive experience in working in an academic research setting, large pharmaceutical companies, small biotech’s, and large device companies. Gretchen spent over 15 years of her career in large sponsor company environments working at both Eli Lilly and Roche Diagnostics (formerly Boehringer Mannheim). She also has real world small start up experience having led the regulatory, quality compliance and clinical teams at a small biotech startup. Throughout her career, she has successfully assembled teams of experts, driven organizational growth, developed processes and procedures, and implemented strategic plans, which ensured successful product development of drug, device and diagnostic products.

Prior to co-founding Pearl Pathways, Gretchen served as Director of Regulatory and Compliance Service Delivery at a Midwest consulting company where she served institutions, sponsors, and CROs. Gretchen is an experienced team leader with specific expertise in meeting global regulatory body expectations, clinical development, and regulatory compliance. Her therapeutic expertise spans most all therapeutic categories and device types, and she has specific oncology expertise in myeloma cancer.

At Pearl Pathways Gretchen oversees the company’s commercial IRB Board, oversees all client consulting engagements, and serves as the company’s Quality Director.

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