Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements
Tuesday, February 18, 2014 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
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.
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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.