Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

Duration: 90 Minutes
In the last 4 years the number of FDA warning letter to manufactures of dietary supplement manufacturers have seen a significant increase. Since the implementation of the GMP regulation of dietary supplements in 2007, FDA has conducted numerous audits of manufacturers and suppliers of these products and taken several enforcement actions against products of sub-standard quality, adulterated, false-advertised, or misleading products. To add to that, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.
Dietary Supplement GMP
Instructor: Mukesh Kumar
Product ID: 500294

Most of non-US manufacturing facilities have never been inspected by the FDA or any other regulatory authority. A recent GAO undercover investigation found that many supplements contain heavy metals including lead, mercury, cadmium and arsenic. An earlier report by the Institute of Medicine raised similar concerns. These reports have led to calls of increasing supervision by the FDA.

To address these issues, FDA now requires manufacturers of dietary supplements to follow GMP requirements closer to those for drugs than those for foods. These requirements include stricter documentation, standardized processes, use of trained personnel, adequately designed facilities, quality testing, packaging and shipping, and audit trails of processes. These requirements have created lots of anxiety in an industry filled with small businesses with few products, and international companies marketing in the US.

Why Should you Attend:
Compliance techniques can be simple and implemented with relative ease leading to better products both in terms of quality and potential benefit to consumers leading to better acceptance. If you are a manufacturer, importer, supplier, stocker, marketer, shipper, or user of dietary supplements, this seminar will describe the US GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. This seminar will discuss ways to demonstrate compliance to the current regulations and regulatory trends for the near future. Common findings and possible solutions will be discussed. Case studies will be presented for audit experiences in many countries including US, China, Israel, Taiwan and India.

Learning Objectives:
Learn how to be compliant with current GMP requirements in the US for dietary supplements in less than an hour to increase credibility of existing products and make it easier to launch more products in the US market in the near future.

Objectives of the Presentation:
  • Key manufacturing issues related to dietary supplements and nutraceuticals
  • Raw material sourcing, validation, accountability, and documentation techniques
  • Facility design and planning issues
  • SOP and training requirements
  • How do these changes impact products currently in the market
  • Techniques to ensure compliance at international manufacturing sites
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Manufacturers and marketers of dietary supplements
  • QA/QC/Compliance/Regulatory affairs professionals
  • Regulatory and quality professionals working in companies involved in manufacture and sale of dietary supplement, nutraceuticals and similar products
  • Regulatory and quality professionals working for US companies that are considering the purchase of such products manufactured in non-US markets or vice versa
  • Regulatory, compliance and quality professionals consulting with companies developing such products for the US market
  • Business professionals looking to understand the risks and benefits of investing in such products
  • Senior management of such companies in India, China, Africa and Latin America considering marketing their dietary, nutraceutical and similar products in the US
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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