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

Why Should You Attend:

In the last 4 years the number of FDA warning letters to manufactures of dietary supplement manufacturers have seen a significant increase. 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.

If you are a manufacturer, importer, supplier, stocker, marketer, shipper, or user of dietary supplements, this training is for you. The webinar will describe the US GMP requirements and discuss techniques to be compliant using easier, shorter and convenient strategies. The presenter 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.

Areas Covered in the Seminar:

• 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.

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.

Who Will 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

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

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. 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.

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