In the last 4 years the number of FDA warning letter to manufacturers 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. 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.
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. 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, join Dr. Mukesh Kumar in this riveting session, where he will describe the US GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. He will discuss ways to demonstrate compliance to the current regulations and regulatory trends for the near future. Mukesh will also cover the common findings and possible solutions. Plus, he will present case studies for audit experiences in many countries including US, China, Israel, Taiwan, and India.
Topics to be covered:
Who should attend?
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). 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...
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