2014 - Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

Instructor: Mukesh Kumar
Description:
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.
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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Online Compliance Panel LLC
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California 94536, USA
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