Dietary Supplements and Nutraceuticals: Compliance with FDAâ€™s Current Manufacturing Requirements - (FDA Compliance)
Venue: Online Event
|Event Date/Time: Apr 07, 2011||End Date/Time: Apr 07, 2011|
Recently FDA announced an aggressive campaign to enforce the Good Manufacturing Practices (GMP) regulation on manufacturers and suppliers of dietary supplements in the US. Also, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.
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.
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 webinar will describe the US GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. We 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.
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