This training on FDA cGMPs for Dietary Supplements and Nutraceuticals will discuss current FDA regulations, GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. Case studies of FDA audit experiences will be presented for easy understanding.
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.
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
Course Provider
Mukesh Kumar,
