Food and Dietary Supplement Good Manufacturing Practices

This webinar will provide perspective on how US food and dietary supplement companies

should operate their manufacturing and holding facilities in compliance with FDA GMPs – recent

enforcements trends, current issues and challenges.

Why Should You Attend: The federal regulation of food in the United States began in 1906 with passage of the Pure Food and Drug Act, and the regulatory environment continues to evolve today with advances in food formulation, packaging, processing and ever-increasing attention to food quality and safety. In this highly-regulated arena, it is vitally important for food and dietary supplement companies to ensure their products are made, packed and stored in full compliance with FDA Good Manufacturing Practices. This 90 minute session is designed for food and dietary supplement companies in the US, and is focused on helping those companies understand the breadth and depth of good manufacturing practices to they can adopt these requirements into their manufacturing and holding operations. Functional groups that have regulatory, legal, quality assurance, product supply, manufacturing operation (processing and packaging), laboratory operation (analytical, microbiology), or holding & distribution responsibility will benefit from the information shared in this webinar. At the end of this webinar, the speaker will handle your specific questions related to the topic. Areas Covered in the Webinar:

Statutory and regulatory history of Good Manufacturing Practices (GMPs) Review of GMPs.

o Food GMPs in 21 CFR Part 110 o Dietary Supplement GMPs in 21 CFR Part 111 o Key differences between Food and Dietary Supplement GMPs

Implementation of GMPs. o Which entities do they apply to? o Translation of GMPs into SOPs

Current trends and new developments. o FDA enforcement activity o Key watch-outs o Food Safety Modernization Act

Related food safety standards. o HACCP and ISO 22000

Audit readiness o Ownership & accountability

o Documentation

Who Will Benefit:

Regulatory affairs Quality Assurance Product Development Product Supply Laboratory operations

1. Analytical 2. Microbiology

Manufacturing operations 1. Processing 2. Packaging

Distribution & holding operations Legal Internal Auditors Risk Management