An Advanced Course on the Final FDA GMP Rule for Dietary Supplements
Monday, April 28 from 8am to 5pm
Tuesday, April 29 from 8am to Noon
Presented by
In response to the U.S. Food and Drug Administration’s (FDA) good manufacturing practices (GMP) rule published on June 25, 2007, the Natural Products Association is offering an one and half day educational seminar event to discuss the impact and provisions of the final rule. This important regulation establishes new mandatory requirements for dietary supplement manufacturers and dietary supplement distributors. Learn about what is expected and the consequences of non-compliance.
This course is designed for companies with a good understanding of current industry GMPs and will be relevant for anyone whose job responsibility requires a comprehensive understanding of the FDA GMP rule for dietary supplements, including management, and regulatory affairs, QA/QC, production and laboratory personnel.
Seminar presenters include:
Carl Reynolds, Vice President, EAS consulting
Cindy Beehner, President, Quality Design Systems
Aaron Secrist, Director of Quality, Nature’s Way
Natural Products Association Staff
Seminar presenters have over 75 years combined experience in addressing FDA regulations, especially in the area of good manufacturing practices and dietary supplements. Ms. Beehner and Mr. Reynolds have first-hand experience working with industry to meet the challenges of compliance to the laws and regulations related to dietary ingredients and dietary supplements and Mr. Secrist will present an industry insider’s perspective on meeting the requirements of the new rule.
Agenda:
- Comprehensive discussion of specific FDA GMP requirements including establishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid analytical methods, raw materials and finished product testing requirements, and change control
- Developing GMP-compliant SOPs, master manufacturing and batch production records, and other required documentation
- Working with your suppliers and other vendors to ensure quality and consistency in meeting GMP compliance
- Third-party certification
- How to handle visits from the FDA
- Tips on getting started incorporating new FDA GMP requirements within your company’s current GMP systems
- Opportunity for technical question and answer discussion with industry GMP experts
- Group activities regarding establishing regulatory specifications and developing adequate procedures
Registration:
NATURAL PRODUCTS ASSOCIATION Member* $695
Non-NATURAL PRODUCTS ASSOCIATION Member* $895
*10% discount available to registrants from the same company
To Register:
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