Tuesday, November 10, 8am–5pm & Wednesday, November 11, 8am-12pm
Location: Congress Center, Galileo 1006, Level 1
It’s been one and a half years since the publication of the U.S. Food and Drug Administration’s (FDA) good manufacturing practices (GMP) rule for dietary supplements. This important regulation establishes new stringent requirements for companies involved with the manufacturing, packaging, labeling and holding of dietary supplements. The FDA has started GMP inspections for companies with more than 500 FTE employees and will begin GMP inspections for companies with 20 or more FTE employees beginning July 2009. To help the industry understand the requirements, address compliance to the new rule, and prepare for eventual regulatory inspections under the FDA GMPs, Virgo Publishing and the Natural Products Association are offering an one and half day educational seminar event to discuss the impact and provisions of the final rule. Over 1,000 industry representatives have attended this popular seminar, exploring the challenges of the new regulation and gaining valuable insight on addressing compliance to the FDA GMPs.
Seminar presenters include:
Cindy Beehner, President, Quality Design Systems/C. Beehner Consulting
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.
This course is designed for companies with a good understanding of current industry GMPs and will be relevant and valuable 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.
The seminar agenda will include:
• 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
• Qualifying your suppliers and other vendors to ensure quality and consistency in meeting GMP compliance
• Qualifying certificates of analysis to allow for reduced testing of components
• Third-party certification
• How to handle visits from the FDA and discussion of FDA expectations based on recent FDA GMP
inspections
• 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
