Webinar: CRN, VIRGO to bridge GMP gap between industry action and FDA expectations
WASHINGTON — The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.
Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration inspections.
In addition to MacKay, the panel will include as-yet-not-announced Food and Drug Administration representatives and other regulatory experts, such as Joy Joseph, president of Joys Quality Management Systems, and Nicki Jacobs, president of Jacobs Compliance Services. These experts will review several key GMP requirements where inspections have demonstrated patterns of deficiency, such as the requirements to establish specifications for raw ingredients, test incoming ingredients, verify contents of finished products and follow master manufacturing. In addition, speakers will touch upon other often overlooked GMP provisions, such as the “umbrella” clauses that are requirements that apply to all the points on the supply chain, including manufacturers, suppliers, transporters and distributors.
“In the three-and-a-half years since the current GMP final rule first went into effect, there has been a disconnect between what companies are doing and what the FDA expects," MacKay said. "The problems are not limited to one size or type of company but have been seen across the board and are, quite frankly, disturbing. Ultimately, unless the industry improves its track record, our industry’s credibility will suffer.”
The webinar will be held Jan. 18.