PHOENIX and WASHINGTON—VIRGO and the Council for Responsible Nutrition (CRN) and announced details for an industry-wide webinar to examine key elements of good manufacturing practices (GMPs) for dietary supplements and offer advice as to what industry can do to improve its record of inspections. The webinar will be held on Wed., Jan. 18, 2012, 2:00 to 4:00 p.m. EST. Click here to register.
Moderated by Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN, the webinar will provide attendees with a better understanding of how to increase the likelihood of a successful GMP inspection. The final rule for supplement-specific GMPs was released in June 2007, and was gradually phased-in in three waves, starting with large companies and concluding last summer with the final phase-in of small companies. Although the majority of companies are passing FDA inspection, many companies that are being flagged for not following all the rules. This webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing FDA inspections.
A panel will include FDA representatives; Joy Joseph, president and founder, Joys Quality Management Systems; and Nicki Jacobs; president, 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 records. 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 or 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 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 registration fee—$149 for CRN members and $199 for non-members—is a per registration site fee, meaning multiple people may participate in the webinar from a single site, such as a company’s conference room. This fee also includes unlimited access to the on-demand recording of the webinar for 90 days. A promotional discount of $25 will be offered to participants who also purchased the CRN/VIRGO webinar on the NDI Draft Guidance, held on Sept. 14, 2011.
These webinars mark a continuation of a webinar partnership between CRN and VIRGO that began in 2007.
