CRN AND VIRGO ANNOUNCE WEBINAR TO EXAMINE GMP COMPLIANCE

—FDA Representatives and Industry Experts to Review
Key Elements of Successful Inspections—

WASHINGTON, D.C., December 20, 2011—In light of recent FDA comments as to why so many companies are failing GMP inspections, the Council for Responsible Nutrition (CRN) and VIRGO today 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 Wednesday, January 18, 2012, 2:00-4:00 p.m. EST.

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, there are still too 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 Food and Drug Administration (FDA) representatives (specific speakers to be announced in January) and other regulatory experts (Joy Joseph, president and founder, Joys Quality Management Systems; 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.  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. 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,” said Dr. MacKay.  

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 September 14, 2011.

These webinars mark a continuation of a webinar partnership between CRN and VIRGO that began in 2007.  To find further details on the speakers, the agenda, and registration information, please visit Natural Products INSIDER or www.crnusa.org.

Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers.  In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our 75+ manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as CRN’s Code of Ethics. Visit www.crnusa.org.