The Council for Responsible Nutrition (CRN) and VIRGO announced details for an industry-wide webinar titled—Overcoming GMP Challenges: Charting a Path to a Successful GMP Inspection—to be held on Wednesday, June 12, 2:00 – 4:00 p.m. EDT. This is the next webinar in the CRN/VIRGO webinar series on good manufacturing practices (GMPs). The previous webinar (now available on demand) was held in January, and featured FDA officials (including Daniel Fabricant, Ph.D.), who provided an industry-wide GMP report card, and, along with other FDA representatives and respected GMP experts, advised ways that industry can improve inspection results.
This webinar, moderated by Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN, will delve into individual components of the GMP regulation and examine specifically:
· How to properly respond to a Form 483—and avoid a warning letter
· How to build a strong program for qualifying your suppliers
· How to choose a contract lab and avoid GMP non-compliance by identifying and steering clear of "dry labs"
A panel of top regulatory experts—Anthony Celeste, senior advisor, EAS Consulting Group; Edward Wyszumiala, general manager, NSF International; Frank Jaksch, founder and chief scientific officer, ChromaDex; and Darryl Sullivan, director of scientific affairs, Covance Laboratories—will share their hands-on expertise to help companies learn the intricacies involved in being GMP compliant.
“Our last webinar was a frank reminder from FDA that our industry needs to improve its record with regards to GMPs,” said CRN’s Duffy MacKay. “But the GMP regulation is very complex and the inspection process can be a daunting experience for even the most prepared company. This webinar will take participants deeper into the regulation, drilling down into several of the most important components.”
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 taking more than one CRN/VIRGO webinar in 2012.