Washington, D.C., August 3, 2015—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, and Informa Exhibitions, a leading knowledge provider, will present an industry-wide webinar to help companies achieve full compliance with good manufacturing practices (GMPs). “Mastering the GMP Inspection: Preparation, Management and Response,” will take place Sept. 9 from 2–4 pm Eastern, presenting insights from industry and legal experts.
"CRN is responding to industry stakeholders who have asked for more information on taking their GMP inspection preparation and management to the next level,” said Andrea Wong, Ph.D., vice president, scientific & regulatory affairs, CRN. “Knowing how to host FDA in your facility, determining which personnel should engage with FDA inspectors, and fully understanding your rights and responsibilities during an inspection, are important to help keep things running smoothly for your company when it is time for your FDA inspection.” Dr. Wong also noted that if a company ends up with a Form 483, there are proven strategies to correct observations and avoid a Warning Letter.
GMPs have been mandatory for all dietary supplement manufacturers, from small to large companies, for five years now, since the final stage of implementation in 2010. It’s imperative that companies are fully compliant with these FDA regulations—and the agency has suggested that inspections may get tougher now that companies have had ample time to get up to speed.
Dr. Wong will moderate a panel of experts including: Mike Bradley, director, scientific affairs & nutrition, Perrigo Company of South Carolina; Joy Joseph, president of Joy’s Quality Management Systems, a regulatory consulting firm; and Greer Lautrup, partner, Sidley Austin LLP. An additional speaker will be announced, as well.
The registration fee for the webinar—$149 for CRN members and $199 for non-members—is a per registration site fee. 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. Additional details and registration information are available at: www.crnusa.org/webinars-informa/GMPmaster.