CRN To Host Two-Part Virtual Training January 23–24 on GMP Inspections: 'What to Do When the FDA Comes Knocking'

JANUARY 9, 2024

WASHINGTON — CRN (Council for Responsible Nutrition), the leading trade association representing the dietary supplement and functional food industry, in partnership with NSF, will host a two-day virtual training entitled GMP Inspections: “What to Do When the FDA Comes Knocking.” The series begins on Tuesday, Jan. 23, 2024, at 1 p.m. EST, with the first part focusing on an overview of the GMP inspection process and how to prepare for it, followed by the second part entitled “What to Expect During and After the GMP Inspection,” on Wednesday, Jan. 24 at 1 p.m. EST

Since the beginning of the COVID-19 pandemic three years ago, FDA halted routine domestic inspections of manufacturing facilities and is now re-invigorating its on-site program. CRN and NSF are offering this training to assist companies in remaining compliant after this significant period of inspection dormancy. The webinar is intended for anyone working in a supplement manufacturing or distribution facility, legal department personnel, or those who have responsibility for manufacturing, quality and/or regulatory management. For employees who may be new to managing the internal inspections, this will provide a solid orientation of the entire process. It can also serve as a refresher for more senior staff to make sure they have not forgotten any key components, or to ensure that their understanding of the process has not changed since the last inspection. 

Participants can expect to learn the following: 

  • the regulatory intricacies surrounding the GMP inspection process and insights into what takes place during the actual inspection; 

  • the secrets to pre-inspection success, with a focus on the most crucial preparatory steps; 

  • the key elements to managing the inspection process strategically, and how to handle unexpected challenges to ensure optimal outcomes; 

  • the difference between what inspectors can and cannot ask, and how to respond to some of the tricky questions that can arise; 

  • how to prepare your employees to excel during inspector Q&A sessions; and 

  • the essential elements of the post-inspection follow-up activities to ensure an optimal conclusion for your organization. 

XYMOGEN Director of Regulatory Affairs Taneesha (Routier) Rogers, J.D. and NSF consultant Nicole Leitz will serve as joint presenters. Rogers, who currently chairs CRN’s Legal Committee, is the legal, regulatory and compliance leader for a supplement manufacturer and ensures facility and product compliance. Leitz has more than 20 years of experience within the good manufacturing practices (cGMP) industry for food, supplements, pharmaceuticals, OTCs and medical devices. 

This fee-based education event is available to both CRN members and non-members, with members paying $299 per module (total $598) and non-members being charged $349 each (total $748). Group rates are available for organizations who have three or more employees participating. 

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 180+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics.  Follow us on Twitter @CRN_Supplements and LinkedIn.