Jun 15, 2022
cGMP Facility Inspections Conducted by FDA: How Inspection Ready are You?
This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that are the primary focus during U.S. Food and Drug Administration (FDA) facility inspections.
FDA inspects facilities to ensure their compliance with regulations and laws surrounding the manufacturing, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the U.S. Attend this webinar to gain insight on how FDA approaches GMP facility inspections, with the goal of understanding how to always be inspection ready as an organization, and how best to prepare for inspection by FDA. This knowledge will assist businesses in better allocating and directing their compliance resources.
Prior to the COVID-19 pandemic, an inspector could drop by your facility at any time without advance warning. In light of the pandemic, FDA will now pre-announce domestic onsite inspections of regulated businesses, excluding tobacco inspections. Having a plan in place that includes inspection best practices will go a long way in eliminating the stress that undoubtedly comes when you’re put on notice that an inspection is imminent.
Join us on June 15, 2022 (10am-12pm PT / 1-3pm ET), when our expert presenters will:
Provide an overview of the current cGMP enforcement landscape – who, what, where and why FDA can inspect
Provide examples of how to prepare for an FDA inspection
Review the dos and don’ts of working with an FDA inspector in your facility
Share first account FDA inspection experiences
Asa Waldstein, CEO, Supplement Advisory Group
Will Woodlee, Esq.,, Partner, Kleinfeld, Kaplan & Becker, LLP / AHPA General Counsel
Steven Yeager, Director of Quality and Regulatory Affairs, Mountain Rose Herbs
AHPA Members: $199