Conventional good manufacturing process inspections were upended by the pandemic. And the FDA and other agencies are forging ahead to build new inspection models.
Starting in Sept. 2021 the FDA intends to return to a more normal schedule of inspections based on three pandemic scenarios — most likely, best case and worst case.
The FDA’s ability to monitor drug facility compliance in FY 2020 was significantly impacted by COVID-19 — with only 745 inspections completed for the year vs. 1,367 in FY 2019. The FDA also had to rely on mutual recognition agreements with other global regulators to perform 183 of those 2020 inspections, the Office of Pharmaceutical Quality (OPQ) said in its 2020 annual report, which covers the period Oct. 1, 2019 to Sept. 30, 2020.
In FY 2020, regulatory audits were conducted at 2,842 medical device manufacturing facilities and an additional 536 were conducted in FY 2021 as of March 2021. Throughout the public health emergency, the FDA has leveraged Medical Device Single Audit Program (MDSAP) audit reports which have provided valuable information on the quality management systems for domestic and foreign device firms.
What will regulators look for going forward into 2022? Are virtual inspections here to stay? Will they return to in-person or become a combination of virtual and in-person?
At the 16th Annual FDA Inspections vSummit, you’ll gain insights and tips to help plan for upcoming virtual or in-person inspections. With the expertise of FDA officials and seasoned professionals, this virtual summit will tackle complex inspection issues head-on — providing details that will ease the stress of determining your next steps.
Choose from three different tracks — Drugs & Biologics, Medical Devices and Clinical Trials — to guarantee your inspectional readiness and comfort with the tools and tactics you’ll need to apply on the job.
There’s no other summit where you’ll leave as well prepared for the complicated task of preparing for an inspection. Don’t miss out on this chance to learn from inspections experts and prepare your team for compliance and success.
Donald D. Ashley, J.D.
Director, Office of Compliance
Elizabeth Miller, Pharm.D.
Assistant Commissioner Medical Products & Tobacco Operation, Office of Regulatory Affairs
David Borasky, MPH, CIP
Vice President, IRB Compliance
Principal, Director of Inspection Readiness
Lead Quality Systems and Compliance Consultant
King & Spalding LLP
Principal, Regulatory Compliance
Greenleaf Health, Inc.
Who Will Benefit:
- Executive Management
- Regulatory Affairs
- Quality Assurance/Quality Control
- Legal and Compliance Officers
- Consultants/Service Providers