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The global COVID-19 pandemic forced the FDA to halt domestic and foreign inspections, leaving drug and device manufacturers waiting for pre-approval inspections, missing user-fee approval dates and stuck in official action indicated status. Unless your inspection was deemed “mission critical,” it didn’t happen.
But that’s starting to change. The FDA stated in July that it would resume certain domestic inspections and this presentation can help you prepare.
FDA inspections expert Kalah Auchincloss will share how assessments are proceeding and what criteria the organization is using to determine which sites are inspected. Through Auchincloss’ experienced perspective, you’ll gain insights into how to prepare for an on-site review, from extended records requests to appropriate personnel access. We’ll also consider how the FDA is deciding on remote inspections and ways to equip your team for this method of assessment.
Presentation Takeaways:
- FDA Criteria for In-Person Inspections
- Safety and the COVID-19 Advisory Rating system
- Alternatives to On-Site Inspections
- Records requests, including access to electronic databases, screen shots, live-video functions, or long-running documents
- Remote and hybrid assessments
- Appropriate personnel access
- Preparation for FDA Inspections
- Gaining clarity on domestic inspections criteria
- Standard approaches to 704(a) requests
- The Likelihood of Foreign Inspections Resuming
- Mutual Recognition Agreements (MRA)
- Pharmaceutical Inspection Co-Operation Schemes (PIC/S)
Whether your site is chosen for an on-site inspection, will go through a remote review or is awaiting assessment, you need to be prepared. Let us help ensure your team is ready for whatever interactions with the FDA come next.
Meet Your Presenter
Kalah Auchincloss, senior vice president and deputy general counsel at Greenleaf Health, Inc., spent six years at the FDA prior to joining Greenleaf in 2017. Her time at the agency included roles at the CDER’s Office of Compliance and as deputy chief of staff to the FDA commissioner. She has earned both her JD and MPH and has spent more than a decade working on food and drug legal, policy, and regulatory issues.
Who Will Benefit
- Pharmaceutical and biotech companies
- Medical device companies
- Regulatory affairs professionals
- Government affairs professionals
- Quality unit professionals
- Inspections and audit staff
- Post-market safety staff
- QSR and GMP professionals