The 17th Annual FDA Inspection Summit will provide the insights you must know so you can prepare for, and sail through, your inspections into 2023 and beyond.
In-person inspections may be back but the FDA’s remote “alternative tools” are also here to stay. Hear about the agency’s use of each and its inspection plans moving forward at the summit.
Industry experts, including past and present FDA officials, are the ones presenting and leading “hands-on” sessions. You’ll get valuable, up-to-the-minute intelligence to guide you through current and future inspection-related complexities.
The FDA’s Elizabeth Miller, Pharm.D., assistant commissioner for medical products and tobacco operations in the Office of Regulatory Affairs kicks off the summit by sharing the agency’s latest plans and initiatives so you can be better prepared for both on-site and virtual/remote inspections.
From there, it’s data collection and tools … what you must and must not do at the inspection … validating your systems and equipment for compliance … and much more. You’ll come away with practical advice you can use for reliably better inspections.
Choose from three breakout tracks curated to deliver the information you need for inspection success: Drugs & Biologics, Medical Devices and Clinical Trials. You’ll get the answers to your burning questions on:
- The transition from the FDA’s Quality Systems Regulation (QSR) to the proposed Quality Management System Regulation (QMSR) — the difference between ISO 13485 and the current 21 CFR Part 820 and what the FDA is doing to prepare for harmonization
- The takeaways from the Remote Regulatory Assessment draft guidance — what records or other information the FDA may request, what they can use it for, the submission timeframe, how to submit them and more
- The impact of artificial intelligence, machine learning and other technologies on inspections, including the FDA’s plans to modernize its inspection-related technology systems
- What the FDA’s emphasis on data integrity means for you — and what quality culture has to do with it
- New trends in 483 observations and warning letters
These industry experts and FDA officials have a great deal to share with you. Attend the summit in person or livestream it from your home or office, so that you can prepare for, and sail through, your next inspection.