Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual inspections and obtaining documents in lieu of inspection. For companies seeking approval for new products or preparing for an inspection to resolve an FDA warning letter, it is important to know what inspection alternatives are possible.
Arnold & Porter and Lachman Consultant Services, Inc. will discuss virtual FDA inspections, including how medical products companies should engage with FDA, prepare for virtual inspections and respond to any compliance issues that may arise.
Speakers
- Mary D. Oates, PhD, Lachman Consultant Services, Inc.
- Ricki A Chase, MS, Lachman Consultant Services, Inc.
- Howard Sklamberg, Arnold & Porter, Life Sciences and Healthcare Regulatory
See here for registration information
