When 2020 began, none of us anticipated extended work from home orders, mask requirements, and hand sanitizer shortages. The COVID-19 pandemic has required industries to become more flexible—and pharma is no exception.
FDA and other global regulatory agencies moved toward a model of “virtual inspections,” consisting primarily of sharing documents and even site photos/videos over the internet in addition to teleconferencing. Even as the pandemic wanes, virtual inspections are likely to remain an option for regulators, particularly, for inspecting sites overseas due to time constraints, budget shortfalls, travel restrictions, etc.
How are virtual inspections conducted? What technologies are available? And how are they different from in-person inspections?
Register to immediately download, “The FDA Inspection Landscape in Mid-2020 and a Look at Virtual Inspections,” a report from Redica Systems Senior GMP Quality Expert Jerry Chapman.
Based on a summary of talks by former FDA personnel Howard Sklamberg and Ricki Chase at the June Arnold & Porter webinar, “FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections,” this report offers a definitive guide to handling virtual inspections.
What You Will Learn
- How to determine your risk of inspection
- Strategies for preparing for a virtual inspection
- New technologies for facilitating a virtual inspection
Who Should Download
Anyone involved in inspection planning at pharmaceutical and medical device manufacturing facilities.
About the Expert
Jerry Chapman is Redica Systems’s Senior GMP Quality Expert. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality roles. In corporate quality, he designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the US and internationally.
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