FALLS CHURCH, Va. (PRWEB) February 27, 2023
Grace McNally, senior vice president of regulatory compliance at Greenleaf Health, and a 33-year veteran of the FDA, will clarify how the FDA is using remote oversight for inspections of facilities and explain manufacturers’ rights and responsibilities. She will also explain the difference between a remote regulatory assessment and a remote interactive evaluation.
- Understand the FDA’s approach to regulatory oversight during a public health emergency, including its use of remote assessment tools
- Understand the differences between mandatory and voluntary assessments
- Learn about FDA priorities, key guidance, and other policy documents that describe remote regulatory assessments, including the agency’s Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID Emergency guidance
- Learn about the Center for Drug Evaluation and Research compliance activity based on remote regulatory assessments, including how the success of remote alternative tools and approaches may be useful even after the pandemic
FDA’s Remote Assessments vs. Remote Interactive Evaluations:
Do You Really Know the Difference?
A WCG FDAnews Webinar
Tuesday, March 7, 2023, 1:30 p.m.-3:00 p.m. EST
Easy Ways to Order:
By phone: 888.838.5578 or 703.538.7600
About WCG FDAnews:
WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.