Whether you know the difference between a “remote regulatory assessment” and a “remote interactive evaluation,” one thing is clear: You’ll need to understand both as the FDA expands its use of remote oversight tools.

In this webinar, Grace McNally, a senior vice president of regulatory compliance at Greenleaf Health — and a 33-year veteran of the FDA — will explain everything you need to know regarding the agency’s ongoing use of remote tools.

She’ll clarify how the FDA is using remote oversight for inspections of facilities just like yours and explain your rights and responsibilities.

Along the way you’ll get your burning questions answered, including: What weight do these remote tools carry? How will the FDA use the information it gathers? Is participation in this manner voluntary or mandatory? What are the consequences of refusing to participate?

And, of course, you’ll learn the difference between a “remote regulatory assessment” and a “remote interactive evaluation.”

Webinar Takeaways:

• The FDA’s approach to regulatory oversight during the public health emergency, including its use of remote assessment tools
• The important differences between mandatory and voluntary assessments
• FDA priorities and key guidances 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
• Center for Drug Evaluation and Research compliance activity based on remote regulatory assessments, including how the success of remote alternative tools has shown that such tools and approaches may be useful even after the pandemic

Remote oversight tools are here to stay. Get ready — and stay compliant — with this webinar led by a former FDA official.