FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference? – Webinar Recording/Transcript
Whether you know the difference between a “remote regulatory assessment” and a “remote interactive evaluation,” one thing is clear: You need to understand both as the FDA expands its use of remote oversight tools.
In this presentation, Grace McNally, a senior vice president of regulatory compliance at Greenleaf Health — and a 33-year veteran of the FDA — explains everything you need to know regarding the agency’s ongoing use of remote tools.
She clarifies 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.”
- 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 presentation led by a former FDA official.
Meet Your Presenter
Grace McNally is a senior vice president of regulatory compliance at Greenleaf Health. She joined Greenleaf after a 33-year career with the FDA. At Greenleaf, she helps pharmaceutical and medical technology companies strengthen corporate quality systems, develop compliance strategies, ensure inspection readiness, and develop and communicate corrective action plans.
During her early FDA career, she was a drug and device investigator in the Office of Regulatory Affairs before moving to the Office of Compliance in the Center for Drug Evaluation and Research (CDER), where she served as a compliance officer and senior policy advisor. In 2015, she became branch chief of CDER’s Office of Process and Facilities in the Office of Pharmaceutical Quality (OPQ). She later took a position in OPQ’s policy office as the division director for regulations, guidance and standards, where she oversaw the development of quality guidance for drugs requiring premarket approval as well as over-the-counter monograph drug products.
Who Will Benefit
- NDA, ANDA and BLA applicants
- Quality professionals
- Regulatory affairs professionals
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March 7, 2023