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Medical Devices; Current and Future Challenges
October 12, 2022 @ 11:00 am - 12:00 pm
FDA Operations Update: Topics following the execution of the 2020 Resiliency Roadmap for FDA Inspectional Oversight plan.
Remote Regulatory Assessments: Insight into how to manage electronic-based FDA inspections and assessments of medical device quality systems, with the continued use of RRA.
1 CE Contact Hour
Location: ZOOM Webinar
Speaker: Janet Pulver, FDA Medical Device Senior Operations Officer
Moderators: Allison Oliva, OCRA Professional Liaison
Synopsis: Medical Devices; Current and Future Challenges
This presentation will provide an update on FDA operations following the execution of the 2020 Resiliency Roadmap for FDA Inspectional Oversight plan intended to ensure continued protection of public health during the COVID-19 pandemic and will discuss how the agency is handling current and future challenges as we move to a post-COVID era. The presentation will also provide insights into how to manage electronic-based FDA inspections and assessments of medical device quality systems, with the continued use of Remote Regulatory Assessments and an increased number of Investigators collecting and managing records electronically onsite during inspections.
Janet Pulver is the FDA’s Division 3 Medical Device Senior Operations Officer and serves as national expert in the Medical Device and Radiological Health program areas. Mrs. Pulver joined the FDA in 2008 and has since conducted more than 200 medical device inspections (domestic and international), including inspections covering Human Tissue and Radiological Health regulations. She is also an Instructor and content advisor for the FDA’s national Medical Device course. She came to the FDA with more than 10 years of experience in FDA-regulated industry, working in quality and regulatory positions in clinical research, tissue banking and medical devices. Prior to that, she spent eight years as a Chemistry Medical Technologist working with IVDs. Mrs. Pulver holds Certifications from ASQ (Certified Manager of Quality and Organizational Excellence, Certified Quality Auditor and Certified Six Sigma Green Belt), RAPS (Regulatory Affairs Certification), and AATB (Certified Tissue Bank Specialist). Mrs. Pulver earned a Bachelor of Science from the University of Puerto Rico and a Master of Science in Administration from Central Michigan University.
Allison Oliva, RAC, OCRA Professional Liaison
Comprehensive Clinical Consulting
OCRA Members and Non-OCRA Members: FREE
Certificates of attendance will be emailed after the event.
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