Changes and updates to regulatory compliance is inevitable, including how the FDA is managing inspections for medical device manufacturers. Join us to understand the inspection oversight in the New Age, how FDA’s inspection priorities changed to meet the challenges of a COVID-19 environment and what we can expect going forward.
- The factors that determine mission critical inspections
- Examples of FDA suggested alternative inspection tools
- What did the passage of FDORA authorize for medical device inspections
- How did the restructuring of ORA aim to meet current challenges
- FDA’s rising concerns and current thinking on foreign facility inspections
- Resiliency Roadmap for FDA's inspectional oversight
- How FDA QSR & ISO 13485 Harmonization impacts Med Device Companies
Who Will Benefit:
Meet Your Presenters
Life Sciences Expert and Consultant
Meritz & Muenz LLP
Judith Meritz has more than 30 years experience representing Pharma and Medical Device companies. She specializes in strategic planning and compliance mediation concerning the FDA and other international regulatory agencies. She has held key regulatory and legal positions for companies including Medtronic, Covidien, Henry Schein and the American Red Cross. She chaired the medical device practice at two Washington DC law firms.. She has been the key player in interactions with the FDA and drafted inspection responses to numerous FDA 483’s and Warning Letters. She has led companies to achieve successful outcomes and avoid further enforcement actions. She taught at the FDA CDRH college on inspection readiness and adverse event corrective actions.