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MDR Program conforming to New FDA Guidance
Product ID: 705149
- Duration: 60 Min
FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.
Why Should You Attend:
This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. It includes reporting requirements, record keeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using the form 3500A.
Areas Covered in the Webinar:
- Reporting requirements
- Record keeping requirements
- Report timing
- Clarification of what “becoming aware” means
- Clarification of reporting using form 3500A
Who Will Benefit:
- Development Engineers
- Production Management
- QA/QC Personnel
- Regulatory Personnel
Edwin Waldbusser
Regulatory Consultant, Med Device Advisors
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.
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