GlobalCompliancePanel to organize RAPS pre-approved webinar on "Managing Your Medical Device Reporting (MDR)Program for Compliance Success"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinaron the topic, "Managing Your Medical Device Reporting (MDR) Program for Compliance Success",on March 13.
- San Jose, CA (1888PressRelease) March 13, 2013 - Description:
This session informs attendees the ways by which adverse reporting has to be carried out in a medical device's company's Medical Device Reporting (MDR) Program to ensurecompliance success.
Since 1984; manufacturers, importers or user facilities of medical devices are required to report any adverse event for a product to the FDA. This is one of the necessary steps for regulatory compliance. This is done to ensure that adverse events are detected early and corrected promptly. A consumer or healthcare professional can use the MedWatch program to report any significant adverse event or problem with a medical product or device.
Although these regulations have been in force since 1984; there have been significant deviations to this rule. There has been underreporting of adverse events. In view of this, the FDA passed a new act, the Medical Device Reporting (MDR) Program on July 31, 1996 to ensure better reporting procedures. This webinar session will highlight the areas in which medical device manufacturers, importers or user facilities need to work to report adverse events to make sure that they are compliant.
This webinar will cover the following areas:
- What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- How will I know if I require more information about my medical device report?
- Reporting device-related deaths and serious injuries and when these are not treated as a product complaint
- Understand the manufacturer's reporting requirements and expectations
- Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
- Learn what constitutes an MDR and how to facilitate this for compliance success
- Develop, maintain, and implement written MDR procedures and achieve compliance
- Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary.
When:March 13, 10:00 AM PDT | 01:00 PM EDT
By whom:
David R. Dills, Independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in-vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems.
David currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
For whom:
The webinar will benefit
- All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview
- Regulatory Affairs
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors
- Engineering/Technical Services/Operations
- Consultants
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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