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Best Practices for MDRs, Recalls, Corrections, and Removals Description: In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish (define, document and implement) adequate procedures for MDRs, recalls, corrections and removals. This webinar is intended to help device industry establish adequate procedures for MDRs, recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements. At the end of the webinar, you will leave actionably motivated in a way that you would plan, develop and execute the relevant procedures in a holistic manner. Objectives of the Presentation: o Applicable statutes and FDA regulations o Regulatory requirements for MDRs, recalls, corrections and removals o

Definitions

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How to report medical device adverse events

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Reporting requirements for the user facilities, manufacturers, and importers

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Recalls, corrections and removals (devices)

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Voluntary recalls and mandatory device recalls

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How to perform and document corrections and removals

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Checklist

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Enforcements: case studies

Who can Benefit: o CEOs o

VPs

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Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)

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Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs)

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Quality Professionals (Associates, Specialists, Managers, Directors or VPs)

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R&D (Engineers, Scientists, Managers, Directors or VPs)

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Complaint and risk management personnel

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Consultants


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Contractors/Subcontractors

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Other Interested Parties

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Tuesday, January 22, 2013 10:00 AM PST | 01:00 PM EST Live Session for one participant

Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)

Price:$486.00 Corporate Live Session 5 to 10 participants in single location. (For muliple location contact customer care)

Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.

Price: $288.00


Best Practices for MDRs