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Jul 2017
Jul 2017


Aloft Orlando Downtown 500 South Orange Avenue Orlando , Florida 32801
Tel: (407) 380-3500
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Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's


Course Description
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years' experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.

During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, filing for both Medical Device Reports (MDR) and eMDR, effective and appropriate communication with the appropriate regulatory agencies in the event of a recall and how UDI's factor into reporting. She will discuss, all the new FDA Guidance's that have issued in 2016 discussing FDA's thoughts on firms processes for MDR Reporting, a correction and removal action to avoid a recall crisis, including required recordkeeping, expectation from an FDA perspective on achieving regulatory compliance. In addition, she will provide key factors in implementing and maintaining compliance with the regulations from real life experiences of FDA.

Medical Device Reporting (MDR) and the implementation of the Final Rule on eMDR and recall compliance are critical to the continued survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. Ineffective or lack of proper Complaint Handling is cited as one of the top violations in a 483 issued at time of inspection by FDA. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR and Final Rule on eMDRs & recall compliance and the interrelationship of Complaint Handling, CAPA and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

Learning Objectives:

  • Understand how to comply with complicated Compliant Handling, MDR, eMDR and Recall requirements
  • Firms eMDR/ MDR reporting and FDA's handling of reports and UDI requirements for recalls
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Navigating the maze of New Draft and Final FDA’s Guidance’s with Post-compliance issues

Who will Benefit

  • Quality Assurance and Quality Control personnel responsible complaint handling and recalls
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Project Managers responsible for maintenance of Complaint Handling, troubleshooting, and understanding QSR
  • Risk Managers
  • CAPA Teams
  • Complaint handling units
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Regulatory/legislative affairs professionals
  • IT department supporting complaint handling
  • Regulatory affairs reporting units.

For Registration

Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)




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