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Development and Audit of Complaint Handling and MDR Processes

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy


Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.

A firm must implement an effective system to capture, document, correct and trend complaints, and equally important, to evaluate and identify customer feedback as to whether it qualifies as an MDR event. This webinar will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action. Also addressed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. The application of risk management to a complaint handling system will be included.

Areas Covered in the Session:

  • FDA requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • What constitutes an MDR event
  • Evaluation of feedback as MDR: gray areas
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program

Who Will Benefit:This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Executive/senior management
  • Regulatory management
  • QA management
  • Any personnel who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.

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