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Recorded Webinar

Best Practices for A Medical Device Complaint Handling System

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

This webinar is intended to help you get familiar with the best practices for the medical device complaint handling system. This webinar is further intended to provide guidance on how to meet the regulatory requirements for handling any complaints concerning all medical device types.

Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products.

This webinar will discuss medical device complaint handling procedure requirements and how to achieve compliance and how to remain compliant. At the end of the webinar, you will get familiarized with the system for handling all types of medical device complaints.

The presentation will cover the following areas:

  • Overview and review of the applicable statutes and regulations
  • Definitions
  • What to do when complaints are received?
  • How to process complaints
  • What processes need to be in place?
  • When to investigate complaints
  • When to open a CAPA(s).
  • Contents of records of investigation
  • Enforcement actions: case studies
  • Lessons learned


Apply for this webinar

Who should attend

Anyone who is interested in learning more on FDA Medical Device Regulations

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