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Recorded Webinar

Current Good Manufacturing Practice for Medical Devices

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 current Good Manufacturing Practice (cGMP) for medical devices in the US. This webinar is further intended to provide guidance on the cGMP requirements set out in the Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.

Understanding quality system regulations and requirement can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.

This webinar will discuss Quality System (QS) regulations, requirements and compliance. At the end of the webinar, you will get familiarized with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic devices.

The presentation will cover the following areas:

  • Overview and review of the US QSRs for medical devices.
  • Flexibility of the QSRs.
  • Definitions.
  • Quality system requirements.
  • Management responsibility.
  • Audits.
  • Personnel.
  • Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes.
  • Design history file (DHF).
  • Device master record (DMR)
  • Quality system procedures
  • Purchasing controls
  • Inspection, measuring and test equipment
  • Process validation
  • Corrective and preventive action (CAPA)
  • Complaint files
  • Servicing
  • Quality requirements for premarket approval (PMA) application
  • 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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