Delivering in-house training in CFR820, Medical Devices- Quality Systems Regulation Call Rachel McLean +44(0)1292 671555

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CFR 820 Quality System Regulation (QSR)

One Day Awareness Workshop Contents
This workshop requires some understanding of Quality Management Systems and is designed for personnel who wish to gain further knowledge of the principal requirements of CFR 820 regulation. The key topics covered are:
 

  • Regulatory Overview

  • General Provisions

  • Quality System

  • Quality System Requirements

  • Design Controls

    • Device History File

  • Purchasing Controls

  • Identification & Traceability

  • Receiving, In Process and Finished Device Acceptance

  • Acceptance Status

  • Statistical Techniques

  • Production & Process Control

  • Inspection Measuring & Test Equipment

  • Process Validation

  • Labelling & Packaging Control

  • Handling Storage Distribution & Installation

  • Nonconforming Product

  • Corrective & Preventive Action

  • Complaint Files

  • Servicing

  • Document Controls

  • Records

    • Device Master record

    • Device History Record

    • Quality System Record

 

 

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

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