FDA GMP QSR: Servicing Requirements

If a medical device requires servicing, then procedures to define and control the servicing need to be approved. Service reports need to be recorded and reviewed to identify quality trends, opportunities for improvement and potential risks to patients or clinicians. The reports need to record the service details including the names of individuals performing the service, service dates, tests performed and outcomes. There are two key objectives associated with the “servicing” process. The first objective is to ensure that the devices are applied correctly in use and secondly to provide feedback to the manufacturer on device field performance.

QSR’s: Statistical Techniques >>>

Cause and Effect Diagram >>>
Just In Time Lean Manufacturing >>>
Process Validation Guidance. Protocol elements IQ OQ PQ >>>
Bottleneck Analysis >>>
Statistical Process Control ppt >>>

Medical Device Validation – Regulation. Requirements & current best Practices.

- - How to plan and implement a Validation program.
  - How to identify Validation requirements versus actual status.
  - The Life Cycle approach to Validation.
  - How to identify Validation Gaps and confirm Validation effectivity.
  - Reporting on the outcomes of Validations performed.
  - Use to develop your personal understanding.
  - Use as a support if providing training.
  - Details >>>