Process Validation for Medical Devices

Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.

This course has been designed to focus on process validation for medical devices. Day one will review the Regulatory and Quality Management System (QMS) links to process validation – essentially the need for validation. It will look at the preparation steps to be taken, including initial Risk Assessment, User Requirement Specifications (URS), the format of URS and include a practical review of bad versus good examples. 

Day two of the course reviews the Installation Qualification, Operation Qualification and Performance Qualification process (IQ, OQ and PQ ) reviewing how this fits with regulatory needs and technical documentation. It will also look at the validation master plan and discuss continuous PQ and when that may be appropriate. Additionally, validation protocol content and execution, covering the recording of findings, managing excursions from required performance, plus other considerations will be reviewed.

Data integrity with an overview of the GAMPv (Good Automated Manufacturing Process) for software will also be included. 

This is an excellent opportunity to receive a practical approach to Process Validation for Medical Devices.