PRI Training's MedAccred Process Validation: Part 1 training course provides the basics of Process Validation as initiated by the Global Harmonization Task Force document on Process Validation. This document is considered to be the cornerstone for medical devices’ process validation strategy and focuses on the general applicability to manufacturing (including service and installation) processes for medical devices.

Course Topics Include:

• Definitions: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Verification versus Validation
• Statistical Methods and Tools

MedAccred Process Validation audit criteria have been developed and are being included in all MedAccred Task Group audit criteria to ensure suppliers have the capability and objective evidence to handle process validation. It is therefore essential that all MedAccred stakeholders be knowledgeable in this methodology. 

Who should attend? 

• MedAccred Auditors
• Staff Engineers
• Task Group Members