Performance Qualification (PQ)

Purpose

Performance Qualification or PQ is the 3 rd of the 3 validation steps. Performance qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification test requirements defined in the User Requirements Specification (or possibly the Functional Requirements Specification). Performance qualification is performed by experienced users when the system is released.

 Target Audience

Employees of High Tech, Food and Pharmaceutical companies whose work directly or indirectly involves the operation and validation of operational equipment and/or systems.

 Intent

This training consists of 2 half days (2*4 hours) and deals with the functionality of the PQ process, the PQ protocol and the method of control. During this training we will set up a PQ protocol by using the requirements set up earlier and we will simulate an implementation.

 Program

·        Functionality of a PQ

·        When to create a PQ

·        Making use of the established requirements

·        Draft, review and authorization process PQ Protocol

·        Setting up test cases

·        Job description operator, validation executor and witness

·        Perform Qualification

·        Dealing with deviations

 Qty participants   8 - 12