VITALIS GMP Webinar Series Part 2: Qualification and Validation of Equipment

Presented by:

Part 2 of the GMP Webinar Series will examine the qualification and validation of equipment designated for GMP environments. The discussion will focus on the documentation associated with the qualification and validation process, with emphasis on the following;

• User Requirement Specification (URS)

Outlines the equipment specifications required by the customer

• Installation Qualification and Operation Qualification (IQ/OQ)

Validates that the equipment has been installed as per manufacturers specifications and that the equipment operates as designed

• Performance Qualification (PQ)

Validates that the equipment performs as required, consistently, under real-world conditions

• Turnover Package

Documented evidence of materials of construction and calibration of measuring devices

Participants should leave the webinar with a better understanding of what is required from a manufacturer when purchasing a GMP-compliant piece of equipment.

Event host, Kiran Dayaram, GMP Specialist