Process Validation: How to Make Sense of the IQ/OQ/PQ Alphabet Soup

When:

Thursday, June 16 | 10:00 am - 10:45 am

Where:

Room 45

Level:

All Levels

Participant Type:

Product Development, Sourcing/Purchasing, Manufacturing, Operations, Quality/Regulatory


Process Validation: How to Make Sense of the IQ/OQ/PQ Alphabet Soup

Process Validation often trips up orthopedic companies despite its constant presence in the device manufacturing processes. This session begins with a reminder of the process validation basics, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). We’ll discuss a verifiable vs. special process and how process validation is connected to FDA regulations and guidance. Attendees looking for real-world examples will find them when the presentation walks through easy and hard scenarios of process validation. No matter your role, this session spells out essential steps in developing process validation plans and protocols.

Learning Objectives

  • Understand process validation basics, including IQ, OQ and PQ

  • Learn how process validation fits into FDA regulations and guidance

  • Receive advice on how to handle hard process validation scenarios


Speaker

Dale Tempco

Founder,

Dale Tempco Consulting