IQ, OQ & PQ in 2026: What Now Counts as Sufficient Validation Evidence
Understand what constitutes sufficient and defensible IQ, OQ, PQ, and PPQ validation evidence in modern GMP environments — with real-world examples.
Instructor
Meredith Crabtree
GMP Quality Consultant & Validation Specialist

What You'll Learn
About the event
About this event
Validation expectations surrounding IQ, OQ, PQ, and PPQ activities continue to evolve as regulated companies balance scientific rigor, operational efficiency, lifecycle management, digitalized systems, and increasing regulatory scrutiny.
While most organizations maintain established qualification and validation procedures, many teams still struggle with a critical question: what now constitutes sufficient and defensible validation evidence within modern globally regulated GMP environments?
Regulators increasingly evaluate whether validation activities demonstrate meaningful scientific rationale, appropriate risk-based decision-making, traceable execution, and reliable evidence supporting intended system or process performance.
This practical 90-minute webinar examines modern expectations for IQ, OQ, PQ, and PPQ evidence within today's GMP systems. The session will explore how organizations can distinguish between low-value validation activity and evidence that genuinely demonstrates operational control, process understanding, and defensible qualification practices.
Real-world scenarios and practical examples will be used throughout the session to help participants strengthen validation reasoning, improve evidence quality, and build more sustainable validation strategies.
Code: FDB1419
Curriculum
Requirements
- Experience in pharmaceutical, biotech, or medical device validation
- Familiarity with IQ, OQ, PQ, or PPQ activities
- Working in or supporting GMP-regulated manufacturing or quality operations
Who Should Attend
Validation and Qualification Teams, Quality Assurance (QA) Departments, Quality Control (QC) Departments, Engineering Departments, Technical Operations, Manufacturing Departments, Regulatory Affairs Departments, Process Development and Technology Transfer, and Compliance and Quality Systems Professionals.
Areas Covered
Meet Your Instructor

Meredith Crabtree
GMP Quality Consultant & Validation Specialist
Meredith Crabtree has over 30 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting and specializes in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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