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READY-TO-STREAM COURSE

IQ, OQ & PQ in 2026

What Now Counts as Sufficient Validation Evidence

Examine how qualification and process validation evidence is evaluated today, and how testing rationale, acceptance criteria, and execution records support GMP decisions.

COURSE OVERVIEW & STRUCTURE

Validation evidence quality receives increasing scrutiny.

Qualification teams routinely decide how much evidence is necessary to support equipment, systems, and process performance without creating unnecessary testing activity. Organizations often struggle to connect testing scope, acceptance criteria, deviations, and supporting rationale into evidence that clearly supports qualification conclusions.

The session reviews current expectations for qualification and process validation evidence across IQ, OQ, PQ, and PPQ activities. Practical scenarios are used to examine testing rationale, acceptance criteria, deviation handling, documentation practices, and the quality of evidence used to support qualification and validation conclusions.

WHAT YOU’LL LEARN

Judging qualification evidence sufficiency

  • Modern expectations for IQ, OQ, PQ, and PPQ evidence
  • Determining when qualification evidence is sufficient
  • Developing meaningful acceptance criteria and test justification
  • Balancing scientific rationale with practical execution
  • Evaluating reduced testing and verification approaches
  • Managing deviations and discrepancies during qualification
  • Identifying low-value documentation activities
  • Building sustainable evidence-based qualification programs

WHO SHOULD ATTEND

Designed for professionals responsible for generating, reviewing, approving, or relying on qualification and validation evidence.

Quality Assurance

Validation

Engineering

Manufacturing

Technical Operations

Quality Control

Process Development

Technology Transfer

Regulatory Affairs

Compliance

Operations

Quality Systems

FACULTY

Meredith Crabtree

Meredith Crabtree brings more than 30 years of experience across pharmaceutical, medical device, biologics, laboratory, cosmetic, supplement, and animal health operations. Having supported manufacturing, packaging, labelling, regulatory assessments, inspections, recalls, and quality systems activities, she offers practical perspective on evaluating qualification evidence, validation rationale, documentation quality, and GMP decision-making.

AFTER YOU REGISTER

Everything related to your course lives in one place.

FDB1419

After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

  • You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
  • Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
  • At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
  • After the session, the playback becomes available on the same course page so you can revisit important sections.
  • Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

 

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

IQ, OQ & PQ in 2026

What Now Counts as Sufficient Validation Evidence

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