The Leader in Quality Life Science Training
READY-TO-STREAM COURSE
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
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”.
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© All rights reserved