Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Learn what FDA, EU and ICH expect from change control, the components of a complete change control record, and how to manage documentation and the change process.
Speaker
Kelly Thomas
cGMP quality and validation consultant · 20+ years in cGMP industry
Overview
Regulators expect pharmaceutical and medical device companies to manage every change to facilities, products and quality systems in a systematic way. This 90-minute change control training explains how to build a change control program that is compliant and effective.
Change is inevitable, so a robust program is needed to make sure unnecessary or cGMP-impacting changes don't slip through. Documentation, including authoring, updates and archiving, is a critical part of the process and is required by health authorities worldwide.
The course reviews regulatory expectations from the FDA, EU and ICH perspectives, the required components of a thorough change control program, and what it takes to manage the system successfully.
Why attend: Weak change control lets uncontrolled changes reach products, facilities and quality systems, and regulators worldwide require documented, systematic change management. This course shows how to meet FDA, EU and ICH expectations and keep change records complete. It suits anyone involved in change control or quality systems in manufacturing, facilities or quality roles, including production, IT, facilities and engineering, validation, QC, QA and regulatory affairs.
What’s covered
- Why companies need a systematic approach to change
- FDA, EU and ICH expectations for change control
- Required components of a thorough change control program and record
- Documentation and document control: authoring, updates and archiving
- Managing an effective change control system
Who should attend
What you get
About the speaker
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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