Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance

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.

• Interpret FDA, EU and ICH requirements for compliant change control records
• Explain the required components of a thorough change control record
• Recognize the critical aspects of documentation and document control
• Apply the elements of effective change control management

• 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

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.

This course will be of benefit to anyone working in manufacturing, facilities, or quality environment on a global or domestic scale who is involved in change control or quality systems. This includes personnel in:

• Production
• IT
• Facilities and Engineering
• Validation
• Quality Control
• Quality Assurance
• Regulatory Affairs

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.