Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to their facilities, products, and/or quality systems. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP-related changes occur. Documentation of change control, including document authoring, updates, archiving, and related activities is not only a critical component of this exercise but is also mandated by all global health authorities.
This course will discuss regulatory expectations from the FDA, EU, and ICH perspectives, review all the required components of a thorough change control program, and discuss the elements regarding the successful management of an effective change control system.
At the completion of this course, attendees will be able to:
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:
At the completion of this course, attendees will be able to:
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:
Kelly Thomas
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.
ChatGPT and Project Management: Leveraging AI for Project M…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Practice Safe Stress ™: Preventing Burnout While Building R…
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Writing Effective Job Descriptions
HR Metrics and Analytics 2026- Update on Strategic Planning…
High-Impact Performance Management: Tools, Tactics & Coachi…
Validation Statistics for Non-Statisticians
Batch Record Review and Product Release
Human Factors Usability Studies Following ISO 62366 and FDA…
Best Practices for FDA Computer System Audit Preparation in…
Fire Without Fear: How to Legally Terminate an Employee
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
The Importance of the first 5 seconds when presenting
Burnout to Fired-up : Recognizing and Preventing Burnout in…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Managing Toxic & Other Employees Who Have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Better Mind, Better Life: Unlocking Your Full Potential
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Human Error Trends as AI Enters GMP Operations: What QA Lea…