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…
Workplace Investigations 101: How to Conduct your Investiga…
Project Management for administrative professionals
The Monte Carlo Simulations in Excel for Risky Investments
Onboarding is NOT Orientation - How to Improve the New Empl…
Dealing With Difficult People: At Work & In Life
Transform Data into Insights: A Beginners Guide to Excel Pi…
Construction Lending And Real Credit Administration: Evalua…
Understanding Accounting for non - Accounting professionals
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
Treating Employees Like Adults: Discipline versus Empowerme…
7 Ways To Beat Burnout: Without Quitting Your Job
How to Write Procedures to Avoid Human Errors
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Proposes Framework to Advance Credibility of AI Models
Ethical Terminations: Navigating Employee Exits with Legal …
Understanding EBITDA – Definition, Formula & Calculation
Project Management for Non-Project Managers - Scheduling yo…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Payments Fraud Detect & Prevent Check, ACH and P-Card Schem…
Managing Toxic & Other Employees Who have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Excel - Pivot Tables - The Key To Modern Data Analysis and …