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.
Managing Toxic Employees: Strategies For Leaders To Effecti…
Hiring and Retaining Employees in this Crazy Economy
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel Power Skills: Master Functions, Formulas, and Macros …
Project Management for administrative professionals
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Copilot and HR: An Introduction for HR Professionals
California Meal and Rest Breaks: What You Don't Know Can Co…
Bootcamp for New Managers and Supervisors: Develop These Es…
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Emotional Intelligence: Mastering the Emotions of Great Lea…
How To Conduct An Internal Harassment And Bullying Investig…
Managing Difficult Employee Conversations
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
The Importance of the first 5 seconds when presenting
Female to Female Hostility @Workplace: All you Need to Know
How to Write Effective Audit Observations: The Principles f…
FDA Proposes Framework to Advance Credibility of AI Models