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.
Leadership: Strategic Planning and Decision Making
The Top Ten Excel Functions Everyone Should Know
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Empowering Conflict Resolution: Letting Go to Gain Control
Retention Starts Here: Stop Losing Your Critical Talent and…
Gossip-Free: Leadership Techniques to Quell Office Chatter
California Meal and Rest Breaks: What You Don't Know Can Co…
Managing Difficult Employee Conversations
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Workplace Investigations 101: How to Conduct your Investiga…
Copilot and HR: An Introduction for HR Professionals
Excel Power Skills: Master Functions, Formulas, and Macros …
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Bootcamp for New Managers and Supervisors: Develop These Es…
Stress, Change And Team Resilience Through Humor: An Intera…
Is Your Workforce Change Ready? A Leader’s Guide to Quickly…