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.
Effective And Defensible Documentation Of Employee Problems…
Stress, Change And Team Resilience Through Humor: An Intera…
2026 EEOC & Employers: Investigating Claims of Harassment …
Burnout to Fired-up : Recognizing and Preventing Burnout in…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Be a Better Leader: Dealing with your Inner Control Freak, …
Project Management For Administrative Professionals
HR Metrics and Analytics 2026- Update on Strategic Planning…
The Emotionally Intelligent Manager: Thriving Under Pressure
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
ChatGPT and Project Management: Leveraging AI for Project M…
GROUPBY and PIVOTBY functions. Pivot table killers?
Stop Letting That Difficult Person Ruin Your Day: Effective…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Recruiting Top Talent in a Digital Era
Copilot and HR: An Introduction for HR Professionals
The Importance of the first 5 seconds when presenting
How to Write Procedures to Avoid Human Errors
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
AI for Excel Professionals: Enhancing Productivity with Cha…
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
ChatGPT for HR - Build HR Policy Framework and Strategy
Boost Financial Analysis with Claude in Excel
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…