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.
LEARNING OBJECTIVES
At the completion of this course, attendees will be able to:
- Interpret the requirements of the FDA, EU, and ICH guidelines regarding compliant Change control records.
- Explain all the required components of a thorough Change control record
- Recognize the critical aspects of documentation and document control
- Apply all the elements of effective Change control management
WHO WILL BENEFIT?
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:
- Production
- IT
- Facilities and Engineering
- Validation
- Quality Control
- Quality Assurance
- Regulatory Affairs
At the completion of this course, attendees will be able to:
- Interpret the requirements of the FDA, EU, and ICH guidelines regarding compliant Change control records.
- Explain all the required components of a thorough Change control record
- Recognize the critical aspects of documentation and document control
- Apply all the elements of effective Change control management
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:
- Production
- IT
- Facilities and Engineering
- Validation
- Quality Control
- Quality Assurance
- Regulatory Affairs
Speaker Profile

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.
Upcoming Webinars

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…