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…
DOL Reverses Course on Independent Contractor Rule for 2026…
The emergence of Social Determinants of Healthcare
Leadership: Strategic Planning and Decision Making
Beginners Guide to Data Transformations in Power Query
Understanding EBITDA – Definition, Formula & Calculation
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
ChatGPT and Project Management: Leveraging AI for Project M…
Managing Projects When AI Joins the Team: Human Judgment, A…
Negotiating Skills For Professional Results - Winning Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Paying and Receiving Payments for Referrals: You Can Go to …
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Tattoos, hijabs, piercings, and pink hair: The challenges …
The Importance of the first 5 seconds when presenting
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
The New W4 - How to Assist Employees with Proper Completion…
Transforming Anger And Conflict Into Collaborative Problem …
Microsoft Excel PivotTables: Basics of Data Analysis for Bu…
4-Hour Virtual Seminar on Management Skills For New Managers
Fatal Errors Employers Make When Updating Employee Handbook…
Tools for New Managers: Connecting with Employees to Optimi…
Supervisor Excellence: Skills to Lead High-Performing Teams
The Manager’s Playbook for Leading After Layoffs: Quickly R…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Mastering Performance Management: Strategies for Continuous…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Pivot tables beginner to advanced + 20 advanced Pivot table…
AI Fundamentals for All Leaders and Managers: How to Work S…
Rewiring Your Emotional Triggers: Leading with Clarity and …
The $1M Mistake: EEOC Discrimination Claims Employers Make …
Using Claude in Excel for Productivity, Automation & Data A…
AI in B2B Marketing: What Your Compliance Team Needs to Know