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.
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Strategic Interviewing & Selection: Getting the Right Talen…
Conflict Resolution in a Remote Workplace
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Workplace Investigations 101: How to Conduct your Investiga…
Cleanroom, Microbiology and Sterility Assurance Practices f…
5 Key Components of Good Manufacturing Practices to obtain …
Successfully Negotiating the Labor Agreement
Understanding the incredible uses and fallbacks of ChatGPT
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
How to Manage Conflict in the Workplace
Neutralizing Harassment - How to Promote the Proactive Pers…
Human Error Reduction Techniques for Floor Supervisors
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
Using Better Managerial Decision Making - to get great resu…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Using Stay Interviews To Improve Employee Retention & Engag…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Using High-Performance Coaching for Managers to Address Per…
FDA Technology Modernization Action Plan (TMAP) and Impact …
FDA Audit Best Practices - Do's and Don'ts
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Become an excellent Critical Thinker to greatly improve you…
Learn the Do's and Don'ts of Opening Business Bank Accounts
Project Management for HR, Administrative Professionals, an…
Writing Effective 483 and Warning Letter Responses
Dealing With Difficult People In Life & Work