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 are 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 are 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 are 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.
Stop Letting that Difficult Person Ruin your Day - Effectiv…
FDA's Technology Modernization Action Plan (TMAP) And Impac…
Nailing the Candidate Experience, Attracting Talent
Developing and Implementing Inclusive Leadership Strategies
Supervising a Human Error Free Environment: You can do a Lo…
Improving Organizational Performance through Enhanced Emplo…
Creative Leadership through Emotional (EQ) and Humor (HQ) I…
FDA's new Cosmetic labeling requirements
New Announcement! DHS Terminates The I-9 Form Remote Option…
Why EBITDA Doesn't Spell Cash Flow and What Does
Faster Payments in Today's World - Details on the Different…
Payroll Management - Tips To Make Payroll Processing Easier…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Introduction to Design of Experiments
Small Business Management Made Simple: Tools, Tips & Techni…
Design Control for Medical Devices and Combination Products
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Employee Business Expense Reimbursement (2023 Updates)
Project Management for administrative professionals
Accounting For Non Accountants : Debit, Credits And Financi…
Establishing Appropriate Quality Metrics and Key Performanc…
Managing Toxic & Other Employees Who have Attitude Issues
Onboarding is NOT Orientation - How to Improve the New Empl…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
The Importance Of Documentation For Supervisors And Managers