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.
Interactive dashboards & analytics in Excel
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Medical Device Hazard analysis following ISO 14971
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FDA Audit Best Practices - Do's and Don'ts
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Unauthorized Transactions – Reg E vs Nacha Operating Rules
Secrets Of Psychology - Why People Do The Things They Do
New Form I-9: Documents and Policies that Ensure ICE I-9 Co…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Claude AI For CPAs & Finance Professionals: Best Practices …
Managing Complex Projects - Project Management
Project Management For Administrative Professionals
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Onboarding is NOT Orientation - How to Improve the New Empl…
Negotiating Skills For Professional Results - Winning Strat…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
NEW Nacha Rule - Third-Party Sender (TPS) Roles and Respons…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Paying and Receiving Payments for Referrals: You Can Go to …
Validation Statistics for Non-Statisticians
Construction Lending And Real Credit Administration: Evalua…
Human Factors Usability Studies Following ISO 62366 and FDA…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Excel Power Skills: Master Functions, Formulas, and Macros …