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.
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
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
Understanding the incredible uses and fallbacks of ChatGPT
Project Management for administrative professionals
Accounting For Non Accountants : Debit, Credits And Financi…
Coaching At Work- Improving Employee Engagement And Perform…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Onboarding is Not Orientation: How to Improve Your New Hire…
Using High-Performance Coaching for Managers to Address Per…
21 CFR Part 11 - Compliance for Electronic Records and Sign…
California Meal and Rest Breaks: What You Dont Know Can Cos…
Writing Techniques for Auditors and Risk Management Profess…
Responding to EEOC Discrimination Charges-What's Your Busin…
Implementing an Effective Human Error Reduction Program
Conflict Resolution - Prevent, De-escalate, Resolve
When Employees Travel: Wage and Expense Rules Employers Mus…
Female to Female Hostility @Workplace: All you Need to Know
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Validation Statistics for Non-Statisticians
Form 1099-MISC and 1099-NEC Compliance Update 2024
Project Management for Non-Project Managers - Scheduling yo…
GAMP5, Second Edition and Alignment with Computer Software …
The Totally Organized Professional Is All About Outcomes
Why EBITDA Doesn't Spell Cash Flow and What Does
Understanding the Math of HR… So You Can Show How HR Impact…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
Re-imagine Finance & Accounting Made Simple. Three Webinars…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
How To Conduct An Internal Harassment And Bullying Investig…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…