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.
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
How to Write Effective Audit Observations: The Principles f…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …