This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.
WHY SHOULD YOU ATTEND?
Change Control is a critical element of the Quality Management System. Changes to processes, equipment, facilities, materials/components, suppliers, test methods, specifications, etc; must be properly managed to prevent unintended consequences, and to comply with regulatory requirements. Improper change control can result in significant compliance and product quality problems.
During this course, the speaker will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. After completion of this course, you will be able to implement immediate steps in executing a change control form.
AREA COVERED
- Overview of Change Control Regulatory Requirements
- What is Change Control? / Why Change Control?
- Types of Changes Subject to Change Control
- Like for Like
- Specification changes
- Facility Changes
- Equipment Changes
- Emergency Changes
- Change Control Proposal
- Proper documentation
- Elements to be included
- Change Assessment (Risk, Impact) and Approval to Execute
- Impact to products
- Impact to facility
- Impact to Regulatory Filings
- Change Control Board Development
- Areas of Responsibilities for Board Members
- Establishing Action Items
- Establishing Deadlines
- Final Implementation of Change
- How to close out a change
- Effectiveness of the change
- Change Control Documentation
- Hard copy systems
- Electronic systems
LEARNING OBJECTIVES
- Identify what constitutes a change
- Learn how to properly categorize a change
- Demonstrate how to write/execute a Change control proposal, assessment and close out
- Discuss the establishment of a change control board
WHO WILL BENEFIT?
- Pharmaceutical professionals involved in the manufacture of products
- All levels of management
- Quality professionals
- Compliance Officials
- Quality Assurance Personnel
- Regulatory Affairs
- R&D and Engineering Staff
- Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
- Supply Chain Managers
Change Control is a critical element of the Quality Management System. Changes to processes, equipment, facilities, materials/components, suppliers, test methods, specifications, etc; must be properly managed to prevent unintended consequences, and to comply with regulatory requirements. Improper change control can result in significant compliance and product quality problems.
During this course, the speaker will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. After completion of this course, you will be able to implement immediate steps in executing a change control form.
- Overview of Change Control Regulatory Requirements
- What is Change Control? / Why Change Control?
- Types of Changes Subject to Change Control
- Like for Like
- Specification changes
- Facility Changes
- Equipment Changes
- Emergency Changes
- Change Control Proposal
- Proper documentation
- Elements to be included
- Change Assessment (Risk, Impact) and Approval to Execute
- Impact to products
- Impact to facility
- Impact to Regulatory Filings
- Change Control Board Development
- Areas of Responsibilities for Board Members
- Establishing Action Items
- Establishing Deadlines
- Final Implementation of Change
- How to close out a change
- Effectiveness of the change
- Change Control Documentation
- Hard copy systems
- Electronic systems
- Identify what constitutes a change
- Learn how to properly categorize a change
- Demonstrate how to write/execute a Change control proposal, assessment and close out
- Discuss the establishment of a change control board
- Pharmaceutical professionals involved in the manufacture of products
- All levels of management
- Quality professionals
- Compliance Officials
- Quality Assurance Personnel
- Regulatory Affairs
- R&D and Engineering Staff
- Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
- Supply Chain Managers
Speaker Profile

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
Upcoming Webinars

Transform Data into Insights: A Beginners Guide to Excel Pi…

Leadership: Strategic Planning and Decision Making

Onboarding Best Practices for 2025: Proven Strategies to Po…

Seeking Truth: Detecting Truth, Lies and Deception in a Wor…

Managing Difficult Employee Conversations

Copilot and HR: An Introduction for HR Professionals

How to Document Employee Discussions and Why it is Important

Dealing With Difficult People In Life & Work

How to Write Effective Audit Observations: The Principles f…

OSHA Requirements for Supervisors, Project Leaders & HR - W…

FDA Compliance And Laboratory Computer System Validation

4-Hour Virtual Seminar on Transformational Leadership - The…

3-Hour Virtual Boot Camp on Easier Excel Automation with VB…


2025 Handbook Overhaul: Navigating Critical Updates! Federa…

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…

Negotiating Skills For Professional Results - Winning Strat…

Building Thriving Teams: Proactive Strategies for Managers …

Designing Employee Experiences to Build a Culture of Compli…

Empowering Conflict Resolution: Letting Go to Gain Control

Navigating Alcohol and Drug Addiction Protections Under the…

President Trumps Executive Orders And What They Mean to Emp…

The Anti-Kickback Statute: 2025 - Year in Review

FDA Technology Modernization Action Plan (TMAP) and Impact …

Form W-9 Compliance: TIN Verification, B Notices, and Avoid…

Workplace Investigations 101: How to Conduct your Investiga…

50+ new Excel features so far this decade


FDA Regulation of Artificial Intelligence/ Machine Learning

From Challenges to Compliance: Understanding Dietary Supple…

Utilizing HR Metrics to Illustrate & Improve Human Resource…

Do's and Don'ts of Documenting Employee Behaviour, Performa…


The Importance of the first 5 seconds when presenting

Why EBITDA Doesn't Spell Cash Flow and What Does

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…


Impact Assessments For Supplier Change Notices

The Monte Carlo Simulations in Excel for Risky Investments

Understanding the incredible uses and fallbacks of ChatGPT

California Meal and Rest Breaks: What You Don't Know Can Co…

Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…


Onboarding is NOT Orientation - How to Improve the New Empl…


Gossip-Free: Leadership Techniques to Quell Office Chatter

Female to Female Hostility @Workplace: All you Need to Know


6-Hour Virtual Seminar on Learning the Highlights of Excel …