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

Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…

Strategic Interviewing & Selection: Getting the Right Talen…


Conflict Resolution in a Remote Workplace

2-Hour Virtual Seminar on How to Conduct an Internal Harass…

Workplace Investigations 101: How to Conduct your Investiga…

Cleanroom, Microbiology and Sterility Assurance Practices f…

5 Key Components of Good Manufacturing Practices to obtain …

Successfully Negotiating the Labor Agreement

Understanding the incredible uses and fallbacks of ChatGPT

Wage And Hour Laws: Ensuring Compliance With The Fair Labor…

How to Manage Conflict in the Workplace

Neutralizing Harassment - How to Promote the Proactive Pers…

Human Error Reduction Techniques for Floor Supervisors

Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…

Using Better Managerial Decision Making - to get great resu…


Changing Behavior: Why Rewards and Punishments Often Aren't…

Excel - Pivot Tables - The Key To Modern Data Analysis and …


Using Stay Interviews To Improve Employee Retention & Engag…

Form W-9 Compliance to Avoid Penalties: TIN Verification, B…

Using High-Performance Coaching for Managers to Address Per…



FDA Technology Modernization Action Plan (TMAP) and Impact …

FDA Audit Best Practices - Do's and Don'ts

Stay Interviews: A Powerful and Low-Cost Employee Engagemen…

Become an excellent Critical Thinker to greatly improve you…

Learn the Do's and Don'ts of Opening Business Bank Accounts


Project Management for HR, Administrative Professionals, an…

Writing Effective 483 and Warning Letter Responses

Dealing With Difficult People In Life & Work