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.
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.
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.
Danielle DeLucy
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 …
Controller Challenges in Changing Times: New Roles as Strat…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
How to Prepare For and Host a FDA Inspection and Respond to…
Sunshine Act Reporting - Clarification for Clinical Research
The Importance of the first 5 seconds when presenting
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Complaint Handling and Management: From Receipt to Trending
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Understanding Artificial Intelligence (AI) and the Incredib…
6-Hour Virtual Boot Camp on Microsoft Power BI
Onboarding is NOT Orientation - How to Improve the New Empl…
The Monte Carlo Simulations in Excel for Risky Investments
ChatGPT and Project Management: Leveraging AI for Project M…
Project Management for administrative professionals
Workplace Investigations 101: How to Conduct your Investiga…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Understanding Accounting for non - Accounting professionals
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
7 Ways To Beat Burnout: Without Quitting Your Job
Treating Employees Like Adults: Discipline versus Empowerme…
Understanding EBITDA – Definition, Formula & Calculation
Ethical Terminations: Navigating Employee Exits with Legal …
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
How to Write Procedures to Avoid Human Errors
FDA Proposes Framework to Advance Credibility of AI Models
Project Management for Non-Project Managers - Scheduling yo…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…