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 …
ChatGPT and Project Management: Leveraging AI for Project M…
Workplace Investigations 101: How to Conduct your Investiga…
Project Management for administrative professionals
The Monte Carlo Simulations in Excel for Risky Investments
Onboarding is NOT Orientation - How to Improve the New Empl…
Dealing With Difficult People: At Work & In Life
Transform Data into Insights: A Beginners Guide to Excel Pi…
Construction Lending And Real Credit Administration: Evalua…
Understanding Accounting for non - Accounting professionals
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
Treating Employees Like Adults: Discipline versus Empowerme…
7 Ways To Beat Burnout: Without Quitting Your Job
How to Write Procedures to Avoid Human Errors
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Proposes Framework to Advance Credibility of AI Models
Ethical Terminations: Navigating Employee Exits with Legal …
Understanding EBITDA – Definition, Formula & Calculation
Project Management for Non-Project Managers - Scheduling yo…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
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…
Payments Fraud Detect & Prevent Check, ACH and P-Card Schem…
Managing Toxic & Other Employees Who have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Excel - Pivot Tables - The Key To Modern Data Analysis and …