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 …
Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…
The five qualities every successful leader must develop
Better Business Writing-How to Write Right
Employee Handbooks: 2025 Critical Issues
Effectively Handle Toxic People for Better Productivity and…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
ChatGPT and Project Management: Leveraging AI for Project M…
Data Privacy and Protection - Data protection laws and best…
How to Lead and Manage a Narcissistic Employee
Use of AI and GPT for Finance Professionals
Analytical Method Validation Under Good Laboratory Practic…
How to Write Contracts for Procurement Professionals
Excel What-If-Analysis Decision-Making Tools
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Dealing With Difficult People: At Work & In Life
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
Retention Starts Here: Stop Losing Your Critical Talent and…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
AI and Human Resources: The Great Opportunity!
Cyber Security Incident Response Team Training Program
Excel Power Skills: Master Functions, Formulas, and Macros …
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
6-Hour Virtual Boot Camp on Microsoft Power BI
Finance & Accounting 101 Simplified
6-Hour Virtual Seminar on Learning the Highlights of Excel …