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 …
Discover how Emotional Intelligence turns AI from a technic…
AI in B2B Marketing: What Your Compliance Team Needs to Know
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Effective And Defensible Documentation Of Employee Problems…
Stress, Change And Team Resilience Through Humor: An Intera…
2026 EEOC & Employers: Investigating Claims of Harassment …
Be a Better Leader: Dealing with your Inner Control Freak, …
Burnout to Fired-up : Recognizing and Preventing Burnout in…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Project Management For Administrative Professionals
HR Metrics and Analytics 2026- Update on Strategic Planning…
The Emotionally Intelligent Manager: Thriving Under Pressure
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
Launch Your Career: The Ultimate Guide for Emerging Profess…
GROUPBY and PIVOTBY functions. Pivot table killers?
ChatGPT and Project Management: Leveraging AI for Project M…
Stop Letting That Difficult Person Ruin Your Day: Effective…
Recruiting Top Talent in a Digital Era
Copilot and HR: An Introduction for HR Professionals
The Importance of the first 5 seconds when presenting
How to Write Procedures to Avoid Human Errors
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
AI for Excel Professionals: Enhancing Productivity with Cha…
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
ChatGPT for HR - Build HR Policy Framework and Strategy
Boost Financial Analysis with Claude in Excel
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…