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 …
Empowering Conflict Resolution: Letting Go to Gain Control
Developing an Agile Workforce with Emotional Intelligence (…
FDA Regulation of Artificial Intelligence/ Machine Learning
Compliance Under Fire: Navigating I9 Immigration Raids & …
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Human Error Reduction Techniques for Floor Supervisors
How To Conduct An Internal Harassment And Bullying Investig…
Secrets Of Psychology - Why People Do The Things They Do
FDA Compliance And Laboratory Computer System Validation
Leadership: Strategic Planning and Decision Making
Polish your Presence on Linkedin - The Powerful Profile
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Factors Usability Studies Following ISO 62366 and FDA…
Leveraging Artificial Intelligence in HR
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Understand the Different Contexts in DAX, The Filter Contex…
Understanding and Analyzing Financial Statements
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
The Importance of Storytelling in Project Management
Defensive Documentation: Protecting Your Organization from …
Topic Name/Course Title Leading a Project and Team in Stres…
Power Bi - Turn Bad Data Into Great Data In Minutes
OSHA Reporting: What are OSHA's Reporting Requirements?
Onboarding is NOT Orientation - How to Improve the New Empl…
Copilot and HR: An Introduction for HR Professionals
Establishing Appropriate Quality Metrics and Key Performanc…
How to Write Effective Audit Observations: The Principles f…
Basic Accounting and Finance for Human Resources Profession…
EBIT/EBITDA - Understanding Your Profit and Loss Statement-…
FDA Audit Best Practices - Do's and Don'ts
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Controller Challenges in Changing Times: New Roles as Strat…
The Importance of the first 5 seconds when presenting
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Sunshine Act Reporting - Clarification for Clinical Research
How to Prepare For and Host a FDA Inspection and Respond to…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Managing Toxic Employees: Strategies For Leaders To Effecti…