Implementing A Change Control Quality System Successfully

Danielle DeLucy

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This 90-minute accredited online training course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.

Course Objective

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.

Course Outline

  • Overview of Change Control Regulatory Requirements
              What is Change Control? / Why Change Control?
              Types of Changes Subject to Change Control
              Like for Like
              Specification changes
              Facility Changes
              Equipment Changes
              Emergency Changes

  • Change Control Proposal
  • Proper documentation
  • Elements to be included
  • Change Assessment (Risk, Impact) and Approval to Execute
          Impact to products
          Impact to facility
          Impact to Regulatory Filings
          Change Control Board Development
          Areas of Responsibilities for Board Members
          Establishing Action Items
          Establishing Deadlines
          Final Implementation of Change
          How to close out a change
          Effectiveness of the change
          Change Control Documentation
          Hard copy systems
          Electronic systems

Target Audience

  • Pharmaceutical professionals involved in the manufacture of products
  • All levels of management
  • Quality professionals
  • Compliance Officials
  • Quality Assurance Personnel

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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