Implementing a Change Control Quality System Successfully

Duration: 90 Minutes
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 Quality System
Instructor: Danielle DeLucy
Product ID: 508754
Objectives of the Presentation
  • Identify what constitutes a change
  • Learn how to properly categorize a change
  • Demonstrate how to write/execute a Change control proposal, assessment and close out
  • Discuss the establishment of a change control board
Why Should you Attend
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.

Areas Covered
  • 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
Who will Benefit
  • Pharmaceutical professionals involved in the manufacture of products
  • All levels of management
  • Quality professionals
  • Compliance Officials
  • Quality Assurance Personnel
  • Regulatory Affairs
  • R&D and Engineering Staff
  • Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
  • Supply Chain Managers
Topic Background
FDA, EMA, and other international regulatory agencies require that there be an adequate change control system as a subsystem of a company's overall quality system. FDA has issued a number of recent 483 citations and Warning Letters for inadequate change control. FDA expects proposed changes to be thoroughly reviewed by appropriate subject matter experts, in order to assure that the changes do not result in negative outcomes. Changes must also be properly justified, assessed for risk, implemented, and documented. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval. Ultimately, improper change control can lead to negative 483 findings, Warning Letters, sub-standard product, or product recall.

An effective change control system relies upon the combination of sound procedures and personnel who understand how to properly describe, assess, and implement changes. Just completing a change control form is not enough. All involved personnel must have subject matter expertise, critical thinking skills, and the ability to clearly document their actions within the change control system, or related systems. At the end of the day, it should be clearly understood what changed, why the change was made, what risks were identified and/or mitigated, how the change was implemented, and whether the change was effective.
$375
Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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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