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Implementing a Robust and Compliant Change Control Program

November 12, 10:00 AM PDT | 1:00 PM EDT| Duration: 90 Min

Sponsored by ComplianceOnline

Click Here to register $249.00

Click Here to register and receive  recording $529.00

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur.

At the completion of this course, attendees will be able to:

  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records.
  • Understand all the required components of a thorough Change Control record.
  • Understand all the elements of effective Change Control management:
    • How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes.
    • Ensure changes do not negatively impact the business or established marketing authorization.
    • How to incorporate a Quality risk based approach to evaluating proposed changes
    • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics

Areas Covered in the Webinar:

  • Topic 1: Regulatory Guidance Review

    • FDA (CFR)
    • EU (EurdraLex)
    • ICH Q10

    Topic 2: Review all Elements of a Change Control Record

    • Discuss the importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes.
    • Ensure changes do not negatively impact the business or established marketing authorization.
    • How to incorporate a Quality risk-based approach to evaluating proposed changes
    • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
    • Understand what steps should be taken post implementation to confirm the objectives were achieved

Instructor Profile:

Kelly Thomas
Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.