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Implementing a Robust and Compliant Change Control Program 2021

This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.

Why Should You Attend:

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

Who Will Benefit:

  • Operations
  • Quality Assurance
  • Regulatory Affairs
  • Validation

Contact Organizer

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(1+) 206-575-7771
World Medical Events Company
12922 SE 299th Street, Auburn WA 98092 USA