Establishing a Compliant and Effective Change Control Program

Establishing a Compliant and Effective Change Control Program
Product Code: : FDAQ-9268
Speaker : Kelly Thomas
Date : 31st May 2019
Time : 10:00 AM PST | 01:00 PM EST
Duration : 90Min

Topic Background:

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. This Change Control training course 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 of an effective Change Control system.

Overview:

This Change Control training course 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.

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.

Why Should You Attend:

After the completion of this course, the participants will have the knowledge, understanding, and tools to develop, implement and manage a highly effective and GMP compliant Change Control Program.

Objectives of the Presentation:

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

             - Understand what steps should be taken post-implementation to confirm the objectives were achieved

Areas Covered in the Session:

Regulatory Guidance Review

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

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

How to Present Quality Metrics to Manage Timely Closure of Change Control records

  • Discuss appropriate metrics for change control programs
  • Discuss Key Performance Indicators for change control programs
  • Review a Quality Dashboard example to show how to display metrics/trends

Who will Benefit:

Operations employees that participate in Manufacturing, Engineering, Validation, Quality Assurance, and Regulatory Affairs as part of their job function - includes employees in the following departments:

  • Production
  • Engineering & Validation
  • Facilities / Maintenance
  • Quality Assurance
  • Regulatory Affairs

Speaker Profile:

Ms. Kelly 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.


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Available Options

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Recorded Session : ($229)

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