Developing And Managing An Effective Change Control Program

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, its 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 perspectives, review all the required components of a thorough Change Control program; as well as, and discuss the elements regarding the successful management of an effective Change Control system.

WHY SHOULD YOU ATTEND?

Course Objectives: 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

LEARNING OBJECTIVES

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

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

https://247compliance.us/developing-and-managing-an-effective-change-control-program/2088?through=RuthMartine11thJulyLI&sm_eventsget