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
Join this webinar to learn more - https://247compliance.us/developing-and-managing-an-effective-change-control-program/2088?through=RuthMartine11thJulyLI&sm_grc
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