Implementing a Robust and Compliant Change Control Program

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