Effective Systems for Change Control in the Pharmaceutical Industry

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Why Should You Attend:

Change control is a complex but very important aspect of GMP compliance. Many companies struggle with inefficient and overly complicated systems that are paper and time-intensive due to a lack of solid understanding of the purpose of change control and the methods that can be employed to make it more efficient. This webinar explains the purpose of change control and what works best to implement it in a GMP governed setting.

Learning Objectives

• Understand the purpose of change control
• Learn where the requirement is listed in the GMP regulations
• Learn how to make the change control process more efficient
• Understand the importance of compliance with regulatory submission requirements related to change and the role of Regulatory Affairs in the change control process

Areas Covered in the Webinar:

• Purpose of change control
• GMP requirement for change control
• Change control in commercial versus investigational product manufacturing
• Points to consider for change control SOPs
• Levels of change and what is not a “change”
• Considerations for regulatory submissions related to changes
• Annual report
• Changes Being Effected
• Changes Being Effected/30 days
• Prior Approval changes

Who Will Benefit:

This course is designed from a pharmaceutical manufacturing perspective; however, since the main focus is on techniques and practices, the course material may be equally applied to biologics and medical device environments. It will benefit:

• Change proposal authors
• Reviewers/approvers of change controls
• Change control system owners
• Production staff/management
• Engineering staff/management
• Validation staff/management
• QA and QC staff/management
• Regulatory affairs staff/management