This webinar equips the attendee with information required to design, manage, and sustain a change control system that meets and exceeds FDA requirements. Change control accomplishes three things for an organization:
- Protect the organization agaist product liability
- Production against Regulatory exposure
- Excessive Waste
Why Should You Attend: Attendees will learn the following:
- Regulatory requirements for a change control system.
- Business requirements for a change control system:
- The different phases of a change:
- The three types of changes:5.Change life cycle:
- Connections between CAPA and change control:
- Connections between process validation and change control
Areas Covered in the Session: The webinar will cover the following:
- Define what a change is
- Define the purpose of a change control sysytem
- Define regulatory requirements for a change control system
- Define the work flow
- Define business requirements for a change control system
- Explore tools for risk assessment
