This webinar will provide an overview of the International Council for Harmonization (ICH) Q12 guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed.

This webinar will appeal to all technical, quality operations and regulatory personnel in drug or combination product development and commercialization.