Description :The guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, required reporting to the FDA. For those changes that require reporting, a better understanding of a more effective post-approval submission strategy by the regulated by the industry.Areas Covered in the Session :BackgroundDefinition of Established ConditionsElements of a Control Strategy that May be Considered Established ConditionsSections of CTD that Typically Contain Established ConditionsEstablishing Conditions as Part of the Application Submission and ReviewChanges to Established ConditionsConclusionWho Will Benefit:A must attend webinar for professionals/organizations in Pharmaceutical, Biologics, Contract Laboratories, API Manufacturers and Medical Device industries. The teams that would benefit include:Senior ManagementRegulatory Affairs TeamsCompliance OfficerQuality Assurance TeamsProcess Engineering TeamsChange Management ProfessionalsValidation Specialists