2016 - Webinar on Established Condition - The New FDA Guidance

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 :
Background
Definition of Established Conditions
Elements of a Control Strategy that May be Considered Established Conditions
Sections of CTD that Typically Contain Established Conditions
Establishing Conditions as Part of the Application Submission and Review
Changes to Established Conditions
Conclusion
Who 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 Management
Regulatory Affairs Teams
Compliance Officer
Quality Assurance Teams
Process Engineering Teams
Change Management Professionals
Validation Specialists