PTI - international

Course Description

The Bad News - the CMC landscape continues to evolve, resulting in firms risking delayed product approval and other FDA enforcement actions.  

The Good News - The greatest risk comes from vague FDA requirements: they demand compliance, but don't define what that is.  When you become an authority on FDA's expectations of CMC for biotechnology and can correctly interpret the requirements, you will establish your value within your organization and be ready for the challenges ahead.  

Complying with Chemistry, Manufacturing and Controls (CMC) Requirements for Biopharmaceuticals begins with an examination of the current FDA CMC requirements and addresses CMC challenges unique to biopharmaceutical products including specification setting, product characterization, master/working cell bank issues, etc. You will learn exactly what to include in the IND and BLA and how to plan effectively for FDA/sponsor meetings.  When you return to your job, you will be well versed on how to comply with international registration requirements, demonstrate biologic product comparability, report post-approval process changes and much more.