Regulatory & Risk Management
The weeklong Regulatory & Risk Management stream offers a comprehensive view of the steps required of bioprocess organizations to support regulatory filings and maintain control over product quality and safety. Two case study forums present best practices for design space development, process characterization, and new strategies and tools for detection, prevention and handling of viral contamination incidents in biomanufacturing. And a 1.5 training seminar presents detailed information in a tutorial format on the requirements and informal expectations of the major regulatory agencies at preclinical, clinical and commercial stage.
Bioprocess Quality and Regulatory Compliance
Training Seminar: Current and Emerging Global Regulatory Expectations for Analytical
Viral Clearance and Safety of Biologics