Process Validation for Biopharmaceutical Manufacturing

Reviews the regulatory requirements and methods for validating Pharma/biopharmaceutical manufacturing processes, including the general approach to validation; a review of important biotechnology manufacturing processes, and the strategies and requirements for their validation. Specific topics include validation of buffer/media preparation systems, upstream/downstream processes, master plan development and execution, cleaning validation, analytical methods requirements, protocol writing and execution, and handling of deviations; as well as The history of Process Validation; Risk-based Analysis; Quality by Design (QbD); Process Analytical Technology (PAT); Design of Experiments (DOE); Process Optimization and Characterization. (1.6 CEUs)

Course no. 58785 $65.00
Days: Wednesday & Thursday
Wed, 09/22/2010 - 8:00am - Thu, 09/23/2010 - 5:00pm
Presenter(s):
Center Sponsor: Capstone Center

Raleigh, NC