Quality by Design and Process Analytical Technology for Biopharmaceuticals
Two day short course for individuals that are involved in product and process development, regulatory, quality assurance and control and manufacturing of biotech therapeutics. Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.
This course aims to clarify the key concepts that interplay in defining and implementing QbD and PAT towards development and manufacturing of biotech products. This will be achieved via a sequence of lectures and group work. Concepts discussed include: Critical Quality Attributes (CQA), Design Space, Risk Assessment, Process Characterization, Process Analytical Technology, Scale-up, and Technology Transfer. At the end of the course, the audience will be able to explain what these concepts mean, the role they play in QbD/PAT implementation and the interplays amongst them.
Instructors: Anurag Rathore (IIT, India), Seongkyu Yoon (UMass Lowell)
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