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Product Development & Manufacturing Systems


Course Details

This course can only be taken as part of the Certificate in Biomedical Regulatory Affairs.

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About this Course

This course offers a survey of product development and manufacturing concerns, including quality control; scale-up; GMPs and quality systems; the FDA inspection process; and FDA regulatory actions. We’ll also focus on the Quality System Inspection Technique (QSIT).

What You'll Learn

  • Design and manufacturing product requirements
  • Drugs/biologics manufacturing systems requirements, including validation
  • Device quality system requirements and establishing quality systems
  • Device process validation
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