Restricted Operations Due to Coronavirus Outbreak

For the safety of our community, UWPCE has restricted operations due to the coronavirus outbreak.

For more information, see our FAQ

Product Development & Manufacturing Systems

collapse

Course Details

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

Get Program Details

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
  Stay up to date with emails featuring career tips, event invitations and program updates.       Sign Up Now