Product Development and Manufacturing Systems

Product development and manufacturing concerns (such as quality control, scale-up, GMPs and quality systems), the FDA inspection process and FDA regulatory actions are surveyed. Focus on the QSIT (Quality System Inspection Technique). Topics include:

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

Find the Offering That's Right for You

We offer programs throughout the year in different locations and learning formats designed to meet your education needs. To learn more about this program, select one of the following sections.