World of Compliance Module

Learning Objectives

Upon completion of the abridged Manufacturing and Product Quality unit, you will be able to:

• Describe requirements for manufacturing and product quality
• Explain the case management and guidance process
• Describe the manufacturing assessment and pre-approval process
• Explain the biologics regulation
• Explain international compliance
• Describe how manufacturers are to handle recalls, shortages and certificates
• List the steps of the inspection process
• Describe the systems approach to manufacturing drug products

Now that you understand the objectives we are trying to achieve, let's begin this unit.