World of Compliance Module

Learning Objectives

Upon completion of the comprehensive 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.