World of Compliance Module

Learning Objectives

Upon completion of the comprehensive Risk Management Surveillance Tools unit, you will be able to:

• Recognize risk management and surveillance tools used in the drug manufacturing industry
• Describe Drug Registration and Listing (DRLS)
• Explain the Adverse Drug Experience (ADE ) Reporting Program
• Describe the Drug Quality Reporting System (DQRS)
• State the purpose of the Field Alert Reporting System (FARS)
• Describe risk evaluation and mitigation strategies (REMS) for drug manufacturers
• Describe the Drug Product Surveillance Sampling Program
• List the procedures for the Drug Product Surveillance Sampling Program
• Describe the post-market Drug Surveillance Program

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