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World of Compliance Module
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Manufacturing and Product Quality
comprehensive
Learning Objectives
Introduction
Case Management and Guidance
Manufacturing Assessment and Pre-approval
Biologics Regulation
International Compliance
Recalls, Shortages and Certificates
Conducting an Inspection
The Systems Approach
Knowledge Check
FAQ
Certificate of Completion
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Knowledge Check
Which of the following are regulatory actions that the FDA may use in the case of objectionable conditions noted during the inspection of a manufacturing facility?
Warning letter
Untitled letter
Injunction for closure
All of the above
Which of the following is not a task of the Office of Compliance?
Developing current good manufacturing practices (cGMPs)
Issuing preferred manufacturing guidelines (PMGs) to manufacturers of non-prescription drugs
Providing technical input on cGMPs
Coordinating program activities between CDER and the FDA Office of Regulatory Affairs (ORA)
Which of the following are tasks of the Office of Compliance within the framework of the pre-approval program?
Conducting pre-inspection briefing for applications that have been marked for extra background information
Providing technical assistance for pre-approval inspections
Reviewing domestic pre-approval inspection reports
All of the above
Which of the following is not a category of products to be submitted as biologics license applications?
Therapeutic DNA plasmid products
Therapeutic synthetic peptide products of more than 40 amino acids
Monoclonal antibody products for in vivo use
Therapeutic recombinant DNA-derived products
A recall is the removal of a product from the market, is not mandated by any regulatory body in the U.S., and is a voluntary action recommended by the government. True or false?
True
False
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