Do you understand the process, forms and expectations following an FDA Inspection? What are the possible outcomes - EIR, 483, Untitled Letter, NAI, VAI, OAI and NIDPOE? How can you best prepare and respond?
We will review the documents exchanged during an inspection and the process followed by FDA to determine whether a warning letter will be issued. We will identify and define the possible outcomes of an inspection. Successful responses to the Agency are dependent upon effective application of root cause analysis (RCA) and Corrective and Preventive Action (CAPA) techniques. These concepts will be demonstrated through the interactive warning letter group activity using polling and Q&A technologies.
Participants will receive a simple CAPA Planning Form and a sample regulatory response letter which may be used to support your response to FDA Inspectional Observations.
Describe at least 3 regulatory actions FDA can take following a Clinical Investigator (CI) inspection.
Discuss appropriate strategies for responding to inspection findings.
Evaluate the effectiveness of proposed Corrective and Preventive Actions