For this assignment, you will select an FDA Warning Letter from the list provided and complete a full root cause analysis. Based on this analysis, you will develop a corrective and preventive action plan (CAPA). When citing any resources, be sure to
Steps
1. Select an FDA Warning letter from
this list
Download this list
.
2. Using this
CAPA template
Download CAPA template
, conduct and document a full root cause analysis.
3. Based on this analysis, develop a corrective and preventive action plan in the same document.
CAPA Template
Student Name:
Warning Letter Number:
Date of Issue:
Complete 1 table for each observation identified in the warning letter
Observation #:
Description of
Observation
Root Cause
(include
methodology for
conducting root
cause (e.g. 5Whys, Fishbone,
etc):
Corrective Action
plan (include
actual
corrections and
the type of
evidence that
would be
provided to
demonstrate
completion)
Preventative
Action Plan
(include type of
evidence
required to
demonstrate
completion
/effectiveness)
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Formatting
Title Page
Citation
Outline
