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.
Expert Solution Preview
Introduction:
The assignment requires the students to select an FDA Warning Letter from the provided list and conduct a full root cause analysis. The students are then required to develop a corrective and preventive action plan (CAPA) based on the analysis. This assignment will help the students understand the importance of root cause analysis and the process of developing a CAPA.
Answer:
The students should select an FDA Warning Letter from the provided list and conduct a full root cause analysis using the CAPA template provided. The analysis should identify the root cause of the issue mentioned in the warning letter. The root cause analysis should be comprehensive and should consider all the possible causes of the issue.
Based on the root cause analysis, the students should develop a corrective and preventive action plan. The plan should address the identified root cause and propose actions to prevent the issue from reoccurring. The plan should be feasible, effective, and should consider the resources available.
Overall, this assignment will help the students apply their knowledge of root cause analysis and develop a CAPA. The assignment will also help the students understand the importance of addressing the root cause of an issue and developing an effective plan to prevent it from reoccurring.
