Corrective and Preventive Actions (CAPA)
Contents |
Abstract
A brief summary of the key points of your article
The context of CAPA
Project management
Regulatory authorities
The 7 steps of CAPA
Step 1: Identification
Step 2: Evaluation
Step 3: Investigation
Step 4: Analysis
Step 5: Action plan
Step 6: Implementation
Step 7: Follow-up
CAPA Report and documentation
Limitations
Critically reflect on the tool/concept/theory and its application context. What can it do, what can it not do? Under what circumstances should it be used, and when not? How does it compare to the “status quo” of the standards – is it part of it, or does it extent them? Discuss your article in the context of key readings / resources provided in class. Substantiate your claims with literature
Annotated Bibliography
Provide key references (3-10), where a reader can find additional information on the subject. The article MUST make appropriate references to the and reference material provided in class – either incorporating it as a source, or critically discussing aspects that are missing from it but covered by this article. Summarize and outline the relevance of each reference to the topic (around 100 words per reference). The bibliography is not counted in the suggested 3000 word target length of the article.
