Introduction – (approx. 1 paragraph) Clearly introduce the focus area/topic (eg new MDR; QbD, PAT Technologies ) of the journal and some general detail on the topic in the contextof validation in Pharma, biopharma or medical device as appropriate.b. Summary of the article – (3-4 paragraphs) capture a summary of the key points in the journal along with providing some specific examples from the article. You may capture how the text is organised, include the main aim, the approach to research and the key findings. Note this is NOT a direct extract from the abstract/conclusion of the journal – you need towrite it in your own words to demonstrate your own understanding.c. Critique – (5-7 paragraphs) Present a balanced discussion and evaluation of the strengths,weaknesses and notable features of the article. Remember it is important that you critique it based on specific criteria (see supporting document EDU_Critical Review_Tips). Include at least a paragraph on positive aspects and another on the negative or limitations of the study. You should capture where you think the article can be improved in terms of ideas, research approach, theories or frameworks used. This section MUST be supported by other secondary research…approx. min target amount of 6 supporting articles.d. Contribution – (2-3 paragraphs) Describe the contribution the paper provides to our knowledge, in other words what do we know as a result of the paper that we did not know beforehand i.e.e. Conclusion – (1-2 paragraphs) Compare the findings presented in this paper with your own experience in your work environment – relevancy, ease of adoption, not relevant to your organisation & why. Consider its relevancy and determine whether it would be worth conducting further research in this area due to its applicability for your work.f. References – list all supporting documents which you had to research relative to your evaluation. not your own specific knowledge but that in the field of validation i.e. why is this research important to validation in general.

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