The purpose of this task is to perform an effective analysis of some of the current research in the area of Validation highlight some challenges facing individuals working in the area of validation today and to discuss whether the findings are applicable or not in your organisation1.
The Task Specifics:
1) Select one journal article from the list captured in the tile ‘Module Assessment’ under the heading
Assignment 1 – Journal Articles on the Validation Principles Moodle page.
2) Conduct a Review and analysis of the journal article under the following headings:
a. Introduction – (approx. 1 paragraph) Clearly introduce the focus area/topic (eg Industry 4.0, PAT Technologies, Post surveillance ) of the journal and some general detail on the topic in the context of validation in Pharma, biopharma or medical device as appropriate.
b. Summary of the article – (2-3 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 organized, including 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 to write 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 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 – (1-2 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. not your own specific knowledge but that in the field of validation i.e. why is this research important to validation in general.
e. Conclusion – (2-3 paragraphs) Compare the findings presented in this paper with your own experience in your work environment – relevancy, ease of adoption, not relevant to your organization & 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 that you had to research relative to your evaluation