Quality Assurance, Clinical Trials and Regulatory Affairs

INSTRUCTIONS

You are to provide a critical evaluation of two research articles related to Process Analytical Technology (PAT), Quality by Design (QbD) and/or analytics of quality in pharmaceutical industry, and present a paper critique assessing the chosen articles as an oral presentation, which would be followed by questions (20 minutes in total).

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You should plan carefully the structure and content of the presentation before writing. Although there is no limit to the number of slides or diagrams to be presented, you are strongly recommended to practise your presentation to fit within a 15-minute time frame.

The presentation must demonstrate your own critical analysis on the appropriate research papers selected. It is important that you present your information appropriately and clearly to support your discussion on the chosen topic.

You should include the following in your presentation:

Background information of your chosen topic

The reasons for selecting the two journal articles for discussion

Critical evaluation of the selected journal articles, in terms of the analytical methods used (and alternatives that could be used), results and conclusion

Complete bibliographical details in Harvard format

Total of 15 slides needed. Sample document attached