I need a 15 minute presentation based on the file that I have uploaded which is a case study
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This presentation focuses on assessing manufacturing deviations within the Bakostar production process, highlighting sterility assurance evaluations and addressing compliance through CAPAs. It introduces the product-specific protocols, analyses risks like microbial contamination, and emphasises the consequences of deviation, including batch rejection. Employing educational methodologies such as FMEA and sterility control evaluation, it recommends corrective actions and process...