The objective of this two day 'Essentials of USP Microbiology' seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include USP <51>, <61>, <62>, <71>, <1072>, <1111>, <1112>, <1113>, <1116> and others. Various team exercises will be conducted to allow the participants to use these USP documents to solve 'real life' problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar.
Who Will Benefit:
Microbiology plays a role throughout the manufacture of pharmaceutical products. Whether the final product is non-sterile or sterile, the bioburden exists from the raw materials, throughout the process and/or within the product's environment (water and HVAC) to the final product. A critical review of the overall microbiological process will determine whether the critical 'in-process' points permit the final product to meet its acceptance criteria. In addition, any 'objectionable' or 'specified' microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.
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