As a product proceeds through manufacturing to the API with the addition of various excipients, both non-sterile and sterile products (aseptic fill ‘n finish) must be tested for their microbiological content. With non-sterile products, a limited number of microorganisms are acceptable; with sterile products, no microorganisms may be present. Often issues of OOT, OOS and CAPAs become critical at this juncture point. Quality Metrics and their Risk Based implications of deviation related issues will be considered for both non-sterile and aseptically produced products. 

The objective of this live training webinar is to obtain an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist from the end of production through final release for both non-sterile and aseptic produced products. A review of Case Studies/Warning Letters pertinent to all phases of the microbiological release (microbiologist’s environment) will be reviewed to enhance the learning benefits. 

Learning Benefits:

• Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology within a fill ‘n finish environment 
• Review non-sterile products and how USP<61>, <62>, and <1115> impact these products and the number of microorganisms and species permitted in final products
• Review aseptically produced products and how the revised USP<1116> may impact any observed contamination within the Clean Room environment
• Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment 
• Review the use of metrics and risk management to assess problem solutions
• Case studies to include Form FDA 483s and Warning Letters 

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