Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.
This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.
This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Cleanroom classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be discussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.
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