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Microbiological Control in a Pharmaceutical Manufacturing Environment

November 4, 2019

Part 1: Microbiological environmental monitoring data and establishment of alert and action levels

This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data. We will review microbiological trending and how it can assist in understanding what is significant in each particular situation. The discussion will cover how the analysis of this trended data enables a company to establish alert and action levels as methods for determining these levels.


Part 2: Pharmaceutical Environments Cleaning Validation Programs and Associated Disinfectant Studies

We will review cleaning validation protocols, methods, and procedures to evaluate and define a robust program to protect your products, personnel, and equipment.  We will discuss correlating disinfectant validations with the trending of routine-environmental monitoring data to establish a compliant program in a clean room environment.


Part 3: Water Quality; Water Impurities, Purification Methods, Validation, and Process Controls

Water is perhaps the most extensively used raw material in pharmaceutical manufacturing. Its use as an inactive ingredient, active pharmaceutical ingredient (API), analytical reagent, and even as a solvent in cleaning processes, leads to potential product and environmental contamination from residual water impurities. This presentation addresses the removal and control of microbiological and chemical impurities in a quality water system.