This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant differences in data. Participants will gain insights into microbiological trending and its role in understanding the significance of variations in specific situations. The session will discuss how analyzing trended data enables companies to establish alert and action levels, as well as the methods for determining these levels effectively.
Viewers will learn about the protocols, methods, and procedures for evaluating and defining a robust cleaning validation program. This program is essential for protecting products, personnel, and equipment. The webinar will cover the correlation between disinfectant validations and the trending of routine environmental monitoring data, emphasizing the importance of establishing a compliant program in a clean room environment.
A critical part of the presentation will address the use of water in pharmaceutical manufacturing. As the most extensively used raw material, water serves multiple purposes: an inactive ingredient, an active pharmaceutical ingredient (API), an analytical reagent, and a solvent in cleaning processes. The webinar will explore the potential risks of product and environmental contamination from residual water impurities. It will provide strategies for the removal and control of microbiological and chemical impurities within a quality water system.
By the end of this webinar, viewers will have a thorough understanding of how to evaluate microbiological and environmental monitoring data. They will learn how to use trending data to set appropriate alert and action levels and establish robust cleaning validation protocols. Additionally, participants will gain insights into maintaining a high-quality water system to prevent contamination in pharmaceutical manufacturing. This session is crucial for quality assurance professionals, regulatory affairs specialists, and anyone involved in maintaining clean room environments and ensuring the safety and efficacy of pharmaceutical products.