CLEANING VALIDATION Detergent Chemistry, Analysis and Analytical Methods, What Regulators Expect

  Рет қаралды 4,507

Pharma Best Practices Webinars

Pharma Best Practices Webinars

Күн бұрын

About the Webinar
Cleaning validation in non-sterile pharmaceutical manufacturing is an ongoing task for the industry. Over previous years, some topics were discussed more than others. This presentation will focus on detergent / cleaning agent chemistry. We will look at analysis and analytical methods including visual inspection with a focus on cleaning agents. Also a discussion on the relevance of Nitrosamines related to detergents will be made.
The objective of this presentation is to understand what is currently expected to facilitate a state-of-the-art cleaning validation. This should give the participants also a better understanding of the risk-based cleaning validation approach.
About Thomas Altman
Thomas is a cleaning chemistry, cleaning process, cleaning validation and regulatory compliance subject matter expert. He is an expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is experienced in addressing regulatory inspection findings related to cleaning processes - and with implementing CAPA plans to prevent re-occurrence. Thomas has developed more than 1500 cleaning programs/ recommendations for pharmaceutical and personal care industries. Thomas contributed significantly to the ASTM E55 WK15778 Cleaning Process Development and Validation standard and published related articles as a co-author in “Pharmaceutical Engineering” as well as “Pharmaceutical Online” and “Biotechnology Online”. Prior to joining Ecolab, Thomas worked in the pharmaceutical and food industries.

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