Environmental monitoring continues to be a regulatory focus in 2008, with numerous 483s having been issued to firms facing difficulties managing this critical quality systems function. By meeting both regulatory and quality issues in environmental monitoring, companies can be assured in the quality of their finished products.
This live and comprehensive web seminar will discuss facility validation, including facility design, personnel flow, equipment flow, baseline monitoring and quality control. The tracking and trending of data points will also be reviewed, with a focus on the best approaches and practices to employ when conducting EM. FDA warning letters related to microbiological issues will be covered, with an emphasis on how to avoid these 483s. Finally, a case study will be presented to demonstrate the most effective methods to use when performing investigations.
Learning Benefits: Learn about global regulations requirements for EM Review the various EM guidelines Understand the best processes to track and trend your data Evaluation of EM automation systems Gain knowledge on key validation issues with EM programs Obtain in-depth information on the benefits of risk analysis
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