ComplyFDA Presents: Baseline Assessment

Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to ensure robust solutions. I found this analysis extremely insightful and wanted to share it with you:

In the video, Michael explains how these baseline assessments are designed to be time-saving and cost-effective, typically completed in 3-4 days, sometimes in as little as 2 days. The process begins when a customer experiences unwanted quality process risks, identified through various internal and external inputs.

By evaluating the quality process against current FDA trends and regulatory risks, the baseline assessment delivers a streamlined evaluation, providing an overall risk score. This score drives actionable improvement recommendations that integrate validated best practices, elevating the performance of the quality process and significantly reducing regulatory risk.

 

I also wanted to thank Michael once again for sharing his insights, and for the opportunity to work together and combine our expertise in quality and compliance!

For More Information

For more information on Michael Kuehne and ComplyFDA, please visit their website at: ComplyFDA.com

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