Newsletter | May 11, 2021

05.11.21 -- Research Collaboration To Develop Novel Patented Biomarkers Into Clinical Diagnostic Tests

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Featured Editorial

An Introduction To Trending In Environmental Monitoring Programs
		By Crystal M. Booth, PSC Biotech Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.

Establishing An Effective Calibration Program
By Mark Durivage, Quality Systems Compliance LLC Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

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