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Biopharmaceutical Analytics: Regulations and Validations

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Overview / Abstract:

This 2-day accredited training will begin with teaching basic regulations to build a foundation of how a compliant lab and strong systems should be built. The course will then examine methods and attributes that need to be in place prior to qualification and validation activities. Once the stage is set, method qualification and validation will be the main topic of the course. Additional topics will also be discussed such as transferring methods, what validation work needs to be done on compendial methods, how to perform a proper lab investigation, when a method needs to be revalidation or qualified, method trending, and FDA reviews.


May 03, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

Rachel Monsef, Consultant to the pharmaceutical and biopharmaceutical industries

Keywords / Search Terms

CfPA Biopharmaceutical,l Analytics, Regulations, Validations, compendia, FDA, Quality Control, Quality Assurance, Analytical Scientist, Research Associates, Product Development, Manufacturing, Validation Seminar CE CME

LIVE Activity Location Details

05-02-2018 - 05-03-2018

Amsterdam, The Netherlands

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