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July 27, 2017 - July 28, 2017

Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

Hyatt Place Miami Airport East, Miami, Florida

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Event Details

Begins: July 27, 2017

End: July 28, 2017

Event Location: Hyatt Place Miami Airport East, Miami, Florida

Website: http://www.globalc..34SEMINAR

Event Organizer

Event Organizer: Global Compliance Panel

Contact Person:

Phone Number: +1-800-447-9407

Website: https://www.globalcompliancepanel.com/

Overview

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.

In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are utilized, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how these guidelines are applied in practice.

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