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Statistical Considerations for ICH Guidelines

Visit this Event

(www.complianceonline.com)

Course Description
This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.

This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

Topics covered will include:

The Ten ICH “Q” Series Guidelines
Statistical tools commonly used in industry
Applying statistics to Guidelines
When statistics are inappropriate
Learning Objectives:

Upon course completion participants will be able to:

Perform Regression Analysis
Know the difference between confidence intervals and tolerance intervals
Calculate the appropriate sample size
Calculate the probability of risk
Perform Process Characterization for Design Space
Compare FDA requirements to ICH guidelines

Who will benefit

All Development, Quality and Research Scientists from regulated industries will benefit from this training.

Quality Managers
Assay Development Scientists
Quality Analysts
Research Scientists
Risk Managers

21 comments
kristinhodgkin

Tags

ICH Guidelines, Integrating Statistics, Statistical Tools in Action, complianceonline seminar

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