Statistical Considerations for ICH Guidelines
This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines.
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
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
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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.