Statistical Considerations for ICH Guidelines: 2-day In-person Seminar
Thursday, February 6, 2014 at 8:30 AM - Friday, February 7, 2014 at 4:30 PM (PST)
San Diego, CA
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.
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.
When & Where
At ComplianceOnline, we are focused on :
- 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, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.