GlobalCompliancePanel, Courtyard Boston Logan Airport,225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
2014-01-23
Overview: This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical or 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.
Who Will Benefit: Quality Managers Assay Development Scientists Quality Analysts Research Scientists Risk Managers Quality Managers Areas Covered in the Session: Introduction to ICH Q Series Introduction/Fundamentals - Statistics Integrating Statistics into protocols Developing a risk strategy Course Outline: Day 1 – Agenda Lecture 1: Introduction/Fundamentals - Statistics Summary Statistics Graphical Techniques Hypothesis Testing Confidence Intervals and Tolerance Intervals Lecture 2: ICH "Q" Series Q1 Stability Testing Q2 Validation of Analytical Procedures Q3 Impurities in New Drug Substances Q4 Pharmaceutical Development Q5 Quality Risk Management Q6 Pharmaceutical Quality System Day 2 – Agenda Lecture 3: Integrating Statistics Regression - Q1 Design of Experiments and ANOVA - Q8 Sample Size - Q6 Probability - Q9 Interactive Discussion/Questions Lecture 4: Statistical Tools in Action Developing a Risk Management Plan Assay Validation Lecture 5: Setting Specifications Location: Boston, MA| 23rd & 24th January 2014 |9:00AM-6:00PM EST Venue: Courtyard Boston Logan Airport Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA Price: $1,295.00 Register now and save $200. (Early Bird) Until December 10, Early Bird Price: $1,295.00
from December 11 to January21, Regular Price: $1,495.00
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