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2day Inperson seminar on Using Statistical Methods for ICH Guidelines at Boston MA

1/23/2014 9:00 AM - 1/24/2014 6:00 PM


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


Mr. Steven Walfish brings is the founder and President of Statistical Outsourcing Services. He brings nearly 20 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302-288-6884




Event Link:


USA, Livermore Common, Fremont,

CA 94539, USA Phone: 1800 447 9407

Learn More: 2day Inperson seminar on Using Statistical Methods for ICH Guidelines at Boston MA

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