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Statistical Considerations for ICH Guidelines

8/4/2014 8:30 AM - 8/5/2014 4:30 PM

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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.

Course Outline:

Day 1 – Agenda

Lecture 1: Introduction/Fundamentals - Statistics

• Summary Statistics

• Graphical Techniques

• Hypothesis Testing

• Confidence Intervals and Tolerance Intervals

• Interactive Discussion/Questions

Lecture 2: ICH "Q" Series

• Q1 Stability Testing

• Q2 Validation of Analytical Procedures

• Q3 Impurities in New Drug Substances

• Q5 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human of Animal Origin

• Q6 Specifications

• Q7 GMP for API

Day 2 – Agenda

Lecture 3: Statistical Tools in Action (Workshop)

• Developing a Risk Management Plan

• Assay Validation

• Setting Specifications

• Q8 Pharmaceutical Development

• Q9 Quality Risk Management

• Q10 Pharmaceutical Quality System

Lecture 4: Integrating Statistics

• Regression - Q1

• Design of Experiments and ANOVA - Q8

• Sample Size - Q6

• Probability - Q9

• Interactive Discussion/Questions

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


Steven Walfish

President, Statistical Outsourcing Services

Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.

Location: Sydney, Australia Date: August 4th & 5th, 2014 Time: 8:30 AM to 4:30 PM

Venue: Hilton Sydney 488 George Street, Sydney, Australia 2000

Address: Hilton Sydney 488 George Streets, Sydney, Australia 2000

Price: $1,595.00


Register now and save $200. (Early Bird)

Until July 10, Early Bird Price: $1,595.00

from July11 to August 02, Regular Price: $1,795.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302-288-6884




Event Link:


161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

Learn More: Statistical Considerations for ICH Guidelines

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