2-day In-person Seminar on Using Statistical Methods for ICH Guidelines at Barcelona, Spain

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 facts 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.

Areas Covered in the Session:

·         Introduction to ICH Q Series

·         Introduction/Fundamentals - Statistics

·         Integrating Statistics into protocols

o    Regression - Q1

o    Design of Experiments and ANOVA - Q8

o    Sample Size - Q6

o    Probability - Q9

o    Interactive Discussion/Questions

·         Developing a risk strategy

Who Will Benefit:

·         Quality Managers

·         Assay Development Scientists

·         Quality Analysts

·         Research Scientists

·         Risk Managers

·         Quality Managers

Agenda

Day One:

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

·         Q8 Pharmaceutical Development

·         Q9 Quality Risk Management

·         Q10 Pharmaceutical Quality System

Day Two:

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

Instructor Profile:

Steven Walfish

President, Statistical Outsourcing Services 

Mr. Walfish is a Principal Statistician at BD in Franklin Lakes, NJ. He is responsible for supporting continuous improvement efforts and process development for worldwide operations. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI. Previously, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the 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. 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. Steven has experience applying statistical methods to design control verification and validation. Steven has been part of three 510(k) submission and numerous meetings with the FDA.
 

Venue: Hilton Barcelona Hotel

Venue Address: Avinguda Diagonal, 589-591, 08014 Barcelona, Spain

Price: $2,095.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until April 30, Early Bird Price: $2,095.00

From May 01 to June 06, Regular Price: $2,295.00

Registration Details:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 1 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/Using-Statistical-Methods-for-ICH-Guidelines-at-Barcelona-Spain