Using Statistical Methods for ICH Guidelines: 2-day In-person Seminar

·         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

·         Quality Managers

·         Assay Development Scientists

·         Quality Analysts

·         Research Scientists

·         Risk Managers

·         Quality Managers

Course Outline:

·         Summary Statistics

·         Graphical Techniques

·         Hypothesis Testing

·         Confidence Intervals and Tolerance Intervals

·         Interactive Discussion/Questions

·         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

·         Regression - Q1

·         Design of Experiments and ANOVA - Q8

·         Sample Size - Q6

·         Probability - Q9

·         Interactive Discussion/Questions

·         Developing a Risk Management Plan

·         Assay Validation

Lecture 5: Setting Specifications

Speaker Profile:

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. Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M), Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been a speaker at ASQ Division and Section conferences. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine

Date, Venue and Price:

Location: Boston, MA

Date:23rd & 24th January 2014  

Venue: Courtyard Boston Logan Airport

Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA

Price: $1295.00

Discount for One Delegate and Group Participants:

Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00

From December 11 to January 21, Regular Price: $1,495.00

Contact Information:
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