Using Statistical Methods for ICH Guidelines: 2-day In-person Seminar
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Keywords: Design of experiments, Analysis, Probability, Statistics, Biotechnology, Design, Technology, Business
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.
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
Course Outline:
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
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:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
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Using Statistical Methods for ICH Guidelines: 2-day In-person Seminar to be held from 23 janeiro 2014 to 24 janeiro 2014 in Courtyard Boston Logan Airport, Estados Unidos. It covers various areas of Não classificadas including Healthcare. For more information, visit the website of the conference or contact the organizer.
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