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23 2013

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

Syndicated from: Canadian Youth Business Foundation

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 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: Website: LIVE CHAT SUPPORT ALSO – GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA For More Info Click Here:

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