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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 Developing a risk strategy Course Outline: Day 1 – Agenda Lecture 1: Introduction/Fundamentals - Statistics Summary Statistics Graphical Techniques Hypothesis Testing Confidence Intervals and Tolerance Intervals Lecture 2: ICH "Q" Series Q1 Stability Testing Q2 Validation of Analytical Procedures Q3 Impurities in New Drug Substances Q4 Pharmaceutical Development Q5 Quality Risk Management Q6 Pharmaceutical Quality System Day 2 – Agenda 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 Who Will Benefit: Quality Managers Assay Development Scientists Quality Analysts Research Scientists Risk Managers Quality Managers ABOUT SPEAKER – Mr. Steven Walfish brings is the founder and President of Statistical Outsourcing Services. He brings nearly 20 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University. Location: Boston, MA 3rd & 4th April 2014 9:00AM-6:00PM EDT Venue: Courtyard Boston Logan Airport Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until March 10, Early Bird Price: $1,295.00 from March 11 to April 01, 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 LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php Event Link: http://bit.ly/Klaxl7 GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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ICH Q guidelines, pharmaceutical Conferences, biotechnology Conferences, Boston Conferences, Steven Walfish conferences, Statistical Conferences,
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