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2-day In-person Seminar on Using Statistical Methods for ICH Guidelines at Sydney, Australia

Event Details

2-day In-person Seminar on Using Statistical Methods for ICH Guidelines at Sydney, Australia

Time: June 11, 2015 at 9am to June 12, 2015 at 6pm
Location: Sydney, Australia
Street: Sydney, Australia
City/Town: Sydney, Australia
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Mar 10, 2015

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Event Description


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. 

Areas Covered in the Session:
  • Introduction to ICH Q Series
  • Introduction/Fundamentals - Statistics
  • Integrating Statistics into protocols
  • Developing a risk strategy
  • Quality Managers
  • Assay Development Scientists
  • Quality Analysts
  • Research Scientists
  • Risk Managers
  • Quality Managers


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:

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.

Location: Sydney, Australia        Date: June 11th & 12th, 2015        Time: 9 AM to 6 PM 
– Zip Code: 17200


Price: $1,595.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until April 30, Early Bird Price: $1,595.00

From May 01 to June 09, Regular Price: $1,795.00

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  

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