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

Event Details

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

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 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

Agenda

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
Venue: WILL BE ANNOUNCED SOON – Zip Code: 17200

Price: $1,595.00

(Seminar for One Delegate)

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