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Live Webinar Stability Analysis – Q1E

May 14 @ 2:00 pm - 3:30 pm

Live Webinar Stability Analysis – Q1E

Register online

Dates Available

July 17, 2020

Time

2:00 p.m – 3:30 p.m.

Cost

CAD $385.00 + HST

Location

Online

Distinguished Speaker

Steven Walfish, President

Statistical Outsourcing Services

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.

Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

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.

Course Overview

ICH Q1E is intended to provide recommendation on how to use stability data collected using ICH Q1A. This webinar presents statistical methods and approaches for handling stability data. The webinar will provide insights into the current thinking on different shelf life conditions, poolability of lots, and matrixing and bracketing studies. Participants will leave with tools to handle most common stability trials and how to report the results.

Course Outline

  • Introduction to Q1
  • General Statistical Methods for Stability Testing
    • Linear Models
    • Pooling Lots
  • Extrapolation
    • Maximum Allowable
  • Estimating Shelf Life for Different Storage Conditions
    • Refrigerated
    • Freezer
    • -20°C
  • Accelerated Testing Models
  • Matrixing and Bracketing Analysis
  • New Method for Statistical Analysis

Note: Course outline is subject to change without notice. Please check back regularly for updates.

Who Should Attend

This 90 minute course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

  • Quality Assurance
  • Regulatory Affairs
  • Operations
  • CMC

Details

Date:
May 14
Time:
2:00 pm - 3:30 pm

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