Toll Free Number: 800-447-9407
Live Webinar on
Statistics for Quality Control and Process Validation: Linear Regression and Standard Curves Date: Wednesday, February 20, 2013
Time: 10:00 AM PST | 01:00 PM EST
Course "Statistics for Quality Control and Process Validation: Linear Regression and Standard Curves" has been pre-approved by RAPS as eligible for up to
Duration:
90 Minutes
Instructor:
Steven S Kuwahara
1.5 credits towards a participant's RAC recertification upon full completion.
Location:
Online
Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC
Register Now
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories.
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Overview: The use of linear regression is an often misunderstood area of statistics. It is basically a method for testing the relationship between an input set and the corresponding output. This webinar will discuss the application of linear regression procedures to the analysis of standard curves and similar types of data. There will be a brief coverage of the concept of covariance and its application to comparability studies for test methods.
Areas Covered in the Session: l
The basic concept of linearity and linear regression. Calculating slopes and intercepts.
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Covariance and comparability of test methods. Uncertainty in the slopes and intercepts. How flat is the line and does it really go to zero? Use of linear regression in a stability study.
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Who Will Benefit: l
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Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions. Development personnel who will develop tests and perform early stability studies. R & D personnel who will contribute data for use in
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development. Project managers for
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product development studies. Quality systems auditors
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Consultants.
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