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Webinar On "Method Validation and Test Method Lifecycle. The application of Lifecycle concepts to test methods"

Event Details

Webinar On "Method Validation and Test Method Lifecycle. The application of Lifecycle concepts to test methods"

Time: January 24, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map:
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Jan 20, 2018

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Event Description

Description :

Analytical Method Validation should be approached with a clear understanding of the intended use of the method in mind and an understanding of the application of the intended use through the lifecycle of the method.  The approach to Analytical Method Validation should be consistent with the concepts discussed in a recent USP stimulus paper and articles published in the USP since the concept paper.

Objective :
This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. The paradigm that test method validation is one experiment performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of: Analytical

This ninety-minute webinar will begin with a review of the USP Stimulus Article, Lifecycle Management of Analytical Procedures:The discussion will conclude with a review of the test method characteristics of accuracy, precision, linearity, range, specificity, limit of detection and limit of quantitation and the application of these characteristics through the test method lifecycle.
Areas Covered in the Session :

The following areas will be covered in this audio seminar.

  • The USP Stimulus article: Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification.
  • The three stages of test method validation:
    • Test Method Procedure Design (development and understanding)
    • Test Method Procedure Performance Qualification
    • Continued Test Method Procedure Performance Verification.
  • Analytical Target Profile
  • Test Method uncertainties
  • The Test Method Types
  • Test Method characteristics
Who Will Benefit:

The following individuals will benefit from this webinar.

  • Personnel who have responsibilities in laboratory operations, including Directors, Managers, Supervisors and line personnel.
  • QA, Quality Control and Method Development Directors, Managers and those involved with the development, transfer and use of test methods.
  • Personnel in analytical method development.
  • Quality Control Laboratory personnel.
  • Validation specialists.
About Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

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