Analytical Method Validation

Jerry Lanese
Jerry Lanese
90 Minutes
Product Id:
6 months

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Price Details
$189 Recorded
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An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory. It is important that all analysts, method developers as well as the Quality Control analysts, understand the requirements for analytical method validation and the implications of the characteristics that must be considered for Analytical method validation.

A recent USP Stimulus Paper demonstrated the importance of identifying the Analytical Target Profile. This stimulus paper and the 2011 FDA guidance on process validation emphasize the importance of a clear understanding of the Analytical Target Profile early in the test method lifecycle and make it clear that test method developers and quality control laboratories must demonstrate that the test method continually performs as intended throughout the method lifecycle. This webinar will discuss method validation requirements through the test method lifecycle: method development, the formal method validation and continued use of the method for routine testing.

Areas Covered in the Session:

  • FDA System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • Warning letter observations and analysis

Who Will Benefit:
  • Quality Control Manager
  • Supervisors
  • Analysis and Microbiologists

Speaker Profile
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries.

He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers.

Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, "GXP Talk" in the Journal of GXP Compliance.

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