Online Webinar 2019 - Live Webinar Analytical Method Validation

Overview
This webinar explains the best practices of analytical method validation, and also provide practical tips on how to validate an analytical method under the GLP requirements, and It is recommended for laboratories that are under, or want to be under, GLP.
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.
Session Highlights
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
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.
John G. Lanese
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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry