Analytical Method Validation

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System."

Best practices of analytical method validation

Description

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.

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

  • 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

 

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

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

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