Analytical Method Validation in FDA process - 2017

Overview:

• Product Id : 501215
• Instructor : Jerry Lanese
• Tuesday, April 25, 2017   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 90 Minutes

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 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. In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations. Dr. Lanese lectures throughout the world on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and national seminar and conference providers. 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. Jerry is a member of the Editorial Board of the Journal of GXP Compliance. He has been active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for the past fifteen years. He has served as Examiner, Lead Examiner and Judge and is currently the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. Dr. Lanese is also a member of American Society for Quality, AOAC and the Institute for Management Consultants and is a Certified Management Consultant (CMC). He is listed in Madison Who’s Who. He was active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for seventeen years. He served as Examiner, Lead Examiner, Judge and the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. On the personal side, Jerry is active in two Toastmasters clubs in the Johnson County, KS area, and is the president of Kansas City Ragtime Revelry, an organization that promotes ragtime and early American music.

Others Details

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