The Influence of recent FDA and USP activities on Test Method Validation

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 120 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."

Lifecycle approach to test method validation

Description

Since the requirement for test method validation appeared in the GMPs in 1978 the industry has considered that test method validation is a one-time event in the life of a test method. This concept was supported by interpretations of USP Validation of Compendial Methods first published in the 1980s and ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology, which was finalized in 2005. The pharmaceutical industry, as all industries, is now taking a more proactive view of all processes and has adopted a lifecycle approach to process understanding and validation. The FDA issued a guidance on process validation, Process Validation: General Principles and Practices, in 2011 which advocated a lifecycle approach to process validation. The lifecycle concept was applied to test methods in recent USP stimulus article and there is now a move to apply the lifecycle approach to test methods. The life-cycle approach will put more emphasis on a clear definition of the intended use of a test method and the uncertainties associated with a test method. 

In this webinar, we will discuss the lifecycle approach to test method validation and how it might impact the practice of method validation from the decision to develop a test method through to the discontinuation of the use of the method for the testing of a commercial product. 

This ninety-minute webinar will begin with a review of the USP Stimulus Article, Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification along with the FDA 2011 Process Validation Guidance and a discussion of how these apply to and impact test method validation. Key elements of the discussion will be the three stages of test method validation, the importance of the Analytical Target Profile and an understanding of measurement uncertainty. 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.

Since the requirement for test method validation appeared in the GMPs in 1978 the industry has considered that test method validation is a one-time event in the life of a test method. This concept was supported by interpretations of USP Validation of Compendial Methods first published in the 1980s and ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology, which was finalized in 2005. The pharmaceutical industry, as all industries, is now taking a more proactive view of all processes and has adopted a lifecycle approach to process understanding and validation. The FDA issued a guidance on process validation, Process Validation: General Principles and Practices, in 2011 which advocated a lifecycle approach to process validation. The lifecycle concept was applied to test methods in recent USP stimulus article and there is now a move to apply the lifecycle approach to test methods. The life-cycle approach will put more emphasis on a clear definition of the intended use of a test method and the uncertainties associated with a test method. 

In this webinar, we will discuss the lifecycle approach to test method validation and how it might impact the practice of method validation from the decision to develop a test method through to the discontinuation of the use of the method for the testing of a commercial product. 

This ninety-minute webinar will begin with a review of the USP Stimulus Article, Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification along with the FDA 2011 Process Validation Guidance and a discussion of how these apply to and impact test method validation. Key elements of the discussion will be the three stages of test method validation, the importance of the Analytical Target Profile and an understanding of measurement uncertainty. 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.

Objective

This webinar will help the personnel in the Test Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving practice of test method validation. The paradigm that test method validation is one experiment that is performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of: Test Method Procedure Design (development and understanding), Test Method Procedure Performance Qualification and Continued Test Method Procedure Performance Verification. Further, It is important that the organization and the analyst understand the uncertainties of the test method, and therefore the reported results.

This webinar will help the personnel in the Test Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving practice of test method validation. The paradigm that test method validation is one experiment that is performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of: Test Method Procedure Design (development and understanding), Test Method Procedure Performance Qualification and Continued Test Method Procedure Performance Verification. Further, It is important that the organization and the analyst understand the uncertainties of the test method, and therefore the reported results.

Areas Covered

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
Specificity
Accuracy
Precision
Linearity
Range
Limit of detection

Who will Benefit

•     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.

Industries who can attend

This 120-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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