Test Method Validation through the Test Method Lifecycle; Understanding the U.S. FDA and the EMA Guidance Documents and Why they Stress the Product Lifecycle Concept

Live, Interactive Training Webinar

Date: Tuesday July 31, 2018 Time: 9:30am - 11:30am ET
Instructor: Jerry Lanese Ph.D. Biography>>>

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The method development analyst often has the paradigm that test method validation is a single event that occurs just before a firm submits an NDA, ANDA, or other application to a regulatory agency. This paradigm is encouraged by U.S. and international guidances that state test methods used during drug development need not be validated. It is also a contradiction to other guidance statements requiring that methods used for drug product release be compliant with GMPs and be scientifically sound. The paradigm also ignores the need to monitor test methods to verify they continue to perform as intended.

During the last few years the U.S. FDA and the EMA issued guidance documents for product production process validation that have emphasized the product lifecycle concept. A test method is a process and the concepts expressed in the production process validation guidance apply to test method validation. The U.S. process validation guidance defines process validation as: “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process.” It is appropriate that personnel involved with the development and routine use of a test method consider the concept of the test method lifecycle, how this concept applies to organizations, and systems that should be put into place to support the test method lifecycle concept.

Test method development occurs simultaneously with product and process development and the test method is used to monitor product quality attributes and generate data that demonstrates that the performance of product production process. Therefore, the scientists should have data that demonstrates the test method is scientifically sound – that it performs as intended throughout the product and method development stage of the method lifecycle. This is supported by a statement in the process validation guidance: “analytical methods (used during product-and process-development activities or when used in characterization studies) should be scientifically sound (e.g. specific, sensitive, and accurate)”. The method life-cycle concept will drive a re-evaluation of the industry paradigm that test method validation is a formal, one-time experiment occurring just before the firm submits an application to the regulatory agency.

In this live training webinar we will discuss the test method lifecycle and how concepts discussed in the process validation guidance apply to test method validation.

Learning Benefits:
-How the FDA is emphasizing process understanding as an important part of the product lifecycle.
-How the lifecycle approach impacts test method development and validation.
-How the three stages of process validation apply to test method validation.
-The importance of understanding the intended use throughout the method lifecycle.
-The application of measurement uncertainty and process capability.

Webinar outline and time breakdown:

09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Background to method validation,
The new millennium – a transition,
Test method lifecycle – Stage 1 – Method Design and Development,
10:30 AM Break
10:40 AM Test Method Lifecycle – Stage 2 – the Formal Method Validation,
Test Method Lifecycle – Stage 3 – Continued Verification,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A Copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Senior management
  • Production management
  • Quality management
  • Quality Assurance
  • Quality Assurance Product Reviewers
  • Regulatory

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Instructor: John G. (Jerry) Lanese Ph.D.

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… Full Bio>>>



Course Number: 270

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