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Contact : Mr. D. L. Pandya
Classic Computer Services
B-4, Mandir Appt., Opp. P & T Colony, Jodhpur Char Rasta, Satellite Road, Ahmedabad-380 015. India.
Phone : +91 79 26740611 Telefax : +91 79 26754867
M : +91 9825457563
E-mail : mpds00@vsnl.com / dlpandya@gmail.com

Test Method Validation

July 18-19, 2017
Chicago, IL USA


Background : Test methods are one of the most critical elements in the design, development, manufacture and release of products. They provide the objective evidence for the safety and effectiveness of devices. It is thus imperative that device manufacturers ensure their test methods used in the determination of safety and effectiveness for their product are suitable, capable and reliable for their intended use. Inadequate test method validation can have severe regulatory and business consequences. In the past few years, regulatory bodies have added additional focus on test method suitability and reliability in their audits and inspections.

This two-day session will explain the intent and importance of test method validation with respect to the regulations and standards. The training will also provide participants the fundamental knowledge and tools to establish and implement effective test method validation procedures and processes. Hands-on, interactive exercises will be used to highlight the principles learned.

Objectives :

  • Understand the intent and purpose of regulations as it applies to test methods across the product lifecycle
  • Learn the basic principles of Test Method Validation to determine suitability and capability of the test method for its intended use
  • Understand the requirements for the qualification of test equipment
  • Understand requirements for calibration
  • Understand how to conduct a gauge repeatability and reproducibility (Gauge R&R) for variable data and attribute data
  • Learn the principles of method transfer
  • Lear how to develop and complete test method protocols and reports
  • Understand the validation life-cycle and changes to test methods

Winovia LLC
2435 N Sheffield Av, A8
Chicago, IL 60614-2277
(773) 348-8577

Dr Vinny Sastri, PhD
President, Winovia LLC