Test Method Validation Basics - Ensuring Adequacy and Reliability of Your Test Methods

Poor test methods that have not been properly validated can cost your company tens of millions of dollars, besides your much costlier reputation. There was a case of this only recently, when a protein test method for heparin was not fully validated by a prominent drug manufacturer. The heparin was found too late to be contaminated with fatally toxic substances and had to be recalled, after many lives had been lost as a result.

Test method reliability, precision and accuracy are fundamental performance characteristics of analytical methods used in the pharmaceutical and medical device industries. Test Method Validation is thus critical to the design, development, production and release of pharmaceuticals and medical devices. Test methods that are inadequate, ineffective and incorrect can result in significant test errors that could affect product safety, effectiveness, purity, consistency and performance. This online training will guide you through the basics of avoiding such consequences.

Areas Covered in the seminar:

• The elements of test method validation.
• Precision and accuracy of test methods.
• The limit to detection and quantification.
• Specificity, linearity and range.
• Robustness, repeatability and reproducibility of test methods.
• Calibration and Preventive maintenance.
• Life Cycle of Method Validation.

Who will benefit:

This webinar will be of value to all those involved in analysis and testing, design and development, engineering, quality and manufacturing.

• Analytical test lab managers, technicians
• Quality managers, engineers and technicians
• Technology / engineering
• Manufacturing managers and engineers

Instructor Profile:

Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.

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