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_____ Brought to you by Waters _____

Leachables: Method Optimization and Validation in Routine Testing

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  June 5, 2018

  8:00 a.m. PDT / 11:00 a.m. EDT / 16:00 BST / 17:00 CEST

 

Overview

 

In this webinar we will discuss a solution for the transition to, and the execution of, the routine testing portion of Extractables & Leachables study programs. As testing transitions into QC laboratories, regulatory requirements increase, and methods must be proven to be fit for their intended purpose, and a higher focus on data integrity must be observed.

We will discuss data integrity considerations, how to have more confidence in data, how to make method transfer easier, and why mass detection is an important tool for routine testing in the QC laboratory.

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Key Learning Objectives

  • Why Extractables & Leachables product testing is done
  • The Extractables & Leachables testing workflow
  • Advantages of using a Chromatography Data System which allows for the creation of tailored calculations for AET and automatically flags results which exceed the AET
  • Advantages of using MS detection for increased confidence in peak identification and ease of use when connected in series with a PDA detector

Who Should Attend

  • Anyone in Pharma QC
  • Anyone doing routine monitoring of polymer additives in manufacturing
 

Speaker

Neil Lander,
Principal Product Manager, Informatics,
Waters Corporation
 

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