Permissible Changes Under USP Methodology to Use Recent IC Innovations

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  • Date: Mar 17, 2015 - 15:00 - 16:00 (local time)
  • Presenter: Joe BurgeThermo
  • Categories: Ion Chromatography
thumbnail image: Permissible Changes Under USP Methodology to Use Recent IC Innovations

Permissible Changes Under USP Methodology to Use Recent IC Innovations


Broadcast on March 17, 2015

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Laboratories that produce contract analytics for customers under FDA regulations are very limited by acceptable analytical columns and mobile phase choices when performing ion chromatography (IC). While new IC innovations allow faster, more reliable results with less operator intervention, working in compliance with USP monographs and customer method requirements pose unique adoption challenges. Additionally, the availability of software validation and compliance to ensure data integrity is extremely important to these laboratories who are working under audit scrutiny.

Given these challenges, Microbac Laboratories will discuss the benefits of using a Thermo Scientific Dionex HPIC system which demonstrates ease of use, flexibility, and configurability for compliance testing. Microbac Laboratories will also discuss the benefits of the user-friendly Thermo Scientific™ Dionex™ Chromeleon™ Chromatography Data System (CDS) which has a full audit trail feature and allows instrument qualification testing. The latter allows automated testing and reporting which is usually a laborious manual process for a Metrologist.

Key Learning Objectives

  • Learn about permissible changes under USP methodology to use new advances in IC
  • Optimizing USP monographs for assay and impurity analyses
  • Learn about easy to operate IC systems with modern software control using electronic submission, review, reporting and qualification

Who should attend?

  • Pharmaceutical analysts performing ion chromatography
  • Instrument maintenance personnel that would be interested in learning how software control and instrument qualification may be used in a FDA regulated environment

Your Presenter

Joe Burge

Joe Burge

Microbac Laboratories

Joe Burge: Biography

With a Bachelor’s degree in Chemistry from the Miami University of Ohio, Joe Burge is a Metrologist for Microbac Laboratories. Joe started doing instrumentation metrology work for Microbac Laboratories in 2007 and is now responsible for maintaining the LC/IC lab instrumentation in a GMP/ISO environment. His current position involves utilizing software validation, reporting, and ensuring compliance with regulatory agencies.

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In association with:
                                 Pittcon 2015                             Current Protocols

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