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Examination of Proposed Manufacturing Standards and Implementation of ISO 18385

Kristina received her Bachelor's Degree in Genetics from the University of Wisconsin in Madison. She has worked in the Manufacturing area of Biotechnology for over 20 years and has a Master’s Certificate in Project Management and is a Six Sigma Green Belt. Currently, she supervises the team of scientists that manufactures and QC tests the Human Identification product line at Promega Corporation.

Kristina has been actively participating in discussions with ASCLD as well as international groups regarding the proposed Forensic Grade draft ISO standard for forensic reagent manufacturers. For the last year, she has been leading the efforts, at Promega, to study the feasibility and impact of implementing this standard on the manufacture of forensic reagents and consumables.

  • Ms. Kristina Pearson

  • Production Manager, Genetic Identity

  • Original Webinar Date: Thursday, April 30, 2015

Promega recently held the webinar "Examination of Proposed Manufacturing Standards and Implementation of ISO 18385". In this webinar, we discussed the suitability of two methods (STR testing or a combination of STR testing and qPCR) in a manufacturing workflow for the purpose of certifying a product as Forensic Grade.

Information

Download the PDF to see a presentation of latest updates on the initiative within the Human Identification market to enable "Forensic-Grade Certification" of products. Forensic DNA laboratories rely on reagent and plastics manufacturers to supply high-quality products with minimal interference from contaminating DNA. With the increasing sensitivity of short tandem repeat (STR) amplification systems, levels of DNA that were previously undetected may now generate partial profiles.

We discussed the suitability of several methods in a manufacturing workflow for the purpose of certifying a product as Forensic Grade.

The presentation will discuss studies to evaluate proposed parameters including:

  • Sensitivity difference between qPCR and STR analyses
  • The suitability of qPCR and STR analyses for testing different product types