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Tuesday, April 10 • 3:30pm - 5:00pm
Session F- GLP Track

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F-1  EPA Regulatory Update 

F-2  Quality assurance auditing of analytical data in support of GMO crops development and production 

A genetically modified organism (GMO) has been produced by genetic engineering techniques.  Its genetic material has been altered to express one or more genes for novelty traits.  A common application of GMOs is in the agriculture and food industry where transgenic crops may offer selective advantages, such as resistance to insects or pathogens, herbicide tolerance, higher yields and increased nutritional values.  GMO testing laboratories develop and validate specific methods to fit the purpose of measuring certain new characteristics in diverse and complex plant matrices.  From a quality perspective, data should meet the well-known requirements of integrity, reproducibility, repeatability, accuracy, specificity, and traceability.  Quality assurance faces the new challenge to define and implement procedures to ensure that the measured analytical attributes are representative of specific transgenic events.  Compared to an environmental residue analysis, a typical auditing process for analytical GMO studies requires management of an increased amount of data complexity and variability.  Quality assurance auditing needs to verify that a standardized data interpretation is applied, so that the data produced is a consistent indicator of the genetic novelty.  A reliable quality system should include performance checks and indicators to guarantee that the overall GMO crop development and production process does meet current quality standards.  This presentation reviews the key aspects of auditing data measuring attributes in genetically modified crops and underlines how data quality translates into product quality.


Level of Content:


Eva Haszcz

Gloabal Quality Programs Manager, FMC Corporation, Agricultural Solutions
Ms Haszcz has 17 years of experience working in GLP and GMP regulated environments. Since 2009 she is the Global Quality Programs Manager within the Regulatory Department at FMC Corporation. Through her work in a global regulatory setting she has gained an extensive understanding... Read More →

avatar for Laura Ricci Daye

Laura Ricci Daye

Quality Assurance Auditor, knoell USA, LLC
Laura Ricci Daye is a Quality Assurance Auditor at knoell USA in the Research Triangle Park in North Carolina. Laura earned her MS in Molecular Biology from the Third University of Rome with a thesis work on the characterization of Nicotiana tabacum and Arabidopsis thaliana transgenic... Read More →

Mark Lehr

Mark Lehr entered the environmental industry working as an environmental consultant. He conducted technical and scientific work related to Resource Conservation and Recovery Act (RCRA) permitted facilities and various National Priorities List (NPL) sites which included performing... Read More →

Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 5&6