Development, Validation, and Verification of Qualitative Methods Webinar
Recorded Webinar: Available in the SOFT Learning Center upon registration
Cost: $25/SOFT members; $35/non-members
Chairs: Dr. Brigitte Desharnais and Dr. Brittany Casey
Abstract
This webinar provides an in-depth review of qualitative method development, validation, and verification. Attendees will gain an understanding of some of the upcoming updates to the framework that governs qualitative method development and validation, ANSI/ASB Standard 036 (2nd Edition). The session will also explore how this unfolds in two specific techniques typically used for qualitative analysis: immunoassay and high-resolution mass spectrometry (HRMS). Insights into the implementation of these approaches in laboratory workflows will be provided. Finally, the use of a combined qualitative/quantitative method in a production laboratory will be discussed. This webinar is designed for professionals seeking to stay current with the evolving standards in qualitative forensic toxicological analysis, and those looking for guidance in the implementation of such methods.
Learning Objectives
1. Summarize some of the updates to ANSI/ASB Standard 036 (2nd Edition), and what this means for qualitative method validation requirements
2. Identify strategies for implementation and upkeep of qualitative immunoassay and high-resolution mass spectrometry methods
3. Describe the use of a combined qualitative and quantitative method, as well as its advantages and disadvantages
4. Identify potential improvements to a laboratory’s qualitative analysis framework
Schedule (Pacific Time)
11:00-11:30 am: Updates to ANSI/ASB Standard 036 (2nd Edition): Brigitte Desharnais, Scientific Coordinator – Development and Quality Assurance, Laboratoire de sciences judiciaires et de médecine légale
11:30 am-12:00 pm: Immunoassay: Denise Schiller, Responsible Person / Regulated Laboratory Manager, Drugscan
12:00-12:15 pm: Break
12:15-12:30 pm: Development of an HRMS qualitative method: Brittany Casey, Toxicology Team Manager, NMS Labs
12:30-12:45 pm: Optimization of HRMS data analysis parameters: Jennifer Colby, Scientific Director / VP Laboratory Operations, Premier Biotech
12:45-1:15 pm: HRMS method validation and maintenance: Stephen Trobbiani, Senior Forensic Scientist - Toxicology, Forensic Science South Australia
1:15-1:30 pm: Application of combined qualitative/quantitative method: Luke Rodda, Chief Forensic Toxicologist and Director, Forensic Laboratory Division, San Francisco Office of the Chief Medical Examiner
1:30-1:45 pm: Q&A: All speakers
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