Validation is the process of performing a set of experiments that reliably estimates the efficacy, reliability, and reproducibility of an analytical method. The goal of conducting validation experiments is to establish evidence which demonstrates that a method is capable of successfully performing at the level of its intended use and to identify the method’s limitations under normal operating conditions.
This webinar will start with a brief overview of the ASB and how standards are developed within the organization. This will be followed by a discussion of the requirements of ANSI/ASB Standard 036 and will include the key topics of a) establishing a validation plan based on the intended use of the method, b) designing experiments for critical validation parameters (bias and precision, calibration model, interferences, limit of detection and limit of quantitation), c) how to efficiently conduct validation experiments, and d) knowing when revalidation is needed. The webinar will then provide further guidance on a critical aspect of validating quantitative methods: selection of the most appropriate calibration model. This will be followed by a demonstration of one laboratory’s application of ANSI/ASB Standard 036 into their quality system. Then an overview will be provided to show how ANSI/ASB Standard 036 aligns with the requirements of accreditation programs in forensic toxicology. The live webinar will end with a panel discussion and opportunity for questions from the participants.
Overview of ASB and ANSI/ASB Standards – Teresa Ambrosius (5 to 10 minutes)
Overview of ANSI/ASB 036: General Requirements of Standard – Marc LeBeau (45-60 minutes)
Selecting the Right Calibration Model for Your Quantitative Method – Brigitte Desharnais (45-60 minutes)
Real World Application of ANSI/ASB 036 – Rebecca Wagner (30-45 minutes)
The Link Between Accreditation Requirements and ANSI/ASB 036 – Melissa Kennedy (30-45 minutes) Q&A Panel (30 minutes)