E21-31: Cannabis Lab Essentials: Understanding the Cannabis Landscape and the Critical Process of Test Method Development and Validation

Tuesday, Nov. 16 & Wednesday, Nov. 17; 8:30am – 5:00pm

Dr. Susan Audino, S.A.Audino & Associates, LLC, Wilmington, DE

Day 1 of this 2 day course will include an overview of the cannabis landscape, covering cannabis history, processing, and current uses.  Day 1 will include the broad base of regulatory schemes for medicinal marijuana, recreational cannabis, and hemp and more importantly, discuss the base for third party testing Day 2 of this course will focus on currently available standard test methods and methodologies in place to address regulatory requirements, and then frame the general requirements for method development, method validation, and measurement uncertainty.

Based on the broadness of topic, either or both of these sessions should be attended by persons interested in the cannabis industry and in particular laboratory testing;  cannabis lab personnel who are responsible for method development.  Regulatory personnel may also find this class interesting and helpful.

  1. History of Cannabis
    a. Ancient Uses
    b. Legal  Use and Subsequent Prohibition in US
  2. Hemp
    a. Farm Bill and USDA
    b. Hemp
  3. Regulatory Requirements
    a. Constituents
    b. Contaminants
    c. Decision Rules
  4. Regulatory Challenges to Scientific Integrity
    a. Sampling
    b. Specifications/Regulatory Limits
    c. Matrix/Matrices
    d. Decision Rules (yep, again!)
  5. Test Methods
    a. Status of Published Standard Test Methods
    b. Method Verification vs. Method Validation
    c. Matrix Extensions
    d. Method Validation basic protocol
    e. Decision Rules
  6. Measurement Uncertainty
    a. Systematic
    b. Random
    c. Error
    d. Decision Rules

Dr. Susan Audino
is a chemist/chemometrician and independent consultant (S.Audino & Associates, LLC)  to chemical and biological laboratories.  She is an Analytical Chemist and chemometrician.   As a contractor for Accreditation Bodies, Dr. Audino assesses laboratories to and is an instructor for multiple ISO/IEC standards including ISO/IEC 17025.  Dr. Audino is on the Board of Directors of the Center for Research on Environmental Medicine and Board of Associates of Hood College. She is highly visible in the cannabis industry where she is a recognized leader for the development of official/consensus test methods and quality in cannabis laboratory science. She has been a member of technical expert review and advisory panels, currently serves as the Science Advisor to the AOAC International Cannabis Analytical Science Program (CASP),  advises several cannabis testing laboratories, private and non-profit cannabis organizations, and in 2021 joined the Analytical Cannabis Editorial Advisory Board. Dr. Audino has chaired the AOAC cannabis advisory panel and analytical cannabis working groups, was a member of the NCIA Guide for Laboratory Testing, has consulted to many organizations including regulatory bodies, and has been an invited speaker at numerous domestic and international scientific conferences. She has been on faculty at Teachable Medicine where she now serves as an advisor.  Dr. Audino is principal of multiple independent companies, has several patents pending and is a contributing author to Cannabis Laboratory Fundamentals to by published by Springer-Nature in early 2021.