Vitale Scientific Associates Hires Industry Expert to Spearhead Cannabis Services Program

Shannon Swantek joins Vitale Scientific Associates, LLC (VSA) as a Senior Quality Scientist with extensive knowledge of the environmental and cannabis industries.  She has a robust regulatory background that includes 8 years of experience performing audits nationally to the 2009 TNI1 Standard and ISO 17025:2005 Standards in environmental, food, agricultural, and cannabis laboratories.

Ms. Swantek was the Cannabis Program Manager for the Oregon Environmental Laboratory Accreditation Program (ORELAP), the state accreditation body required for all compliance cannabis laboratories in Oregon, and provided cannabis laboratory compliance training to state cannabis regulations and the 2009 TNI Standard.  She developed a cannabis-specific “in-matrix” proficiency testing program and multiple policies addressing the complexities of compliant implementation.  She trained the ORELAP Team on auditing, testing, and sampling of cannabis and organized the audits of 22 cannabis laboratories as an ORELAP Lead Assessor.

Ms. Swantek is uniquely qualified to perform the cannabis-related services offered by VSA.  An overview of those services is provided below.

Cannabis Services Overview

  • Laboratory management, inter-laboratory program management, analytical program design and management, sampling and analysis planning, and quality assurance (QA) project planning needed to meet state and local regulations.
    • Auditing and mock audits
    • Assessments
    • Training
  • Development of cGMP/ISO 9001-compliant Integrated Management Systems for extract and cannabis-product processors.
  • Performance of due diligence, compliance, and gap audits of processors, laboratories, and sampling organizations to various ISO standards, cGMP requirements, and state regulations.
  • Analytical QA and quality control (QC), including working under regulatory standards.
  • Laboratory facility planning, design and construction oversight.
  • Laboratory operational readiness reviews (ORRs) in preparation for state medical marijuana testing program requirements.
  • Management of laboratory procurements including drafting and issuing technical specification manuals; design, planning and execution of performance evaluation (PE) studies; and the evaluation of laboratory proposals.
  • Laboratory data review and data validation.
  • Analytical method development and validation.
  • Chemical, microbiological, and physical testing analytical experimental design, management, and evaluation of laboratory studies involving medical cannabis products, cannabis-infused products, finished plant material, cannabis resin, cannabis concentrates, cannabis oils, environmental grow media, water sources and other materials.
  • Experimental design, management, evaluation of laboratory studies in the cannabis industry for the following:
    • Cannabinoid Profile Testing for Major and Minor Cannabinoids
    • Terpenoid Profile Testing for Major and Minor Terpenoids
      • Monoterpenoids, Sesquiterpenoids and Flavonoids
    • Testing for Natural Contaminants and Adulterants
      • Pesticides, metals, residual solvents, microbes (bacteria and fungi) and growth enhancers
    • Testing for Degradation Products and Artifacts
      • Cannabicyclol- (CBL-) type phytocannabinoids, Cannabinodiol- (CBND-) type phytocannabinoids and other synthetic cannabinoid-like compounds
    • Analytical characterization of drug compounds and drug products.
    • Beyond-use dating (BUD).

We are proud to have Ms. Swantek on our team.  During her time at ORELAP, she also participated in ORELAP efforts to promote cooperative, rather than punitive, assessments in air toxics, environmental, drinking water, whole effluent toxicity, radiochemistry, and microbiology laboratories by providing technical assistance and cooperative training.  This holistic approach resulted in the program doubling in size, and ORELAP became the primary accrediting body to laboratories from South Korea, Fiji, Canada, and various states including Colorado, Arizona, Hawaii, and most laboratories in the California National Environmental Laboratory Accreditation Program (NELAP).

Ms. Swantek served on the Cannabis Testing Rules Advisory Committee (RAC), which advised on the testing legislation for both the Oregon Health Authority (OHA) for medical cannabis and the Oregon Liquor Control Commission (OLCC) for adult-use cannabis sampling and analysis.  She chaired the cannabis sampling sub-committee and participated in the pesticide sub-committee providing associated sections of the legislation.

As a cannabis industry expert, she assisted the Oregon Department of Justice (ODOJ), Oregon Department of Agriculture (ODA), OHA, and OLCC by regularly advising on policy in all parts of the cannabis-industry legislation pertaining to testing, labeling, processing, and cultivation.  She participated in industry education efforts – speaking at processor, dispensary, and cultivator meetings on the changing legislation, working with the laboratories, and educating on process control.  She also coordinated with other state public health officials in an effort to standardize state efforts and spoke on state regulatory panels in industry conferences such as the Emerald Conference and the Cannabis Quality Summit.  She remains engaged in state and national efforts to support the cannabis industry as well as provide laboratory development services to help elevate the industry’s standards for credible and high-quality scientific data.

For more information on VSA’s Cannabis Services, contact Shannon Swantek at 865.376.7590 ext.806.

1 The NELAC Institute