Cannabis, the plant that has been around for thousands of years and has been used for both medicinal and industrial purposes, i.e., food fuel fiber paper and medicine throughout the world. It was due to racism, politics and greed not due to evidence-based medicine that the plant was put into probation in 1937 In the United States of America and removed from the U S Pharmacopeia in 1942. Our bodies have multiple systems, yet most healthcare providers and people are not aware that an Endocannabinoid System exists, nor its function in homeostasis with health and wellness. The lack of education and misinformation  regarding cannabis has led to stigma and disparities that impact humanity. In this presentation I will describe what is cannabis, the history of cannabis and differences between hemp and marijuana. What is the Endocannabinoid System(ECS) and its impact on various systems. How imbalance or deficiencies in Endocannabinoids impacts diseases in people and pets and how supplementation with cannabis helps to ease one’s quality of life. In the past decade I have become actively involved as an educator, advocate and activist, with a mission to change the stigma regarding Cannabis and for the world to know about the Endocannabinoid system and I do it through education. Dr Uma Says that this “plant is for people, pets, the planet, for peace and for profit, one’s profit is your health and wellness.” Cannabis is a global solution for multiple problems that society faces today locally and globally. From the start to the end the cannabis plant has an impact on the planet The plant requires no pesticides, every part of the plant can create sustainable products for consumption for people and animals which will improve our lives and the future of the planet. Multiple products from food to cosmetics, to building material, to medicines, etc. The cannabis plant can be used to address  Global warming, climate change, disparities, diseases and safer alternatives, etc. Cannabis can impact our environment, the water, the soil and the air we breathe, and our world.

Learning Objectives:

1. Understand what the Endocannabinoid System is and how cannabis works with the Endocannabinoid System

2. Describe what is cannabis and the difference between hemp and marijuana

3. Understand the role of cannabis in medical and industrial products for global solutions

An essential tool in the modern laboratory, the Laboratory Information Management System is embraced for its utility to acquire and mine simple to complex data. The cannabis laboratories have come to rely on the LIMS to track and manage a given customer sample from the laboratory reception to sample destruction.  The regulatory environment broadens the overall sample management to include traceability of a sample from the time of its cultivation clear through to its customer purchase of a finished product on a dispensary shelf.  Known as “seed to sale”, the life of a cannabis plant or cannabis-derived material is long and circuitous where inconsistent or negligent management that could lead to license revocation.  The LIMS functionality is designed to address specific laboratory needs to ensure the cannabis sample handling has met all laboratory and regulatory accountability requirements, including ISO/IEC 17025.  This presentation will provide a useful overview of the applicability of LIMS in the third party testing laboratory from sample intake to disposal.  Of particular interest will be discussion on the LIMS role in quality control in attestation of the veracity of a test result before it is released to a customer.

Learning Objectives:

1. Identify multiple points where LIMS can maintain accountability to ISO/IEC 17025 document control requirements, Quality Control Requirements, and dissemination of data to third part regulatory bodies

2. Understand specific ISO/IEC 17025:2017 clauses that specify requirements for Laboratory Information Management Systems

3. Understand that LIMS is a tool and must be treated appropriately; it does not replace appropriate scientific discussion or interpretation

Approximately 1 out of every 3 children with epilepsy do not respond to conventional medications, resulting in significant disruption in quality of life.  The CDC states that one in 54 children suffer with autism, a heterogeneous neurodevelopmental condition with very few treatment options. For these patients and their families, safe and effective treatment options are a priority.  After the 2013 CNN documentary showing how CBD oil helped a child with a severe seizure disorder, interest in the use of cannabis to treat children with epilepsy and autism exploded.  In this presentation, I will discuss the scientific evidence supporting the use of cannabis for pediatric epilepsy and autism, and will share my experience treating over 1000 children with phytocannabinoids.  Benefits and risks of cannabis use in this vulnerable population, as well as dosing, product requirements, and legal issues will be discussed. I will also share "clinical pearls” and case reports from my experience treating these children.

Learning Objectives:

1. Understand the role of the endocannabinoid system in pediatric epilepsy and autism

2. Describe the scientific literature supporting the use of cannabinoids in the treatment of pediatric epilepsy and autism

3. Understand the benefits, risks, product requirements and legal issues related to the use of cannabis in the pediatric population

Accurate and reliable analytical cannabinoid potency data is essential to operating a compliant, consistent, and profitable cannabis company. Third-party testing labs service this industry need by offering testing as a service to cannabis companies. Since testing labs have a vested interest in the sustained success of their clients, successful lab-client relationships are usually more akin to a partnership than a simple service provider. Testing labs understand that supporting their clients throughout the cannabis product development lifecycle is mutually beneficial and endears their clients to their suite of professional laboratory services. However, third-party analytical potency testing at the levels required to sustain good manufacturing practices and to ensure the quality, consistency, and efficiency of manufacturing processes is extremely expensive. Additionally, the informational lag from the sampling-to-result turnaround time creates opportunity for costly process inefficiencies to linger resulting in lost profit margins on manufactured products or increased time-to-market. Supplementing confirmatory third-party potency testing with in-house potency testing significantly decreases the cost and lag time associated with obtaining the analytical information required to operate a successful cannabis business. This talk will focus on the testing needs of cannabis operations requiring high testing volumes such as processors and other vertically integrated businesses and multi-state operators. It will outline how in-house and commercial testing workflows can be aligned through the standardization of analytical hardware, cloud-based software, and sample preparation, analysis, and quantitation methods. A new collaborative testing model is described for democratizing cannabis potency testing, while expanding the professional laboratory services offered by commercial cannabis testing laboratories.

Learning Objectives:

1. Attendees will recognize the benefits of both commercial and in-house testing programs and will be able to identify when to use each.

2. Attendees will have the tools to assess costs associated with several different testing programs available to cannabis businesses.

3. Attendees will realize how commercial laboratories can utilize software to collaborate with in-house testing operations more effectively and create new laboratory service models for their clients.

The growth of the cannabis / hemp industries in the United States has been tremendous. Legalization efforts continue in many states with a consistent eye on Federal legalization.  As a gauge of demand and growth, the amount of acreage devoted to hemp growth according to estimates was in excess of 285,000 acres in 2020. Much like other industries, the understanding and application of analytical techniques to measure quality and safety of cannabis / hemp products will continue to evolve. It is a predictable occurrence that the supply chain will get more complicated. Developing and validating harmonized, standardized methods and specifications for cannabis / hemp is a priority for successful development and commercialization of consumer-friendly products. The purpose of this talk is to give a high-level overview of the analytical challenges the industry faces and how they relate to the market in general. Successful commerce depends on product confidence. the measurement and characterization of cannabis hemp products. This will form the framework for building consumer confidence.

Learning Objectives:

1. Gain a better understanding of testing technology

2. Gain a better understanding of statistical sampling and quality

The cannabis market is rapidly growing as legalization continues to increase across the United States and Internationally. As a result, an influx of different types of cannabis infused edibles and personal care products have come to market. From an analytical standpoint, it’s important to conduct purposeful method development so that your analytical method meets your objectives when performing potency testing. In this work, sample preparation strategies and potency testing methodology will be discussed for various sample matrices. A method that includes two newly discovered cannabinoid compounds, tetrahydrocannabiphorol (THCP) and cannabidiphorol (CBDP), will also be introduced. A general overview of sample preparation procedures will be reviewed and a deep dive into the method development for some samples that rely heavily on sample preparation, CBD infused lotions, balms, and creams will be presented.

Learning objectives:

1. Outline effective methodologies for potency testing flower, concentrates, and lotion, balm, and cream samples

2. Identify two recently discovered cannabinoids of interest and how to detect them

3. Implement sample preparation methodologies for a set of complex matrices- CBD infused lotions, balms, and creams

Cannabis testing laboratories play a pivotal role in today’s cannabis industry. These laboratories test a wide-ranging list of compounds, including cannabinoids, terpenes, and a multitude of contaminants. For a cannabis testing laboratory to be successful in providing accurate, timely, and quality results, an effective workflow is essential. The workflow outlined herein, will take the sample from receipt, through processing, data analysis, and reporting of results while incorporating all testing methodologies. Testing requirements and action limits are reviewed, including the implementation of the most current validated methods. As the cannabis industry continues to develop and grow, laboratories will need to adapt to changes in workflow, in order to maintain the highest standards in analysis as this industry evolves.

Learning Objectives: 

1. Outline the workflow of the cannabis testing laboratory, to include receipt, processing, data analysis, and reporting of results.

2. Identify cannabis testing requirements and related methodologies currently used.

3. Identify current challenges within the cannabis testing laboratory workflow and learn how to address them.

The use of medically unsupervised cannabis use is exponentially growing in the USA. Healthcare providers need to not only recognize this fact but embrace it with the goal of avoiding drug-drug interactions and improving therapeutic outcomes. The goal of this activity is to provide pharmacists and pharmacy technicians with real world experience in the use of cannabis in disease state management; discuss clinical case studies and the importance of knowing how formulation, active ingredients and route of administration impacts the onset of action, duration of action and therapeutic outcomes. Published data as well as personal experience treating over 3000 patients with cannabis in a Functional medicine clinic will be shared.

Learning Objectives: 

1. List the most common medical indications that cannabis is used for today 

2. Discuss the importance of knowing why the formulation and route of administration impacts the onset and duration of phytocannabinoid therapy

3. Discuss the value of cannabis as an alternative or adjunct treatments in chronic pain conditions with or without opiates

Currently in the cannabis industry, there are many different regulations and guidelines. From the federal level with the USDA and DEA, to each individual state, testing laboratories and their clients have many regulations to understand and follow. Not only do regulations differ from federal to state level, depending on the type of cannabis tested, marijuana or hemp, those regulations differ as well. The regulations and guidelines in the cannabis industry are rapidly changing. The purpose of this discussion is to educate on and discuss the current testing regulations and guidelines in the cannabis industry.  Attendees will be able to understand testing requirements on both a federal and state level.  Attendees will also be able to understand which states require ISO/IEC 17025 accreditation as a part of the testing laboratory licensing process and the benefits of ISO/IEC 17025 accreditation in the cannabis industry.

Learning Objectives:

1. General testing requirements for cannabis in the United States.

2. Benefits of ISO/IEC 17025 accreditation in the cannabis industry.

The purpose of the project was to provide a straightforward way to develop analytical methods for terpene analysis. Terpene analysis can be a difficult proposition and having a basic understanding of common issues and pitfalls can be hugely beneficial. There is a growing interest in terpene analysis as research expands into the exciting aspect of cannabis science. Terpenes are widespread throughout nature with thousands of individual compounds being present in nature. There are several hundred terpenes that have been found in cannabis flower. Terpenes are built from repeating units of isoprene and their designation is dependent on the number of isoprene units present. Due to the nature of these compounds, gas chromatography coupled with a mass spectrometer is the preferred method of analysis.

Learning Objectives:

1. Learn how to develop a analytical method for analyzing terpenes using gas chromatography

2. Learn how prepare samples for analysis and understand common pitfalls

The strong growth in cannabis has led to scaled challenges. As industry has experimented and grown, producers of cannabis oil, both CBD and THC, have started to regularly implement adsorption processes as regular production practice. Explore a high-level look at the landscape facing commercial cannabis oil production.

Learning Objectives:

1. Discuss specific growth areas in cannabis oil processing

2. Identify importance of overcoming manufacturing challenges

The utilization of high fidelity long read sequencing is critical for the resolution of repetitive genomes. Cannabis sativa is known to be diploid (2n=20), 70% repetitive, 64% AT rich and 1% polymorphic. The chemotypic genes (CBDAS, THCAS, CBCAS) governing cannabinoid synthesis are buried in multiple megabase LTR forests. High fidelity long read sequencers resolve these repetitive regions and enable genotypic classification of chemical expression. Pathogen resistance genes are equally important to the prediction of cannabinoid yield. Utilizing Pacific Biosciences HiFi sequencing, we construct reference grade genomes that enable population surveys of diverse chemotypes and pathogen resistant cultivars. We demonstrate the use of HiFi reads to resolve both complex medicinal plant genomes like Cannabis sativa L. and the rapid resolution of the medicinal fungal genome Psilocybe cubensis.

AOAC approvals benefit the cannabis industry by providing you third party independent validation to authenticate package insert claims and the test kit performance providing confidence and brand protection; methods may have enhanced performance to provide you confidence and brand protection while impacting product safety, integrity and public health.  AOAC is a leader in analytical excellence contributing to the advancement of product safety, product integrity, and public health.  AOAC has a long history of leveraging the power of many making to strengthen impact to fit for purpose methods through the development of standards methods.  Through Cannabis Analytical Science Program (CASP), AOAC influences cannabis science and cannabis safety impacting cannabis science and validation to bring reliable analytical test methods and method validations to ensure safety, science, and protect the industry, consumers, and products.  The validation process ensures five main elements are confirmed: matrix study, inclusivity, exclusivity, stability,  and robustness in both internal studies and independent studies.  Validation methods are publicly accessible. An AOAC method brings you and the industry third party independent validation to authenticate package insert claims, test kit performance to confirm scientific robustness and rigor to provide you confidence, consumer health and safety, and brand protection; methods may have enhanced performance.  AOAC methods demonstrate robust and reliable science and expand the cannabis industry.

Learning Objectives:

1. Who is AOAC and how do they ensure and impact cannabis science and safety

2. The value of AOAC certification for the cannabis industry and what this means for you, the industry, and the impact on sate required validations

From seed to sale, from accurate cannabis potency profiles to reliable, highly sensitive pesticide analysis, the Cannabis and Hemp industries have a demand for robust testing that delivers defensible data.  In this webinar, we present the latest technologies used to analyze every aspect of cannabis and hemp to assure highest quality.  In addition to the most recent advances in chromatographic and spectroscopic methods for determination of potency (cannabinoids) terpenes (the sweet scent of sativa), pesticides (from farming), residual solvents (from extraction), metals (from soil), mycotoxins (from air), and water activity, we also describe how to measure another critical quality parameter: texture of edibles.  Texture is a critical characteristic in the perception of consumers for cannabis and hemp edibles, like gummies, and must therefore be controlled and measured to assure a consistent consumer experience.

Learning Objectives:

1. Understand the importance of a robust QC program for cannabis and hemp quality

2. Explain the latest analytical techniques used in QC of cannabis and hemp

3. Expand the scope of quality testing to include texture of edibles

Most Cannabis testing laboratories perform a variety of tests, full analysis for production QA/QC, and contract commercial testing, while others focus on extraction or purification only, or research. With the legalization of Cannabis in Canada, and growing acceptance in the US for medicinal as well as recreational use, testing is becoming a critical component in ensuring product quality.  ISO 17025 Certification is a requirement for Cannabis testing laboratories, along with many other state and federal requirements. Other organizations that are manufacturing products such as CBD or THC also need to understand and comply with Good Automated Manufacturing Practices (GAMP). In order to effectively manage the increasing volume of data and information, Laboratory Information Management Systems (LIMS) are a necessity. Beginning with sample accessioning and workflow management LIMS can manage system access along with analysts’ permissions and privileges. This is important, as regulated laboratories are required to provide evidence of the training and competence of the analysts that are performing the analysis for specific tests. Their training records and certifications must be provided and updated as required. The LIMS will track any changes to results in an audit trail, to ensure that the data has not been manipulated. Any changes to results (the majority will come directly from the instrument) will be documented – the system will hold the original result, the new result, the date and time stamps for each, along with the analyst information and a reason that the result was changed. This process provides a high level of data integrity. The LIMS can also “force” peer review. This means that the person that entered a result cannot be the person that validates and approves that result. Many of these LIMS features help to enforce regulatory compliance with ISO 17025 as well as other GALP (Good Automated Laboratory Practices) and GAMP requirements. There are so many functions that LIMS can manage and enhance over manual systems; many that are not directly associated with result data. These includes managing chemicals, supplies, and reagents (used in the testing), and their associated expiration dates, lot numbers, CoAs, safety sheets and along with vendor information. LIMS not only organize sample workflow (with positive ID) and result data (along with automated instrument data uploads), but also calculations that can be validated and locked. This presentation will also examine the growing use of sensors in the laboratory for temperature, humidity, light, etc. and will highlight the integration with the LIMS for meeting the requirement for daily temperature monitoring of the incubators, refrigerators, and freezers in the laboratory. Streamlining laboratory operations (instrument integration, calculations, temperature monitoring, automated alerts for out-of-specification products) and eliminating mundane tasks are critical to ensuring the production of high-quality data, improving productivity, maximizing resources, and increasing efficiency, thereby increasing profitability.

Learning Objectives:

1. Learning key LIMS functionality which can be expanded with automation

2. Understanding key ISO regulatory requirements that Cannabis laboratories face

3. Gaining insight into how automation and LIMS can help Cannabis laboratories to achieve compliance

Over the past few years there has been an increased interest in the role of cannabis for treating medical conditions. Attitude towards cannabis has evolved rapidly with the expanding legalization of hemp and medical and recreational marijuana across various states. The variability of cannabis and hemp based products, along with limited research due to schedule 1 classification of marijuana and CBD in the United States has restricted medical professionals' understanding and acceptance of these products for patient use.  These shifts in cannabis use require clinicians to understand conflicting laws, health implications, and therapeutic possibilities. An adequate understanding of both legal and clinical issues is essential for optimal intervention.

Learning Objectives:

1. Learn of potential benefits of marijuana and CBD for patients

2. Be familiar with possible adverse effects and drug interactions

3. To review the current evidence and consider additional research needed to support the therapeutic use of THC and CBD

As the cannabis analytical market matures so do the requirements for quality assurance testing. This presentation will include an introduction to proficiency testing and how it applies to the cannabis analytical space along with an overview of the typical quality assurance tests that are performed and why. Current PT program and test options will be reviewed in addition to providing insight on the data collected, how it benefits the cannabis industry and can influence the regulatory environment.

Learning objectives:

1. What is an analytical proficiency test and why are they important

2. What are ISO 17025 requirements and how do they apply to proficiency testing

3. How can ILC/PT data be used to improve individual analytics and understand how the cannabis testing industry is performing as a whole

Too often, cannabis labs are trying to open for business without the solid foundation of an ISO management system. This afterthought is detrimental to labs’ short and long term success as they struggle to produce reliable results and gain stability. Labs that begin with a quality mindset open doors for business quicker and generate sustainable revenue and profit. A quality business model depends on a logically structured management system that addresses how the laboratory operates and delivers accurate and reliable test results. With quality as a business plan and model, every decision is made within the context of delivering accurate and reliable test results. What is the scope of activities the laboratory wants to undertake? What instruments have those capabilities? What competency of staffing is required to operate those instruments? Which consumables? Within a structured management system, these questions, and more, will be answered leaving no doubt about the lab’s future success.

Learning Objectives:

1. Identify the common mistakes in planning and operating Cannabis Test Labs

2. Identify the risks of poor-quality control to the public, producers and laboratory

3. Explain how a business plan and model, based on an ISO 17025 management system, can help labs avoid the common mistakes and mitigate risks

ISO/IEC 17025:2017 is an international accreditation used to standardize the practices of cannabis testing laboratories. ISO/IEC 17025 accreditation adds credibility to cannabis testing laboratories and assures the reliability of test results reported by them. Some of the requirements of ISO/IEC 17025 compliance are as follows.

Structural Requirements: Cannabis testing laboratories must define their management structure and document all activities for which it claims conformity to the standard.

Resource Requirements: Cannabis testing laboratories must ensure proper training of analysts and documentation of the training records.

Process requirements: Cannabis testing facilities must record all data related to test method validation, including the validation procedure, validation results, and a statement on the validity of the method for the intended use.

Management Requirements: The management requirements include controlling documents and tracking their revision history, addressing customer complaints, and documenting corrective and preventive actions taken.

Role of a Cannabis LIMS in Achieving ISO/IEC 17025 Compliance

An informatics solution, such as a cannabis LIMS, can help laboratories in complying with several requirements of ISO 17025 compliance. It helps track every gram of each sample from seed to sale. A cannabis LIMS helps manage all internal and external documents. It maintains training records of analysts and helps assign analytical tasks only to the competent staff. A LIMS helps schedule equipment calibration, records calibration and maintenance data, and prevents the use of outdated instruments.

A LIMS can be integrated with analytical instruments for bi-directional data transfer, ensuring data integrity and reducing turnaround time. A cannabis LIMS helps in generating CoAs as per customer and state requirements. A LIMS brings in standardization, efficiency, and enables third-party cannabis testing laboratories to stay ahead of the curve.

Learning Objectives:

1. An overview of the ISO/IEC 17025:2017 standard and the various requirements of the standard

2. The role of a LIMS in prepping cannabis testing laboratories for audits

Terpenes are a broad class of chemicals that are found throughout the Cannabis plant that produce the unique aroma and taste of your favorite variety. Cannabis breeders have been selecting for suites of terpene synthase genes for centuries without necessarily understanding the underlying genetics, until more recently in our history. In this talk, I will present an overview of the terpene synthase gene family, a general understanding of how the known terpene synthase enzymes work, and how these combinations of genes can help us predict the smell, taste, and effect of a given Cannabis variety. With over 55 genes identified in the literature (Allen et. Al., 2019), competing for common precursor molecules, such as GPP, FPP, and GGPP, which then can be enzymatically converted into multiple terpene products, in different tissues. We can now see the complex dynamic of multiple enzymes producing multiple product profiles that all contribute to the diverse smell, taste, and effects that Cannabis is known for. At Front Range Biosciences, our chemistry, breeding, molecular biology, and genetics teams work closely with one another to discover these genes in the genome, identify the function through in-vitro assays, and then validate the activity and inheritance of these genes while breeding and characterizing our diverse germplasm. By the end of the talk, I hope to convey the complexity of this gene family as well as the potential of what is possible through our work in Cannabis genetics.

Learning Objectives:

1. Understand what a terpene is and how they are created by plants

2. Understand the diversity and promiscuity of the terpene synthase gene family

Genetics may influence experience with cannabis and CBD. With increased access to legal cannabis and the research community expanding their focus on the medicinal uses of cannabinoids, more and more consumers are seeking cannabis for health and wellness. However, cannabinoids are extremely complex partners for our endocannabinoid system and research tells us that users can have vastly different physiological responses to individual strains or products. This makes it almost impossible to find a perfectly aligned product through trial and error. The truth is, cannabis is personal, and uncovering true endocompatibility for each individual user can be scientifically validated.

Learning Objectives:

1. Introduce listeners to the complexities of the endocannabinoid system and the role DNA plays in optimizing cannabinoid experiences

2. Discuss the breakthrough scientific approach Endocanna Health has taken to solving for an individualized response to cannabinoids

3. Address the significant barriers that both consumers and medical professionals experience when incorporating cannabinoid therapeutics into treatment protocols (safety, efficacy, consistency)

4. Discuss the latest research and scientific evidence to evaluate and confidently use cannabinoid therapeutics for individually defined optimal outcomes

5. Explain the scientifically based, genetically focused resource that consistently and reliably matches individuals with the most compatible cannabinoid products