Cannabis Quality Conference & Expo

Tuesday, October 1, 2019

2:00 PM - 3:00 PM Cannabis Opening Plenary: Cannabis Certifications Panel

3:00 PM - 4:00 PM Cannabis Labs Accreditation Panel

4:00 PM - 5:00 PM Cannabis in the Midwest: A Panel Discussion

5:00 PM - 6:30 PM Welcome Reception Wednesday

October 2, 2019

8:30 AM - 9:00 AM

Breakfast Refreshments

9:00 AM - 9:45 AM Cannabis Quality Conference Keynote Breakout

10:00 AM - 10:45 AM Challenges and Best Practices in the Cannabis Industry in the United States and Canada The cannabis industry is in a unique place to learn best practices from established cannabis businesses, FDA-regulated facilities and Canadian companies. The presentation will provide current examples of procedures in the cannabis industry. The last two years have been an adventure for me to learn about the cannabis industry domestically and internationally. I networked at multiple conferences, visited dispensaries from Florida to California in my travels, and read a cross-section of materials from legislation to company websites. Through a series of targeted conversations with members of the cannabis industry, I asked questions to learn about individual jobs at individual companies, about challenges in their roles, and training needs across the cannabis industry. In my journey, I learned that the cannabis industry does not have to reinvent the wheel and can follow the rules for the FDA-regulated industries of tobacco, cosmetics, pharmaceuticals, dietary supplements or food. I heard that employees want the highest level of professionalism and standards for the cannabis industry. I see that Canada has followed the United States for the safety of food, and I hope the United States will follow the lead of Canada in the descheduling of cannabis and provide federal regulation of cannabis products. My presentation will include observations and lessons learned from operating facilities in the United States and Canadian cannabis markets, my expectations for the next year, and my hopes for the long-term future of the cannabis industry. Speakers: Kathy Knutson, Ph.D.

10:00 AM - 10:45 AM Critical Parameters for Cannabis Analytical Methods As medicinal and recreational cannabis continues to become increasingly legalized across the globe, there has been a rapid increase in the quantity and variety of cannabis-related edible/inhalable consumer products. With little in the way of standardized analytical methods, cannabis producers and testing laboratories have taken on the task of developing accurate and reproduceable analytical methods for quality control of these products, considering both purity (pesticides, fungal toxins, elemental impurities) as well as the product’s potency (cannabinoid and terpene profile). This presentation will discuss the critical parameters to consider when developing a chromatographic method for cannabis quality control. We will discuss column selection and column chemistry, mobile phase considerations, and how select and prepare high quality certified reference materials. Speakers: Michael Hurst

10:00 AM - 10:45 AM Federal and State CBD Regulations: Food and Dietary Supplements The 2018 Farm Bill removed industrial hemp from The Controlled Substances Act by creating a subcategory of the cannabis plant with one very important distinction - that it contain less than 0.3 percent THC on a dry weight basis. The change in law took industrial hemp out of the purview of The Drug Enforcement Agency (DEA), but assigned a large regulatory role to The United States Department of Agriculture (USDA) for implementing a federal program for the commercial production of hemp, and explicitly preserved the duties of The Food and Drug Administration (FDA) for regulating products that may hemp or its derivatives per The Food Drug and Cosmetic Act (FDCA). Both the USDA and FDA have started to address the regulatory complexities around a product that was just recently removed from Schedule I of the CSA, there is still a lot of confusion in the market, especially since CBD and hemp products are so readily available on the market. While the USDA is creating regulations to update the current growing programs that were developed under the 2014 Farm Bill and the FDA is gathering information and deciding how to regulate food, drugs, and cosmetics containing CBD, many individual states have taken it upon themselves to create various regulatory frameworks for growing hemp and deciding its legality in foods and dietary supplements. So far, this has created a patchwork of regulations that vary from state to state, and that range from outright prohibition in foods and dietary supplements to full permission. Needless to say, the regulatory environment for hemp and CBD is quite confusing, and continuously evolving. It is important to be familiar with the regulations to avoid running afoul of both federal and state regulations. There are general guidelines to follow as the new regulatory framework is created and implemented at both the federal and state level, and this presentation will present common issues around growing, imports, processing and labeling. Speakers: Eric Edmunds

10:45 AM - 1:45 PM Exhibit Hour

12:30 PM - 1:30 PM Lunch Breakout

1:45 PM - 2:45 PM Certification of Food, Beverages and Natural Health Products containing THC and/or CBD Various geographical jurisdictions have or will be creating regulations that enable the use of Cannabis and Cannabis related compounds to be introduced as ingredients or as concentrates into foods, beverages or natural health products. These regulations will merge with existing food regulations to create the framework of ensuring safety and quality products being sold into commerce. The supply chains and ultimate buyer and retailers of these products will vary as will the contractual agreements between the various parties. Common place among these contacts is the requirement to be certified to a food safety standard. The most prevalent of these standards in the food & beverage space are those benchmarked to the Global Food Safety Initiative (GFSI). Retailers, manufacturers and food service companies are supporting this as are some regulatory authorities. The SQF Food Safety Codes are a series of codes of practice that are GFSI benchmarked and can be applied an ultimately certified by accredited 3rd party certification bodies. The standard of choice and the scope of that certification will be dependent of the types of products and processes at the site or location being certified. The credibility and independence of the certification is paramount to the supply chain acceptance of companies and their products. This presentation will review the various industry sectors where THC and CBD can be introduced, the appropriate standards or codes to apply and how companies and sites can contract with SQF licenced certification bodies to complete certification. Training and other resources will also be introduced as well as the various aspects and the layout of the SQF codes. The SQF codes cover primary production (growing, harvesting), manufacturing, storage & distribution and retailing. Speakers: Frank Schreurs

1:45 PM - 2:30 PM HPLC method development strategies for achieving baseline resolution of 17 cannabinoids The global cannabis industry is growing rapidly, with many countries and US states adding regulatory frameworks for medical and adult-use cannabis programs. Quality control is an essential component in protecting the health and safety of the consumer in this emerging market, and there is increasing demand upon cannabis testing laboratories for analytical determination of multiple cannabinoids. As regulations evolve, and as research interests in minor cannabinoids expand, it is important to have robust analytical methods in place that are capable of meeting those needs. With these concerns in mind, HPLC method development toward the baseline resolution of 17 cannabinoids is demonstrated. Different approaches to method development, depending on the goal of the analysis are discussed, including using speed of analysis as a means for changing selectivity to improve resolution of critical pairs as needed. Additionally, the resolution of a specific critical pair of THC isomers is optimized using a ternary mobile phase. Speakers: Melissa Wilcox

1:45 PM - 2:30 PM Lessons from the Experts: Tackling Quality & Consistency Challenges from Seed to Sale Learn from cannabis experts who address the challenges of quality and consistency of products day in and day out. Discussion will be focused on the best methods from growers to the manufacturers. As well as thoughts on how to address known challenges to success in the industry. Speakers: Michelle Hansen

2:45 PM - 3:30 PM Dissected: The Farm Bill & the FDA's Stance on CBD

2:45 PM - 3:30 PM ISO 17025 Accreditation: Preparing for Your Cannabis Testing Laboratory Audit Using Cloud-based LIMS The talk will highlight the quality, technical and management requirements of ISO/IEC 17025:2017 compliance and how a cloud-based Laboratory Information Management System (LIMS) can help cannabis testing laboratories in meeting the requirements of ISO/IEC 17025:2017 compliance. Speakers: Arun Apte

2:45 PM - 3:30 PM Mold Prevention and Remediation within the Cannabis Industry Mold is an ever-present obstacle within the cannabis industry. An outbreak at any point in the process could result in an entire crop being lost. Mold spores can easily pass via the air, plant to plant, and various other ways. The monetary and time ramifications are so extreme that it could place an entire facility in great financial harm. In order to prevent these issues from occurring, there are various methods that could take place that are both innovative and effective. With years of experience on decontamination and disinfection, Kevin Lorcheim is able to enlighten the audience on precautionary methods to prevent mold and mildew from seeds to the final product, and everything in between. Methods discussed will include chlorine dioxide gas, liquids, as well as ultraviolet light. Studies regarding lab studies on the effects of such measures on the chemical makeup of cannabis plants with also be discussed. Speakers: Kevin Lorcheim

4:00 PM - 5:00 PM The Future of the CBD Market - Panel Discussion

5:00 PM - 6:30 PM Reception Thursday

October 3, 2019

8:00 AM - 9:00 AM Breakfast Refreshments

9:00 AM - 10:00 AM Cannabis Plennary Breakout

10:15 AM - 11:00 AM A Comprehensive Sanitation Program for the Cannabis Facility As an essential part of Good Production Practices (GPP), the Sanitation Program Manual outlines procedures, methods and processes to control quality and safety hazards including, but not limited to, materials used for the construction of floors, walls and ceiling surfaces of the building based on the relevant regulatory requirements of the Safe Food for Canadians Regulations (SFCR), guidance on Food Safety Modernization Act (FDA), Food Defense (FDA) and Food Defense Awareness (FSPCA). The Sanitation Program is set out to describe: Pre-operational assessment and operational sanitation procedures; Procedures for effectively cleaning and sanitizing the premises in which cannabis is produced; Procedures for effectively cleaning and sanitizing the equipment used in the production of cannabis; Procedures for handling any substance used in the production of cannabis; Handle all requirements with respect to the health, hygienic behavior and the clothing of the personnel who are involved in the production of cannabis to ensure that activities are conducted in sanitary conditions. Speakers: Brigitte Tuekam

10:15 AM - 11:00 AM Cannabis Law 101: Past, Present, and Future The cannabis revolution has taken place with remarkable speed. In just 25 years, cannabis laws and attitudes throughout the United States have undergone a remarkable transformation. As recently as 1995, cannabis was illegal in every U.S. jurisdiction, and its use was widely taboo. The transformation began in 1996, when California voters passed Proposition 215, making California the first U.S. State to enact medicinal marijuana legislation. Since then, dozens of additional states have enacted medical, recreational, and hemp related programs. However, the federal government’s prohibitions remain largely in place. This has created significant confusion regarding cannabis, but also unique opportunities for businesses looking to enter the cannabis industry. This presentation will provide a broad historical perspective of cannabis law in the United States, explain how we got to where we are today, and use past events to predict where we are likely to be tomorrow. Speakers: Joel Chappelle

10:15 AM - 11:00 AM Tips and Challenges for Defensible Analysis of Pesticides in Cannabis Products As the cannabis industry becomes more regulated, analytical laboratories must generate data that results in their routinely passing regulatory audits. All analyses performed by the labs are challenging, but one of the biggest issues the industry faces is the analysis of pesticides.Pesticide analysis can be more challenging than other analyses due to low action levels, in parts per billion (ppb) or nanograms (ng). Other contaminant evaluations, such as residual solvents, often have action levels in the parts per million (ppm) or microgram (µg) range, which is 1,000 times greater than ppb. Other organics, such as terpenes and cannabinoids, are present at higher levels such that percent (%) or milligrams-per-gram (mg/g) are used.Heavy metal limits are also in the ppb range. The thorough digestion used in the analysis creates a more favorable signal-to-noise (S/N) environment in the inductively coupled plasma mass spectrometer (ICP-MS) than we see in LC-MSMS or GC-MSMS for pesticide analysis, where LC and GC are liquid and gas chromatography, respectively. Because there are only 92 naturally occurring elements, complete digestion of heavy metals allows for each to be measured accurately with little interference. In the analysis of pesticides, however, the number of interferences and similar compounds that may occur is extraordinarily high. This is why the technology used for pesticide analysis utilizes a series of mass filters to accurately detect analytes at trace levels. Speakers: Marco Troiani

11:15 AM - 12:00 PM Calibration & Traceability Myths and Misnomers “NIST-Traceability”, adjustment is the same as calibration, a calibration is good forever, “ISO 17025-certification”, there is one appropriate calibration method for any type of measuring equipment. These are all myths and misnomers. Language and understanding and use of correct terminology ease communication and can reduce mistakes and misunderstandings. This is of value to not only those in testing laboratories, but also for its customers and the consumer of cannabis products. Ensuring measurement traceability is an on-going practice and is critical to valid, repeatable, and defendable measurement data. Measurement traceability ranges from measurement equipment calibration, quality control, and sample tracking and test data reporting. What should be included in recording data to ensure measurement traceability? How can measurement traceability be ensured? To begin, measurements must be recorded. If they are not recorded with adequate detail, then one must assume that the measurement did not happen as there is no evidence to defend that it did happen.What determines a Pass or Fail in testing or calibration? Pass or fail is based on either qualitative or quantitative data.•In qualitative measurements, data are approximate, interpreted, characterized, and often expressed in text format. One may be comparing and matching colors, describing odor or bud composition. Qualitative data cannot be counted and therefore are not expressed in numbers.•In quantitative measurements, data are measured and expressed in a numerical format. One may measure and record sample weight, sample count, sample size, solvent use, etc. Think of quantitative data as something that answers questions such as “how many”, “how much”, and “how often”.Learning Objective 1: The attendee will learn up-to-date measurement terminology, including “calibration”, “traceability”, certification vs. accreditation.Learning Objective 2: The attendee will learn what measurement traceability is and means and how to ensure it.Learning Objective 3: The attendee will learn the differences between qualitative and quantitative data. Speakers: Heather Wade 1

1:15 AM - 12:00 PM HACCP Based Food Safety Systems: How do they relate to Cannabis Operations? Marijuana has been commonly used as a medical and recreational drug for several decades. The illegal status of the drug came to an end when California legalized its use for medical purposes in 1996. Legal recreational use started in 2012 when Colorado passed Amendment 64 and Initiative 502. Since the first legalizations more states have joined the revolution and have approved the agriculture, extraction, edibles manufacturing, cosmetic manufacturing, and product distribution for either medical or recreational uses or both. The main revolutionary aspect of Marijuana in terms of compliance is given by the fact that this drug, unlike any others that are made synthetically in a laboratory, is grown as an agricultural commodity, its components extracted and then used to infuse as ingredient in common foods and in cosmetics. So, what is the role of Food Safety in Cannabis manufactured products? Just like any other agricultural products, Cannabis is not immune to having hazards associated with it. As a result, regulations in several states have been driven to require the development and implementation of HACCP based food safety systems that requires hazard characterization and identification of preventive measures to eliminate or reduce such hazards to an acceptable level. California has called this approach a Quality Plan (Section 40253 – CDPH: DPH-17-010: Manufactured Cannabis Safety.) This presentation will be designed to provide a summary on how to create a HACCP based food safety system that allows you to comply with the current regulations. The compliance revolution is still in its infancy, there is more to come as the strides towards federal legalization continue. Therefore, the industry needs to prepare for more tighter and higher demands on HACCP based food systems from the Government soon. Speakers: Radojka Barycki

11:15 AM - 12:00 PM Tips & Tricks for branding, media and marketing a cannabis business This presentation will discuss issues in marketing, like challenges to protecting trademarks in content, social media, and customer-oriented products and services, with a focus on cannabis businesses. Speakers: David Adler, JD, CIPP/US

12:00 PM - 2:30 PM Exhibit Hours

12:00 PM - 1:00 PM Lunch Breakout

2:45 PM - 3:30 PM Don't Forget the Checks! How to Prep for Turning in Your Licensing Application

2:45 PM - 3:30 PM The Role for Accreditation in the Cannabis Industry Since the legal liability for producing an unadulterated and contaminate-free product ultimately rests with the growers, a legally defensible and consistent approach to quality assurance is paramount. In nearly all states where cannabis has been legalized for either medical and/or recreational use, accompanying regulatory requirements exist for ensuring that label claims and product quality are met through third party independent laboratory testing. However, unlike most other industries dealing with foods, medicines and consumed products that are regulated and controlled by the FDA, cannabis presents unique challenges because of a of regulatory inconsistency amongst states and Federal illegality. A solution that also creates legal defensibility and a baseline consistency can be achieved through the use of ISO/IEC 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories” (ISO/IEC 17025). This is because ISO/IEC 17025 is a globally accepted standard of quality for testing laboratories which aims to ensure a quality system is implemented to improve their ability to produce quality results. While conformance to a particular management system is often integral to the state recognition of the laboratory, each state however tends to approach this differently. Speakers: Roger Brauninger

2:45 PM - 3:45 PM Top Food Safety Hazards in the Edible Industry and How To Avoid Them Top Food Safety Hazards in the Edible Industry and How To Avoid ThemCourse content provided in the attached PowerPoint deck. Focus on top food safety hazards in the Edible's Industry and how to help manage and mitigate risk. Discussion on how integrated software such as an ERP system can help. Speakers: Daniel Erickson

3:45 PM - 4:30 PM Cannabis Closing Plenary