2020 FDA Compliance Webinar Series | Ep. #2
On June 10, 2020, the team from Vanguard teamed up with Canna Advisors and Rymedi to once again welcome hundreds of guests from around the globe for another episode of our webinar series on forthcoming FDA regulation, and GMP compliance for domestic market and export-readiness in the hemp extraction, processing, and manufacturing industry...
Titled, PRODUCTIZATION FOR DOMESTIC & GLOBAL MARKETS, this second-in-series episode explored the ins-and-outs of managing the supply chain to produce formulated, retail-ready cannabis and hemp-based products.
The panel-format webinar featured leading North American and Global manufacturers of cannabinoid enriched products and ingredients, providing viewers the opportunity to ‘hear it from the field’ as the group unpacked some of the most high-barrier challenges the industry faces in the global expansion of cannabis-derived ingredients and formulated products. The webinar featured our hosts, Matthew Anderson (Vanguard Scientific ) and Dr. Jason Cross (Rymedi), along with panelists Andres Fajardo Luna (Clever Leaves), Will Corbitt (Avient Biosciences), and Jay Czarkoswki (Canna Advisors). The lively and engaging conversation explored topics including:
Supply-Chain requirements through the lens GAAP, GACP, cGMP and euGMP
Ingredient and Product Labeling Requirements for Global Off take Readiness
Product Market(s) Fit : Extraction Variances to Meet Consumer Demand
Understanding the CPG Buyer, Requirements and Restrictions
Identifying High-Performing Product Categories and Assuring Your Process is Flexible
Best Practices and Learned from Experience Process Discussions
During this session, you’ll hear high-level experts who are responsible for the success of multinational cannabis and hemp companies share the invaluable experiences and learning lessons that have helped some of the industries most successful businesses introduce cannabinoid products throughout the Americas and the European markets.
The effort, dubbed "FDA Future Proofing" centres around a four-part webinar series featuring star-studded casts of industry experts sharing actionable insights to prepare industry participants for success under federal regulation and export-focussed operation.
If you were in attendance, you'll surely be eager to know more about our speakers and their thought leadership. If you missed it, make sure you get on the pre-registration list for the next one, and take this opportunity to meet our panel and hosts (below).
Jay Czarkowski is an influential cannabis entrepreneur, investor, and advocate. A well-connected and respected industry insider, Jay and his team have helped build cannabis businesses in 30 states and internationally. As Founding Partner at Canna Advisors, Jay forges new avenues in the legal cannabis market with informed agility and strategic sophistication. A foremost authority on real estate development and cultivation design, Jay has held a commercial general contractor license since 2002. Working on multiple cannabis design projects throughout the U.S., Canada, and Puerto Rico, Jay focuses on highly automated, sustainable facilities with a niche in the greenhouse sector. Known for applying proven business tactics to unchartered territory, Jay has created a diverse vendor network at Canna Advisors with high-profile partners and serves on the board of multiple cannabis businesses. With a decade of regulatory experience as a consultant and award-winning operator, Jay has paved the way for innovative startups and technologies. He is dedicated to building the industry through successful and inclusive state programs, pairing grassroots advocacy with a global vision. In constant pursuit of new business horizons, Jay looks forward to shaping cannabis policy and growing the market internationally.
Jay is a Founding Member of the NCIA, a sustaining member of SSDP, and a Lifetime Member of the Arcview Investment Group. In 2016, he received the Arcview Group’s Outstanding Member award for his career service to the industry.
William (Will) Corbitt is the quality and compliance director for pharma-grade trailblazers, Avient Biosciences, a CBD extraction company based in North Carolina. As a seasoned quality systems and auditing professional, Will has more than four decades in GMP and FDA-compliant finished product packaging for companies ranging from startups to large, multi-site, multi-national biotech, pharmaceutical, and medical device companies, overseeing the production of all imaginable form factors. With a unique and thorough understanding of FDA regulatory landscape, Will’s vast quality systems and lean six sigma experience has seen him in roles ranging from CEO and quality director to head of compliance investigations, including work directly overseeing complaints, holds, rejections (OOS, and OOT), deviations, root cause analysis (RCA), CAPA’s, change control, quality audits, annual product reviews, manufacturing batch record reviews, and product final release. Mr. Corbitt has worked with the likes of Burroughs Wellcome, Glaxo Wellcome, GlaxoSmithKline, Pfizer, Novartis, Roche, Genentech, Bayer (now Grifols), Apotex, Cardinal Health and Regenxbio.
Andres Fajardo is an established leader and consultant who has worked with top management firms to solve key strategic issues across various industries. In his role as President and Chief Operating Officer at Clever Leaves, he has led the development of the company's GACP certified cultivation facility, the design and construction of a GMP certified extraction and formulation plant, and the development of a number of associated consumer brands. Prior to Clever Leaves, Andres was a Co-Founder & Managing Partner Founding of mojo Ventures, a unique late-stage company builder focusing on working with startups and small companies to achieve unprecedented growth and profitability. Before being an entrepreneur, Andres was President/CEO at IQ Outsourcing, a leading Colombian Business Process Outsourcing Firm that is part of the Sanford Group of Companies. Prior to joining IQ, Andres was a Principal Member at Booz & Company, a management consulting firm, based in Mexico City. Andres holds an MBA from the Harvard Business School, a B.S. in Industrial Engineering, and a B.S. in Economics from Los Andes University in Colombia.
Dr. Jason Cross (Ph.D., JD) is Co-Founder and Chief Strategy Officer for Rymedi, a technology company enabling healthcare companies to capture, track and share data with blockchain, IoT and AI. Prior to Rymedi, Dr. Cross was a professor of innovation and entrepreneurship law, policy, and business at Duke University, where he was founding Executive Director of the Innovation & Technology Policy Lab. At the ITPLab, he led the research, consulting, and venture incubation on novel finance, intellectual property, collaboration strategies, and trade policy for enhancing the efficiency and accessibility of innovations across global health, energy, education, and smart infrastructure. He has extensive experience working with governments, industry, and nonprofits to create and strengthen inclusive innovation systems: from biopharmaceutical legal reform and trade policy in Central America, open education business models and telecom policy in Southern Africa, and mHealth technology in emerging markets, to intellectual property and global development negotiations at the WTO, WIPO, and WHO. Dr. Cross earned his Ph.D. in the Anthropology of Economics & Governance from Duke University. He was a Postdoctoral Fellow in Science & Technology Policy at the University of Michigan’s Ford School of Public Policy and received a J.D. from Duke Law School specializing in innovation and intellectual property law. Dr. Cross also has an M.A. and passed Ph.D. exams in the History & Philosophy of Science from the University of Pittsburgh, and a B.A. in Biological Anthropology from the Pennsylvania State University.
Matthew is a true entrepreneur, having created Enlightened Grain Spirits, a nationally distributed spirits company out of his garage at the age of 22. With an unrelenting thirst for knowledge and an inspiring appreciation for the beauty of life, Anderson is a seasoned creative marketer possessing expertise within branding, industrial design, and advertising.
As a Partner at MacArthur Capital, LLP, Matthew has had ground-level work experience in the global cannabis industry since 2015. MacArthur, a private equity company, has deployed more than $30 million dollars into the industry throughout the areas of advanced cultivation, supply-chain design, contract manufacturing, and technology advancement. Anderson’s leadership throughout this process has fueled his passion as a life sciences champion and contributed to the success of Vanguard Scientific.
Matthew intends to deliver a global network of integrated systems and solutions to meet the processing needs of the rapidly evolving cannabis and hemp industries. Through partnerships committed to market-leading technology, standards, quality control, and training excellence, Vanguard Scientific Systems will lead with compliance and consistency to provide a stable supply chain to the global marketplace.
Anderson received his degrees in International Business and Economics from Rollins College with an area focus in Performance Ensemble.
Matt is a familiar face in the media and on stages around the world, where he's regularly tapped for insights on the fast-changing cannabis landscape. You may have seen him on The Green Rush, New Cannabis Ventures, CFN, The Motley Fool, Forbes, and News24.
The Full Recording of this Webinar is available here