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PHARMACEUTICAL CANNABIS COMPLIANCE CONGRESS

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Experience hands on compliance modeling lead by key influencers, internationally accredited organizations, and federal regulators

April 20 - April 21

San Diego, United States

The cannabis industry is rapidly growing and will exceed 25 billion in North America alone. The wave has clearly turned in legalization of marijuana for medical use and legal recreational use on the rise. FDA is aware that patients, caregivers and the pharmaceutical industry alike want alternatives to unmet medical needs and supports sound scientific research. Now is the time for the cannabis and pharmaceutical industries to converge to map a path forward in best practices in research and development and GMP compliance. KENX is proud to present Pharmaceutical Cannabis Compliance Congress on April 20-21, 2020 in San Diego, CA. Whether you are in the Life Science or Cannabis in Science, R&D or Compliance this is a must attend to event to drive this important environment and movement forward.

 

  • Examine FDA position, ASTM D37, AHPA, USP & AOAC and other important guidance
  • Stay ahead of the regulatory curve by examining regulations, certification and trends by state
  • Pave the way for GMP compliance with best-in-class validation processes
  • Key insights on cannabis data analysis and testing
  • Understand the bioavailability of medical cannabis
  • Set analytical test methods established by cannabis working groups
  • Overcome challenges in cannabis cleaning validation and critical cleaning processes
  • Examine sample preparation technology for cannabinoid residue extraction
  • Understand the impact of cannabinoid replacement therapies
  • Develop best practices to formulate and evaluate cannabis drug delivery
  • Cultivating, harvesting and extraction – Keeping cannabis safe
  • Discover formulations of cannabis-derived compounds
  • The role of cannabinoids and skin diseases

 

Who Should Attend:

Life Science and Cannabis Industries

  • QA/QC
  • Analytical Lab Management
  • Scientists/Chemists
  • Research & Development
  • Drug Delivery
  • Validation and Compliance
  • Cannabis cultivators and research

Agenda

More Information To Follow Soon

Faculty

  • Sherri Tutkus BSN-RN, founder and CEO of GreenNurse Group, Medical Director at Irie Bliss Wellness

    Sherri is a cannabis nurse, patient and advocate. She earned her Bachelors in Science and Nursing from Boston College. She is highly skilled Registered Nurse with 30 years’ practical experience in various departments within the hospital and home setting. She is utilizing her expert nursing skills as a medical center specialist, clinical nurse liaison and educator to bridge the gap between patients and the cannabis community. Sherri has been educating and implementing holistic integrative healing modalities within her practice for over 20 years. She educates on the endocannabinoid system and the safe utilization of cannabis at dispensaries, hospitals, clinics, patients homes and she regularly does pop up events, seminars and expos. Sherri has written a chapter in the first cannabis nursing textbook for nursing students with her cannabis nurse colleagues. Sherri is a member of the American Cannabis Nurses Association and the Cannabis Nurses Network and she brings passion and purpose to her work teaching bio-psycho-social-spiritual healing using cannabis as a tool.
  • Christina DiArcangelo, CEO and Founder, Affinity Bio Partners; CEO and Board President, Affinity Patient Advocacy; CEO and Co-Founder, AI Health Outcomes, CannaBot™

    Christina DiArcangelo, CEO and Founder of Affinity Bio Partners, CEO, Board President of Affinity Patient Advocacy and CEO and Co-Founder of AI Health Outcomes, CannaBot™, has forged a world-class reputation in the Biotechnology and Pharmaceutical industry for the past 20 years. Her engagements have led to numerous industry awards, keynote speaking engagements, multitude of global clinical trials as well as working on several drugs that have received FDA approval and the ultimate respect of her industry peers. Throughout the course of Christina's career, she has acted in various capacities for Global Clinical Research Organizations, Pharmaceutical Companies and Biotechnology Companies.
  • Dr. James E. Sulton, Jr., President and CEO, The Sulton Center

    Dr. James E. Sulton, Jr. currently serves as the President and CEO of The Sulton Center, a multidisciplinary research and consulting firm based in Orangeburg, S.C. The Center has been in existence since 2007 providing a wide range of support for individuals, institutions of higher learning and small businesses. The Center helps entrepreneurs and professionals navigate governmental regulatory environments. As an experienced professional with a diverse background Dr. Sulton helps enable small business and start-up owners to succeed.
  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim Huynh-Ba has over 25 years of experience in quality systems, project management, strategic drug development and stability sciences. She currently is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT). She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. Kim has authored numerous technical publications, book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She is also working on a manuscript for the textbook “Analytical Chemistry: An Introduction to Pharmaceutical GMP Laboratory,” that is expected to be available in 2019. Kim can be reached at kim.huynhba@pharmalytik.com.
  • Beth Kroeger, Technical Services Manager, STERIS Life Sciences

    Beth Kroeger is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and the National Institute for Bioprocessing Research and Training. Beth has over 25 year’s industry experience in R&D involving infectious diseases and Biopharmaceutical and Oral Solid Dose manufacturing operations. Prior to her current position, Beth was employed by Janssen Biologics and Biotest Pharmaceuticals where her areas of expertise included large scale fermentation systems, both continuous perfusion and fed batch, and downstream operations including large scale purification processing, viral removal, UF and final fill.
  • David W. Vincent, CEO, MPH, PhD for VTI Life Science

    David Vincent has over thirty-two (32) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, B.Sc., Mechanical Engineering Technology, Master and PhD in Public Health. He has hands on experience in many areas of Regulatory Affairs, Quality Assurance and Commission/Qualification, Engineering including; regulatory submission preparation, Design Review, Microbiology Laboratory setup and qualification, Construction Qualification, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Process Development and Validation, Cleanroom design and management as well as developing and implementing Aseptic and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries but also support medical devices, biotechnology and pharmaceutical industries
  • Jacquie Cohen Roth, Founder/CEO, CannabizMD and Tea Pad

    Jacquie Cohen Roth is Founder/CEO of CannabizMD and Tea Pad. She’s driven by her commitment to health and wellness with a vision for strategic opportunity in the medical cannabis industry combining innovation, quality patient care and social justice with economic opportunity. She’s a national and international speaker on the medical cannabis industry. Jacquie is a member of the nation’s first cohort in an MSc in Medical Cannabis Science and Therapeutics at the University of Maryland School of Pharmacy.
  • Dr. Willis H. Thomas, PhD, PMP, CPT, PQE Group

    Willis H. Thomas, PhD, PMP, CPT has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations. He has 17 years of experience in the pharmaceutical industry. Dr. Thomas is adjunct faculty at the Lake Forest Graduate School of Management, International Institute for Learning and Institute of Validation Technology.
  • Noah Persin, CEO, GreenSea Group

    Noah has been involved in the professional cannabis and hemp industries for over 30 years. During this time, he has owned and/or currently owns and manages cannabis farms, cannabis processing facilities, a cannabis/hemp trade group, a cannabis/hemp distribution company, data collection companies in the cannabis/hemp sectors, an environmental control manufacturing company for indoor and greenhouse cannabis production, electrical and general building contractors, and an import/export company with offices in central and southeast Asia and Oregon. He also started and heads an international think tank.
  • Mark Smolenski, M.D., P.H.P., Chief Operations Officer, BioScision

    Mr. Smolenski is a business leader in the health care industry with over 30 years of experience in both the private and public sectors. He has worked in start-up, growth and Fortune 500 companies at many levels. Starting at the lab bench and progressing into strategic operations roles at the executive level Mr. Smolenski has a proven record of success. Mark has held senior leadership positions in Operations and Product Development with BioScision Pharma, Cangene Corporation, Abbott Laboratories and Biomira.
  • Pedro Jorge, Head of Regulatory Affairs, Head of QA, BioScision

    Mr. Jorge is a leader in the life science industry with over 30 years of experience in quality control / quality assurance and product development. He is a leader with a proven track record in the development, global commercialization and control of healthcare products. Mr. Jorge has an undergraduate degree in Science (BSc.) and a Biochemistry Technology diploma.

Sponsors


  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/

  • Global Leader in Paperless Validation.
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

    More Information To Follow Soon

Venue

Details

Start:
April 20
End:
April 21
Event Category:

Venue

Hilton Mission Valley
901 Camino del Rio S
San Diego, CA 92108 United States
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Pricing & Registration

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