Medical Cannabis 2020 Updates – FDA and International GMP Guidelines

When we discuss growing, producing, and manufacturing medical cannabis, we must think of it as a medicine. Medicine by definition, it is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and quality controls in medical cannabis production, there is still a lot to learn.

The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket. In order to start understanding what it means for GMP regulated industries, we will discuss what we need to know, for now.

Why You Should Attend:

With all new events the FDA has stated that it “recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD.” However, there are many unanswered questions about the science, safety, and quality of products containing CBD. Attend the webinar to learn what the regulations say about medical cannabis, including GMP guidelines for pharmaceuticals, cannabis quality control regulations and more.

Learning Objectives:

  • Recent federal government position on ending Cannabis prohibition nationwide
  • FDA position on CBD and other cannabis derived products Background from a regulatory standpoint.
  • Approvals by states and what have we learned.
  • Challenges with regulation of plant-based product
  • Dosage challenges
  • HR policies and the new cannabis era (labor laws challenges)
  • Common quality failures and threats
  • Prepare for what’s next.

Areas Covered in the Session :

  • Current events associated to cannabis
  • FDA, CANADA, and Europe regulations and standards
  • What does it mean for drug manufacturing sites?
  • Application from Pharma to Cannabis
  • Our role from GMP standpoint.
  • Industry crossover

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Compliance Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Training Departments
  • Process Excellence / Improvement Professionals
  • Plant Engineers
  • Industrial / Process Engineers
  • General / Corporate Counsel

FDB3212

Dr. Ginette Collazo

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

She is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

membership


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance