GMP’s Applied to Medical Cannabis: All You Need to Know
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.
Ginette Collazo, Ph. D. 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.
When we discuss growing, producing, and manufacturing medical cannabis, we must think of it as a medicine. Medicine by definition 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.
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. 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.
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 the 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 in GMP compliance
Areas Covered
- Current events associated with 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
Course Level - Intermediate
Who Should Attend
- Training Managers and Coordinators
- Operations
- Manufacturing
- Plant Engineering
- QA/QC Staff
- Process Excellence/Improvement Professionals
- Industrial/Process Engineers
- Compliance Officers
- Regulatory/Legislative Affairs Professionals
- General/Corporate Counsel
Why Should You Attend
Attend the webinar to learn what the regulations say about medical cannabis, including GMP guidelines for pharmaceuticals, cannabis quality control regulations, and more.
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