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
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