Product Details
FDA and International Cannabis Regulation: What You Need to Know About Products Containing Cannabis
With recent federal government positions on ending the cannabis prohibition nationwide, what do HR and labor law policies look like in the new cannabis era?
What is FDA’s position on cannabidiol (CBD) and other cannabis-derived products?
What are the takeaways from the challenges of regulating plant-based products… dosage challenges… common quality failures and threats?
Interest in cannabis and cannabis-derived compounds such as CBD is exploding, to put it mildly. But for as many products as there are out there, there are almost as many unanswered questions about the science, safety and quality of items containing these compounds.
The FDA and other countries’ regulatory bodies are working through these questions. What exactly must you know to ensure your products are compliant?
Ginette Collazo Ph.D., founder and CEO of Human Error Solutions, is an industrial-organizational psychologist who has written multiple articles for Cannabis Industry Journal. She will cut through the regulatory confusions and explain what you must do to remain compliant and ultimately deliver successful cannabis-containing products.
Presentation Takeaways:
- The impact of current news and events related to cannabis regulations
- How the FDA is regulating cannabis, including how GMPs apply to the medical cannabis industry
- How to comply specifically with the FDA’s regulation of cannabis and cannabis-derived products
- How Canada and Europe are regulating cannabis, including how to comply with comparable GMP regulations from different jurisdictions
- How pharmaceutical manufacturers are determining whether to enter into cannabis production and how GMP 211 would affect that process
- Best practices for dealing with personnel requirements, process controls, procedures development, quality controls and analytical testing in cannabis production
When you understand the cannabis regulatory landscape, you’ll ensure success with products containing cannabis or cannabis-derived compounds. You can’t afford to miss this.
Meet Your Presenter
Ginette Collazo, Ph. D. is an industrial-organizational psychologist who has written multiple articles published in Cannabis Industry Journal. She has 20 years’ experience emphasizing engineering psychology and human reliability, disciplines that study the interaction between human behavior and productivity. Dr. Collazo has held positions leading training and human reliability programs in the pharmaceutical and medical device manufacturing industries. Nine years ago, she established Human Error Solutions (HES), a Florida-based boutique consulting firm, where she has positioned herself as one of the few human error reduction experts in the world. Led by Dr. Collazo, HES developed a unique methodology for human error investigations, cause determination and CAPA development and effectiveness that has been implemented and proven among different industries globally. This scientific method has been applied in critical quality situations and workplace accidents. She is also the author of the book Human Error: Root Cause Determination Model and is a speaker at significant events including Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, Pharmaceutical Industry Association and GMP International Conference.
Who Will Benefit
- Regulatory Specialists
- Quality Specialists
- Compliance Specialists