GMPs for Cannabis Operations
When : Friday, November 19, 2021
Time : 01 : 00 PM EST
Duration : 60 Minutes
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a
regulatory, Lean Manufacturing, training, and technical documentation
consulting firm. Charles is a management consultant, instructional
designer, and regulatory consultant and has led C. H. Paul Consulting,
Inc. since its inception over 25 years ago. He regularly consults with
Fortune 500 pharmaceutical, medical device, and biotechnology firms
assisting them in achieving human resource, regulatory, and operational
excellence. He is a regular presenter of webinars and on-site seminars
in a variety of related subjects from documentation development to
establishing compliant preventive maintenance systems. The firm works
globally completing projects throughout the EU, UK, South America, and
Asia.
This webinar will provide a basic foundation for Good Manufacturing Practices essentially for any medical marijuana production operation. Medical marijuana growing and production is a regulated industry and is becoming more regulated every day. GMPs pertain to medical marijuana just as they do to pharmaceutical, medical device biologics, foods, etc. Unfortunately, there is no unified standard as to how they apply. This webinar will set the stage for a level of GMP application to this industry.
The medical marijuana industry is in its infancy in the United States. A large number of individual states have legalized medical marijuana to varying levels of control and regulation. Medical marijuana is illegal on a US Federal level but all predictions are that this situation will change…exactly when is not clear….but it is difficult if not impossible to “put the genie back into the bottle.” Pharmaceutical products, foods, beverages, medical devices, nutritional, etc are all regulated in the US to some level and degree by the FDA under the Food Drug & Cosmetic Act.
GMP refers to the Good Manufacturing Practice Regulations established by the US Food and Drug Administration under the act which have the force of law. Those GMPs require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood products take proactive steps to ensure that their products are safe, pure, and effective. Since medical marijuana is not a legally recognized and regulated medicinal product in the US, we can only review GMPs as they relate to the wide range of international and US individual state cannabis regulations along with existing non-cannabis GMPs to determine how to best operate our cannabis operations.
Areas Covered
- Overview of GMPs – Why are GMPs important?
- Regulatory history
- Forms of medical marijuana
- General Requirements – Acquisition of cannabis
- Operational Plans and Procedures
- Personnel
- Documentation and training
- Facilities – Grower/Processor
- Plants versus Seeds
- Visitor Access
- Security and surveillance
- Growing and processing requirements
- Inventory
- Storage
- Equipment Operation & Maintenance
- Sanitation and safety
- Packaging and labeling
- Transportation and tracking
- Disposal of medical marijuana waste
- Complaints & recall handling
- Pesticides and pest handling
Course Level - Basic/Intermediate
Who Should Attend
GMPs apply to everyone in the organization. They represent the basic knowledge that everyone must possess and the requirements that must be practiced for the organization to be fully compliant. All levels and functions within the Cannabis production operation would benefit from this basic GMP training.
Why Should You Attend
It
is critical as cannabis production takes its place in the mainstream of
US medicinal production, that all companies currently operating under
individual state auspices understand and align their operations with
existing GMPs to be in compliance when cannabis is federally recognized.
This webinar will provide the foundation for the understanding of GMPs
in pharmaceuticals in terms of cannabis growing and production.
