Your Gateway to the New Cannabis Era
Cannabis GXP is excited to offer specialized courses
Cannabis GXP is excited to offer specialized courses in the international Cannabis industry.
Participants will be introduced to an advanced scientific and technological framework for understanding the industry, a wide variety of product knowledge and the regulations comprehension required to operate successfully within a global market.
As a consultancy firm, Cannabis GXP, our work and expertise is based on knowledge and experience acquired both from the theory and from the field. We believe that the new era of the global Cannabis market is distinguished from the past one in terms of scientific information, knowledge, proven data and regulations.
We would be happy to share with you the vast experience we have been accumulating over the years.
You will find below the courses we offer, relevant to many diverse fields according to your needs: Cannabis cultivation, manufacturing, R&D, GXP and regulations.
Cannabis flowers and other cannabis products used for medical and recreational purposes should meet regulatory requirements for safety, quality, and uniformity. In order to meet quality and safety specification for the final product, cannabis growing facility and cultivation techniques should be standardized, controlled and optimized for both outdoor or indoor facilities.
The GACP international standard implementation will enable proper cannabis crop growth and conditions towards final dried flowers with the best quality and cannabinoids content uniformity.
This course will help the participants to familiar themselves with the cannabis cultivation and post harvest processes and the existing and new techniques available and to understand how the different standards are critical to the proper management of a regulated growing facility.
More specifically this course will cover GACP standard and regulatory requirements and review its interpretation and implementation in greenhouse, indoor and post-harvest facilities. We will discuss how a proper implementation of Quality & Operation Management System in your growing facility will improve the uniformity, quality and yield of the cannabis plant’s crop. We will also discuss how to implement GMP and GDP principles as part of your trimming, packaging, storage, curing and transportation. We will also approach the relevant quality control testing and analysis in order to release your products in the global market.
- GACP design principles and requirements in cannabis growing facilities
- Risk identification and mitigations
- Control and monitoring in cannabis cultivation stages
- Growing cannabis in greenhouses vs. indoor
- Pest Control and prevention in Cannabis cultivation
- Cannabis crop quality and uniformity
- Procedures and documents required for Cannabis growing facilities
- Employees gowning and day to day GACP working practices
- Preparations towards external regulatory inspection
Cannabis dried flowers used for medicinal and recreational purposes are still being consumed by smoking, eating or vaporizing which are considered as inaccurate, inconsistent and unhealthy and their usage does not conform to the basic requirements and standards expected from a medical product. In addition, these out-of-date delivery systems of cannabis products is not suitable for most of the patient population, and even if it helps the consumer, it may simultaneously harm him and endanger his health.
Doctors who treat patients using cannabis products are accustomed to providing medical treatment using “pharmaceutical grade drugs” that faithfully represent safety, efficacy, quality, accuracy, consistency etc.
Moreover, Cannabinoids and/or other pharmaceutical active ingredients, in order to achieve pharmacological effect, need to be absorbed and reach the target organ properly using a proper dosage form.
In the pharmaceutical industry, there are several accepted pharmacological dosage forms such as solids (tablets, powder, capsules), semi-solids (cream/pastes) and liquids (oils, eye drops etc.). Each delivery system and dosage form have its unique pharmacological characteristics and the scientific principles upon which they are based and have the most appropriate manufacturing technologies and product formulation.
The course will enable participants to familiarize themselves with the existing and new cannabis manufacturing technologies and understand the advantages and disadvantages of each technology and understand the main challenges of moving from development to production.
- Review of pharmacological forms for medicinal cannabis products
- Cannabis manufacturing facilities design based on GMP standards
- Infrastructure and utilities required for cannabis manufacturing facilities
- Clean rooms for cannabis production
- Engineering principles to be implemented in Cannabis manufacturing technologies
- Cannabis Quality Management System and procedures
- Stability tests for cannabis products
- Good Manufacturing Practices (GMP) standards for cannabis-based products
- Validation for cannabis equipment and production systems
- Large scale Cannabis production project management
The risk management approach in the pharmaceutical and medical devices industries is a regulatory requirement which is relevant for new products development, manufacturing as well as for Cannabis growers and manufacturers.
“Risk based approach” is a common term in Bio-Med industry regulations and therefore requires Cannabis growers and manufacturers to identify, analyze, control and manage risks associated with growing cannabis plants as well as the production, storage and supply of cannabis products.
The requirement for risk analysis and risk management is mentioned in various regulatory standards as part of quality systems management such as ISO 13485, ISO 14971_2007 and others.
In this course we will review the relevant terms and definitions of risk management and analysis, and how this field has developed over the years. We will also focus on the importance of identifying and controlling the many risks for cannabis growers, medical cannabis product developers, and cannabis product manufacturers to which our patients and consumers are exposed.
We will discuss which techniques should be used to effectively identify, control and minimize risks in order to grow and manufacture high quality and safer products.
In addition, as part of the course, we will practice the FMEA technique in order to demonstrate and analyze the different Cannabis business related risks.
- Terms and definitions relevant to risks in the cannabis industry
- Regulatory Review
- How the field of risk management developed over the years
- The importance of identifying, managing and controlling risks in the growing cannabis plant
- The importance of identifying, managing and controlling risks in the cannabis drug production
- FMEA risk assessment technique
- FMEA risk assessment practice