The cultivation and processing of cannabis for medicinal purposes and as part of the national pilot trials in Switzerland mandatorily require corresponding licenses from the licensing and supervisory authorities. However, many producers who want to enter this market underestimate the hurdles that these requirements can present.
In order to provide clarity here and to manage the balancing act between "What is too little and is criticized by the authorities?" and "What is too much and wastes resources unnecessarily?" gempex has decided to offer its know-how in this area, built up in numerous reference projects, in the form of German language online seminars.
Addressed are all those involved in the cultivation, processing, extraction, isolation, packaging, dispensing and/or import and export of cannabis products in Switzerland.
The online seminar series conveyes everything you need to know about the topic.
It first provides an in-depth insight into the legal requirements and relevant regulations for cultivation and processing, highlights the minimum requirements for GACP/GMP/GDP-compliant quality management systems and shows pragmatic ways to implement them. The important GMP topics of qualification and validation are then covered in greater depth in separate seminars, as are, for example, the ideal procedure for establishing a new production facility or GDP-compliant logistics (including import and export).
The seminars are conducted by gempex GMP experts with many years of specific experience and great consulting competence. They build on each other thematically, but can be booked individually. They are repeated at regular intervals.
The seminar series will start in June 2023.
A total of 8 individual seminars are offered:
1. Licenses and Certifications for GACP, GMP and GDP
What are the legal ways for the handling of cannabis? What is regulated, what is not? What does this mean for my QMS? What costs do I have to expect?
2. Basic Knowledge of GACP
What is GACP and what role does it play in the medical use of cannabis and for pilot trials? Which legal/regulatory requirements have to be considered? Which contents have to be implemented?
3. Basic Knowledge of GMP
What is the difference between GACP and ISO9001? What do authorities require? What are the essential contents?
4. GACP-QMS
What are the minimum requirements to be implemented in a GACP-compliant QMS? What can such a QMS look like? Opportunities of an integrated GACP QMS together with ISO9001 and GMP.
5. GMP QMS
What should a GMP-compliant QMS look like? What has to be considered during the concept? Opportunities of an integrated GMP QMS together with ISO9001 and GACP.
6. Qualification and Validation
What does it mean and what is it needed for? What has to be concidered? How can you proceed pragmatically and in accordance with the regulations?
7. GDP, Wholesale, Import and Export
What is GDP and what has to be concidered? Which legal requirements are there for import and export, which for wholesale? What should a GDP-compliant QMS look like?
8. The Way to Success
Realize projects pragmatically with the gempex method.
Info and registration on gempex.ch/cannabis-online-seminare
For questions to the topic Dr. Ralf Prescher, Senior Consultant of gempex GmbH, is available via contact@gempex.com.
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