Mike Kleinebecker, Siemens, Germany
Dr Ingrid Walther, Pharma Consulting Walther, Germany, Leader of the ECA Cannabis Working Group
Sebastian Zeller, Canexis Pharma, Switzerland
More and more countries around the world legalize cannabis for medical use. But what qualifies as medical grade cannabis? And which aspects have to be considered in particular during Qualification/Validation? The dedicated Post-conference will provide you with the necessary details for medical cannabis products.
Qualification and Validation is an essential GMP requirement. Non-EU suppliers, who currently produce according to GPP, will have to implement EU-GMP standards if they want to supply herbal drugs like medical cannabis to the EU market. But which requirements apply? And what does it mean in practice? The post-conference will specifically answer these questions and provide you with practical examples.
The Post-conference specifically addresses Qualification/Validation aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, Wholesalers, QPs and QA/QC personnel involved in Cannabis production.
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Environmental Control and Monitoring
- Solutions to control and monitor facilities in a safe, efficient and GMP-compliant manner
Process Validation & Equipment Qualification
- Qualification of equipment / rooms / facilities / utilities (Systems)
- Qualification / Validation Master Plan (VMP)
- Principles of Quality Risk Management (QRM)
- How to identify critical parameters
Case study: A New Production Facility for Cannabis
The presentation will provide insight in:
- The main concept to set-up a Cannabis production facility
- The zone concept, general layouts, hygienic aspects
- How to integrate GMP requirements in the Project
- How to deal with the authority
- How to qualify suppliers
- Realization of Qualification and Validation in practice
Experiences / Lessons learned
- Changing Rooms – Air-locks - Zoning Concepts
- Room Design and Room Separation
- Drying Process – What needs to be done?
- Points to consider