Post-Conference: Qualification & Validation Aspects for Cannabis - Live Online Conference for Growing, Processing, Handling and Storage of Medical Cannabis

Post-Conference: Qualification & Validation Aspects for Cannabis - Live Online Conference

Course No 19593

Note: All times mentioned are CET.
 
For participants only
- Every participant will receive the printed version of ECA´s Cannabis Roadmap - Global GMP Requirements and Regulatory Information on Medicinal Cannabis (and CBD Products)!
- Non-official English translations of the German Pharmacopoeia (DAB) Monographs Cannabis flower and Cannabis Extract for download

Costs

ECA-Member*: EUR 990,--
Regular Fee*: EUR 1090,--
EU/GMP Inspectorates*: EUR 545,--
APIC Member Discount*: EUR 1040,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Mike Kleinebecker, Siemens, Germany
Dr Ingrid Walther, Pharma Consulting Walther, Germany, Leader of the ECA Cannabis Working Group
Sebastian Zeller, Canexis Pharma, Switzerland

Objectives

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.

Background

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.

Target Group

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.

Technical Requirements

We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

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
Final Discussion

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