Live Online Conference: GMP for Cannabis – GACP-Post-Conference

Live Online Conference: GMP for Cannabis – GACP-Post-Conference

Course No 18326

Note: All times mentioned are CET.

There will be no recording of this Live Online Conference.

Costs

ECA-Member: EUR 590,--
Non ECA Member: EUR 690,--
EU/GMP Inspectorates: EUR 345,--
APIC Member Discount: EUR 640,--

(All prices excl. VAT)

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

Speakers

Dr Joachim Erler, Auditor / QP, Blue Inspection Body, Germany
Luis Meirinhos Soares, GMP / GACP Inspector, Infarmed, Portugal, Member of the ECA Cannabis Working Group
Angela Müller, Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, Germany

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because
of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

13.30 – 13.45 h Welcome and Introduction

13.45 – 14.45 h
The Intersection between GACP and GMP - View on the Inspection of Cannabis GACP and its Relation to GMP
  • When does GACP end and (EU) GMP start?
  • What will be checked during GACP and EU GMP inspections?
  • Observations in inspections
  • Open questions and issues to be solved
14.45 – 15.00 h Time for Discussion
 
15.00 – 15.15 h Coffee Break
 
15.15 – 16.00 h
GACP – Regulatory Information
  • ƒHerbal Drugs
  • ƒFramework
  • ƒGACP vs. GMP
    • Guidelines
    • Interpretation
  • ƒInformation in the Dossier
    • Mockup
    • Grower and Supplier
    • Geographical source
    • Herbal substance Manufacturing
16.00 – 16.30 h
GACP – Auditor´s View
  • Cannabis Cultivation
  • SOPs & records
  • Expectations of a GACP auditor
16.30 – 16.45 h Time for additional Questions and Discussion
 
16.45 – 17.00 h Break
 
17.00 – 17.30 h
GACP – Grower´s / Supplier´s View
 
17.30 – 18.00 h Final Discussion

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