Dr. Marcel Günther
Regierungspräsidium Tübingen
Referent:innen
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Martin Melzer
Gempex
Zielgruppe
- API manufacturers
- API distributors and traders
- Pharmaceutical manufacturers
- Wholesalers
- Transport service providers
- External warehouses
- further service providers offering services for the distribution of APIs
Zielsetzung
Good Distribution Practice (GDP) is the part of quality assurance that ensures their quality is preserved throughout every stage of the supply chain. Consequently, all partners involved in distribution must comply with GDP principles.
However, GDP is not limited to medicinal products. It begins earlier – namely with the transport of active pharmaceutical ingredients (APIs) used for manufacturing. A number of guidelines and supplementary documents provide requirements on the distribution of active substances, which must be implemented accordingly.
This Live Online Training offers a comprehensive overview of the current GDP requirements for active substances for human and veterinary medicinal products. It also highlights how these regulatory expectations can be effectively translated into practice from different professional perspectives.
Programm
Regulatory Requirements related to GDP for Active Substances
- Regulations and guidelines
- Existing requirements
- Regulatory oversight of GDP in practice
GDP-Compliant Transport of Active Substances (Human and Veterinary)
- Practical implementation of requirements
- Requirements for temperature monitoring and vehicles
- Use of transport service providers
- Requirements for traceability
GDP-Compliant Storage of Active Substances (Human and Veterinary)
- Practical implementation of requirements
- Requirements for temperature monitoring
- Requirements for inventory/ERP systems
- Requirements for quality risk management
Regulatory Inspections and Typical Inspection Findings
- Procedure of regulatory inspections
- Scope, focus areas and inspection reports
- Classification and handling of deficiencies
- Frequent and typical deficiencies in warehousing, logistics and transport
Monitoring of Suppliers and the Supply Chain from the Perspective of the Qualified Person
- Requirements for supplier qualification
- Global supply chains
- Importation
- Certification
- Supply chain documentation
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At 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.
We use Webex for our live online training courses and webinars. At 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.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 1,290.-
ECA Members EUR 1,090.-
APIC Members EUR 1,190.-
EU GMP Inspectorates EUR 645.-
The fee is payable in advance after receipt of invoice.
Non-ECA Members EUR 1,290.-
ECA Members EUR 1,090.-
APIC Members EUR 1,190.-
EU GMP Inspectorates EUR 645.-
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Thu., 22 October 2026, 09.00 - 17.00 h
All times mentioned are CEST.
All times mentioned are CEST.
Teilnahmegebühr
| Reguläre Teilnahmegebühr*: | € 1290,- |
| ECA-Member Rabatt*: | € 1090,- |
| Teilnahmegebühr für Mitarbeiter/innen von GMP-Überwachungsbehörden*: | € 645,- |
| APIC Member Rabatt*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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