Dr Marcel Günther
Regierungspräsidium Tübingen
Referierende
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 Online Training Course 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
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Recording from 22 October 2026
Duration of the recording: 5h 3m
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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