Good Distribution Practice of Active Substances for Human and Veterinary Medicinal Products
Course No. 23321
Speakers
Dr Marcel Günther
Regierungspräsidium Tübingen
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Martin Melzer
Gempex
Target Group
API manufacturers
API distributors and traders
Pharmaceutical manufacturers
Wholesalers
Transport service providers
External warehouses
further service providers offering services for the distribution of APIs
Objectives
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.
Programme
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
Further Information
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.
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.
Conference language The official conference language will be English.
Testimonials
