All participants will exclusively receive an audit checklist for air, road, and ocean Transport.
Target Group
Logistics service providers
Pharmaceutical manufacturers
Quality assurance and compliance managers
Responsible Persons (RP)
GDP auditors
Anyone involved in GDP audits and supply chain compliance
Objectives
The EU GDP Guidelines highlight the need for appropriate controls for all partners and service providers in the distribution chain (like road transport vendors, forwarders on airfreight service and ocean freight service). Qualification of these partners, for example through audits, is a core element in implementing the GDP requirements.
In this Live Online Training you will learn
How to conduct GDP audits of road transport vendors, air freight forwarders and ocean freight forwarders
How to prepare for and successfully host a Quality and Risk Management System and GDP audit
How to identify compliance gaps and risk areas in pharmaceutical transport
As a participant, you will exclusively receive:
A comprehensive audit checklist for air, road and ocean transport
A compilation of regulatory requirements for time- and temperature-sensitive pharmaceutical products
Practical self-study scenarios including guided discussion and answers
Programme
Module 1: Auditing Forwarders, Logistics Service Providers and Transport Companies
Part 1: Audit methodology for different transport modes (on site, paper audit, virtual audit considerations)
Part 2: Audit of road transport vendors
Part 3: Audit of forwarders on airfreight service
Part 4: Audit of forwarders on ocean freight service
Module 2: Hosting and Preparation for a Quality and Risk Management System and GDP Audit
Part 1: Compliance requirements for road transport vendors
Part 2: Requirements for forwarders offering airfreight service
Part 3: Requirements for forwarders offering ocean freight service
Feedback Summary for Self-Study Scenarios & Q&A Sessions
Further Information
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.
Fees (per delegate, plus VAT) ECA Members EUR 1,190.- GDP Association Members EUR 1,190.- APIC Members EUR 1,240.- Non-ECA Members EUR 1,290.- 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.
Conference language The official conference language will be English.
Testimonials
