GDP Audits - Live Online Training How to Audit Logistics Service Providers

GDP Audits - Live Online Training

Course No 21252

All times mentioned are CEST.

Costs

ECA-Member*: EUR 990,--
Regular Fee*: EUR 1190,--
EU/GMP Inspectorates*: EUR 595,--
APIC Member Discount*: EUR 1090,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

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

Speakers

Dr Zvonimir Majic, IATA Senior consultant for Healthcare, Croatia

Objectives

In this Live Online Training you will learn
  • How to conduct GDP audits of road transport vendors, forwarders on airfreight service and forwarders on ocean freight service
  • How to host and prepare for a Quality and Risk Management System and GDP audit
As a participant you will exclusively receive an audit checklist for air, road and ocean transport as well as a compilation of regulatory requirements for the transport of time and temperature sensitive pharmaceutical products. You will further receive two short self-study scenarios with some questions. Answers will be provided during the training.

Background

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.

Target Group

This Live Online Training has been developed for logistics service providers and pharma manufacturers. It is directed at everybody involved in GDP audits.

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.

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

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