During day 1 and day 2 of this course, well experienced speakers will share their expert knowledge about all relevant aspects regarding the current GMP and GDP requirements and current developments in storage, transportation and Cold Chain Management of medicinal products. You will learn how these requirements evolve and how they can be implemented efficiently.
On Day 3, participants will benefit from a guided tour of the DHL Campus and Vienna Airport, providing exclusive insights into the operations and specialized handling of Life Sciences and Healthcare shipments.
For participants of the airport tour:
For security verification your personal data (including name, address, company, date of birth, and email address) will be transmitted to DHL Group and Vienna Airport.
A valid ID document is required for the security check prior to the airport tour, and a copy must be submitted in advance.
After registration, we will contact you with further Information.
Background
Globalisation, counterfeiting problems and the expectations regarding pharmaceutical storage, transport and cold chain management are forcing the pharmaceutical industry to challenge their current practices. Companies have to increase their effort and validation activities as one prerequisite for safe and secure storage and transportation of their medical products over boarders and through various climatic conditions. Directives, Guides, Guidelines and initiatives from various regulatory bodies lead the way in this development and define expectations and requirements, where Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are closely linked.
Target Group
This education course is designed for all managers, supervisors and other staff members who are involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Who is responsible for maintaining product quality in the supply chain
Cold Chain and ambient storage and transportation
The revised EU Guidelines on Good Distribution Practice (GDP)
Who needs a Responsible Person (RP)?
Introduction to the Roadmap to Success
Background and comments
Delineation of responsibilities
Introduction to the checklist
Case Study on Temperature Mapping Warehouse, Vehicle & Cold Storage Case Studies
Protocol preparation
Seasonal variations
Impact tests
Results and reporting
Understand your Supply Chain
Selection of the supply route
Process mapping of a supply chain
Developing a QMS for supply chain (Policies, SOPs, documentation & Training)
Best Practices in Storage
Defining your specification
How to set up an adequate storage facility
15-25 °C and 2-8 °C storage
GDP Role Play (acted out by the Speakers)
During this session, there will be Q&A role play between an auditor and an auditee acted out by the speakers. After each question answered, a short reflection will be provided by an inspector on regulatory standpoint.
Cold Chain Management and its Validation
Validation of transport and hold time
Validation vs. monitoring
Qualification of various transport routes
Data collection and evaluation
Best Practices in Transport and Logistics
How to implement the requirements and stay efficient
Managing 15-25 °C and 2-8 °C transportation
Challenges that different modes of transportation introduce to pharmaceuticals
Supply Chain Security
Anti-counterfeiting strategies
What the agencies can do
What industry can do
Compliance issues
Shipping Stability
What should industry do and deliver
Using stability data to assist in supply chain design
What is the necessary data to discuss excursions
Discussion of possible deviations and excursions
Deviation Handling: Pharma Shipment without a Data Logger
How to support product release in case of missing data loggers in road, air or ocean shipments
Data accessibility and validity
Record types and supporting documents
Investigation report and CAPA
Import and Export under new Circumstances
Regulations impacting import and export (e.g. Annex 21, MRA)
Political developments impacting import and export (e.g. Brexit, trade embargos)
Programme (Day 3)
Airport Tour in co-operation with DHL on Day 3
Guided tour of the DHL Campus and Vienna Airport, providing insights into operations and facilities.
Exclusive access to an international logistics hub, offering a behind-the-scenes look at the specialized handling of Life Sciences and Healthcare shipments.
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials
Seminar Programme as PDF