Dr. Sue Mann
Sue Mann Consultancy
Referent:innen
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
Kane Edgeworth
Biomap
Emil Schwan
Swedish Medical Products Agency
Zielsetzung
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.
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.
Hintergrund
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.
Zielgruppe
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Programme (Day 1 + Day 2)
Welcome and Introduction
European Regulatory Requirements and Guidance
Welcome and Introduction
European Regulatory Requirements and Guidance
- What are the rules and regulations?
- 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
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
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.
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
| GDP Association Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online 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
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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