Dr.Sue Mann
Sue Mann Consultancy
Referent:innen
Dr Zvonimir Majic
PLIVA Hrvatska
Kane Edgeworth
Biomap
Emil Schwan
Swedish Medical Products Agency
All times mentioned are CET.
Zielsetzung
During 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.
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.
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
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
Roadmap to Good Distribution Practice
All participants receive a Roadmap to Good Distribution Practice containing:
All participants receive a Roadmap to Good Distribution Practice containing:
- An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
- A checklist for the implementation of GDP principles
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)
Q&A sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
| GDP Association Member Discount*: | € 1690,- |
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
Aufzeichnung nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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