Sprecher
Kane Edgeworth, Biomap
Dr Afshin Hosseiny, Tabriz Consulting
Dr Andreas König, Aenova Holding
Emil Schwan, Swedish Medical Products Agency
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. 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.
Zielgruppe
This education course is designed for all managers, supervisors and other staff members who are involved in pharmaceutical storage, transportation and cold chain and distribution activities and the control of those activities.
Roadmap to Good Distribution Practice
Each participant receives 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
Programm
Regulatory Requirements and Guidance
- What are the rules and regulations?
- Who is responsible for maintaining product quality in the supply chain
- Key challenges and criteria to consider
- Cold Chain and ambient storage and transportation
- The revised EU Guideline on Good Distribution Practice (GDP)
- Who needs a Responsible Person (RP)?
- Background and comments
- Delineation of responsibilities
- Introduction to the checklist
Each participant receives 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
- Defining your specification
- 15-25°C and 1-8°C storage
- Warehouse, vehicle & cold storage case studies
- Protocol preparation
- Seasonal variations
- Impact tests
- Results and reporting
- Validation of transport and hold time
- Validation vs. monitoring
- Qualification of various transport routes
- Data collection and evaluation
- 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
- 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
- Anti-counterfeiting strategies
- What the agencies can do
- What industry can do
- Compliance issues
- What is track and trace?
- Current technologies and best practices
- Anti-counterfeiting devices and management
- Selection of the supply route
- Process mapping of a supply chain
- Developing a QMS for supply chain (Policies, SOPs, documentation & Training)
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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