GMP meets GDP

GMP meets GDP

Prague, Czech Republic

Course No 9235


Costs

This conference already took place.

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

Speakers

Kane Edgeworth, Biomap
Dr Afshin Hosseiny, Tabriz Consulting
Dr Andreas König, Aenova Holding
Kai-Uwe Riedel, Swedish Medical Products Agency
Emil Schwan, Swedish Medical Products Agency

Objectives

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.

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 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

Programme

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)?

The Roadmap to Success
Background and comments
Delineation of responsibilities
Introduction to the checklist

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

Best practices in Storage
(how to implement requirements and stay efficient)
Defining your specification
15-25°C and 1-8°C storage

Temperature Mapping
Warehouse, vehicle & cold storage case studies
Protocol preparation
Seasonal variations
Impact tests
Results and reporting

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

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

Security in the Supply Chain
Anti-counterfeiting strategies
What the agencies can do
What industry can do
Compliance issues

Track and Trace and anti-counterfeiting Devices
What is track and trace?
Current technologies and best practices
Anti-counterfeiting devices and management

Workshop Session:

1. 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)

2. Contracts in the Supply Chain
GxP contents of Contracts
How to transfer contents in actions

You can choose one of these 2 workshops offered. Please give your choice when you register for this course.

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