GMP meets GDP
(Im Auftrag der European Compliance Academy)

8-9 November 2016

Barcelona, Spain

Seminar Nr. 15359

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

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)?

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: 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)

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GMP meets GDP(Im Auftrag der European Compliance Academy)