GDP for Beginners
Im Auftrag der ECA Academy

GDP for Beginners Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17909


Kosten

ECA-Member: EUR 1490,--
Non ECA Member: EUR 1690,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--
GDP Association Member Discount: EUR 1490,--

Alle Preise zzgl. MwSt.

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

Sprecher

Kane Edgeworth, Biomap, U.K.
Dr Zvonimir Majic, Teva Pharmaceutical Industries Ltd., Croatia
Sue Mann, Sue Mann Consultancy
Emil Schwan, Medical Products Agency, Sweden

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.

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.

Roadmap to Good Distribution Practice

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

Programm

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)?
The Roadmap to Success
  • Background and comments
  • Delineation of responsibilities
  • Introduction to the checklist
Best practices in Storage (how to implement requirements and stay efficient)
  • Defining your specification
  • How to set up an adequate storage facility
  • 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
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)
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
Supply Chain Security
  • Anti-counterfeiting strategies
  • What the agencies can do
  • What industry can do
  • Compliance issues
Import and Export under new Circumstances
  • New and possible future regulations impacting import and export (e.g. Annex 21, MRA)
  • Political developments impacting import and export (e.g. Brexit, trade Embargos)

Zurück

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