Live Online Training: GDP for Beginners Im Auftrag der ECA Academy

Live Online Training: GDP for Beginners Im Auftrag der ECA Academy

Kurs Nr. 18583

Alle weiteren Termine dieses Seminars finden Sie in dieser Übersicht.

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

Speakers

Kane Edgeworth, Biomap
Dr Zvonimir Majic, Teva Pharmaceutical Industries
Sue Mann, Sue Mann Consultancy
Emil Schwan, RegSmart Life Science

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 of medicinal products. 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, cold chain and distribution activities and the control of those activities.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Day 1

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
  • Protocol preparation
  • Seasonal variations
  • Impact tests
  • Results and reporting
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 1-8°C storage
Programme Day 2

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
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
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)
Final Discussion

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