GMP meets GDP

GMP meets GDP

Berlin, Germany

Course No 15750


Costs

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

(All prices excl. VAT)

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


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
Supply Chain Security (1):
  • Expectations of the Inspectorates
  • Anti-counterfeiting strategies
  • What the agencies can do
  • What industry can do
  • Compliance issues
Supply Chain Security (2):
  • How to minimise Risks
  • FMD requirements and the link to GDP
  • Timelines for industry
  • What the distributors an 3LPs need to know
  • What else companies need to do to prevent security risks
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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