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 Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
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
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
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 2-8 °C storage
GDP Role Play (acted out by the Speakers)
During this session, there will be Q&A role play between an auditor and an auditee acted out by the speakers. After each question answered, a short reflection will be provided by an inspector on regulatory standpoint.
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
Supply Chain Security
Anti-counterfeiting strategies
What the agencies can do
What industry can do
Compliance issues
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
Import and Export under new Circumstances
Regulations impacting import and export (e.g. Annex 21, MRA)
Political developments impacting import and export (e.g. Brexit, trade Embargos)
Recording from 31.01./01.02.2024 Duration of Recording: approx. 10 hours 30 minutes
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials