GDP Compliance Managers and Responsible Persons from organizations such as manufacturers, wholesalers, distributors, and service providers involved in the distribution and supply of medicinal products
Objectives
This Live Online Training provides practical guidance to bring and keep your organisation in compliance with the GDP regulations.
Background
The globalization of the pharmaceutical supply chain has introduced significant challenges to the manufacturing and distribu- tion of medicinal products across various markets.
While the EU GDP Guidelines have been in force since 2013, many questions continue to arise regarding their practical implementation. The guidelines emphasize the importance of a robust quality management system, supported by thorough risk assessments and effective controls.
This two-day Live Online Training is specifically designed to provide the latest insights into current regulatory expectations and standards for Good Distribution Practice (GDP). Participants will gain practical tools and guidance to identify gaps in their Quality systems and to develop and implement effective action plans.
Programme
Welcome and Introduction
The (new) GDP Guideline: What was it all about?
Background to development and revision of the EU GDP Guidelines
Overview of structure and content
What is the impact on industry and other stakeholders?
Quality Management System (QMS)
What is a QMS and why do we need it?
What does an effective QMS look like?
How to develop and implement an effective QMS
Operations
Qualification of suppliers and customers
Receipt, storage and return of medicinal products
Deviation and Complaint Management in a wholesaler facility
How to conduct a gap analysis, develop plans and implement the new requirements
Questions & Answers Session I
GDP Inspection Findings and what to learn from them
Findings and their Ratings
Examples from manufacturers, wholesalers, storage facilities and transport deviations
Personnel
Competency requirements for GDP personnel
Overview of the role and responsibilities of the Responsible Person
Necessary documentation
Training matrix and managing continuous training
Questions & Answers Session II
Premises & Equipment
What is a must for medicinal products?
How to plan and implement facility improvement ensuring compliance with the current requirements
Transportation
Key requirements for transportation of medicines
How to develop and implement a GDP-compliant and cost effective transportation network.
Contracts in the Global Supply Chain
International laws and systems – how they work and fit together
3PL Providers: two bilateral agreements or one tripartite agreement?
When things go wrong
Questions & Answers Session III
Outsourced Activities
What is an outsourced activity?
How to set priorities to audit, approve and manage Service Providers
How to develop and manage contracts and agreements
Case Study for a successful Implementation Approach
How we approached the new requirements
Challenges and best practice
Questions & Answers Session IV
Short Summary and Take Away Message
Developing a take home action plan for the delegates
Four Q&A sessions ensure interaction and that your questions are answered.
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT) ECA Members € 1,890.- European GDP Association Members € 1,690.- APIC Members € 1,990.- Non-ECA Members € 2,090.- EU GMP Inspectorates € 1,045.- The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
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Testimonials
