David Abraham
QRS-Associates
Referent:innen
Dr Daniel Müller
GMP Inspector
Alfred Hunt
Hunt Pharma Solutions
Heike Gottschalg
Boehringer Ingelheim Corporate Center
Robert Müller
Boehringer Ingelheim
Savvas Koulouridas
Fagron BV
All times mentioned are CET.
Zielsetzung
This Live Online Training provides practical guidance to bring and keep your organisation in compliance with the GDP regulations.
Hintergrund
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.
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.
Zielgruppe
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
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training
Wednesday, 03 December 2025, 09.00 – 17.00 h
Thursday, 04 December 2025, 09.00 – 17.00 h
All times mentioned are CET.
Wednesday, 03 December 2025, 09.00 – 17.00 h
Thursday, 04 December 2025, 09.00 – 17.00 h
All times mentioned are CET.
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.
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.
Programm
Gesamtes Programm als PDF herunterladen
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
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
- Jurisdictions and conflict of law provisions
- Contract law, Technical/ Quality Agreement, Supply Agreement
- 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.
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| GDP Association Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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