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
Zielgruppe
- GDP Compliance Managers
- Responsible Persons
- Manufacturers, wholesalers, distributors, and service providers involved in the distribution and supply of medicinal products
Zielsetzung
The globalization of the pharmaceutical supply chain has introduced significant challenges to the manufacturing and distribution 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.
Programm
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?
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
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
Transportation
- Key requirements for transportation of medicines
- How to develop and implement a GDP-compliant and cost-effective transportation network.
Case Study for a successful Implementation Approach
- How we approached the new requirements
- Challenges and best practice
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
Premises & Equipment
- What is a must for medicinal products?
- How to plan and implement facility improvement ensuring compliance with the current requirements
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
Short Summary and Take-away Message
- Developing a take-home action plan for the delegates
Q&A Sessions
4 dedicated Q&A sessions ensure interaction and that your questions are answered.
4 dedicated Q&A sessions ensure interaction and that your questions are answered.
Weitere Informationen
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.
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
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference 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.
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.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 01 December 2026, 09:00-17:15 h
Wed, 02 December 2026, 09:00-17:15 h
Wed, 02 December 2026, 09:00-17:15 h
Teilnahmegebühr
| 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
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