GDP - how to get you there

15-17 March 2016, Barcelona, Spain

Seminar-Nr. 15131


This education course provides practical guidance through workshops on how to perform gap analysis, prepare plans for implementing systems and procedures to bring your organisation in compliance with the GDP regulations.


The globalisation of the pharmaceutical supply chain has created new challenges for manufacture and supply of medicinal products in various markets, resulting in reduced control and increased security risk to the products.
The EU GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain. The new requirements have been effective since September 2013. These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls. Do you think you are compliant with the new requirements?
This two day tutorial has been designed to bring you up-to-date with the current regulatory thinking and standards for Good Distribution Practice (GDP) and to provide you with tools and guidance to help you with identifying the gaps in your quality systems compared to the new requirements and planning and implementing the actions required.


Managers and executives from companies involved in the distribution and supply of pharmaceutical products.


GDP - how to get you there

Gesamtes Programm als PDF herunterladen

The Inspectors Point of View
The new GDP Guidelines: What is it all about?
Background to development and revision of the new EU GDP Guidelines
Well-known or new: A summary of the most important changes
A look into the crystal ball: 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

A step-wise Approach:
Workshops and interactive Sessions

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

Key requirements for transportation of medicines
How to develop and implement a sGDP-compliant and cost effective transportation network.

Premises & Equipment
What is a must for medicinal products
How to plan and implement facility improvement ensuring compliance with the current requirements

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

Competency requirements for GDP personnel
Overview of the role and responsibilities of the Responsible Person
Necessary documentation
Training matrix and managing continuous training

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 Studies
GDP – how we got there
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

Lessons learned and Action Planning
Summary and Take Away Message
Developing a take home action plan for the delegates

Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Liste aller Seminare.

Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in der Liste aller Aufzeichnungen.

Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset


Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023