Speakers

David Abraham

QRS-Associates

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.

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.

Target Group

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.

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.

Programme

The GDP Compliance Manager - Live Online Training

Seminar Programme as PDF

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
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.

This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more

ECA-Member*:	€ 1890,-
Non ECA Member*:	€ 2090,-
EU/GMP Inspectorates*:	€ 1045,-
APIC Member Discount*:	€ 1990,-
GDP Association Member Discount*:	€ 1890,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023

More testimonials

The GDP Compliance Manager - Live Online Training