Efficient GMP Training Systems - Live Online Training

19/20 November 2024

Course No. 21416



Linda Reijinga

Linda Reijinga


Dr. Katrin Prospero

Dr. Katrin Prospero

Vetter Pharma-Fertigung

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Michael Hopper

Michael Hopper


Dr. Sabine Hauck

Dr. Sabine Hauck

dequra pharma consult hauck, Chair of ECA ATMP Interest Group

Shorni Hardy

Shorni Hardy

BioNTech US


  • You will understand the EU GMP requirements with regard to “Training programmes should be available” and how to interpret them
  • You will learn about the creation and content of a training programme and how training systems are designed and implemented in different pharmaceutical companies
  • You will learn about new training systems e.g. virtual reality
  • You will learn how to optimise the quality of training and how to present your training system during inspections
  • You will learn about the views and expectations of inspectors


The training requirements for employees in the GMP-regulated environment are increasing. Pharmaceutical companies are required to plan and conduct training courses and to evaluate the success of the training.

Requirements for training are (among others) laid down in the Commission Directive (EU) 2017/1572 – “The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified…” and the EU GMP Guide Chapter 2.
How can you implement those regulatory requirements into you daily business? What is the meaning of “effectiveness shall be verified” and what are the consequences for your company?

This ECA course will show you how to operate your training system in a GMP-compliant and effective way from the point of view of inspectorates and pharmaceutical companies. What is currently best practice will be shown on the example of the training management system of different pharmaceutical companies.

Target Group

This training is addressed to executives and employees from pharmaceutical companies and their suppliers who are
  •  Training managers/ training specialists
  •  Responsible for developing, executing and evaluating training programmes

Technical Requirements

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.


Efficient GMP Training Systems - Live Online Training

Seminar Programme as PDF

Design & Delivery of GMP Trainings
  • Use of standards to design and evaluate learning
  • Methods of delivery
  • Blended learning
  • Considering learning styles
  • Engaging the learners
  • Knowledge management
Optimising Quality of Training with a Focus on Virtual Reality Training
  • Changed situation
  • Employee survey
  • Standardized training material
  • Catalogue of topics / publication / booking of training
  • Development of new training methods with a focus on VR
  • Implementation and first experiences with virtual reality training
Presentation of Training Management System during Inspections
  • Preparation for inspection
    - Training on basic behaviour during the inspection
  • During the inspection
    - Presentation of the training system (frequently asked questions by inspectors)
    - Requested documents
Views and Expectations of an Inspector
  • Regulatory requirements
  • Responsibilities
  • Types of training
  • Assessment of Training
Evaluating/Validating Training
  • Kirkpatrick Model
  • Design of assessment materials (based on standards)
  • Methods of assessment & quality assurance
  • Ensuring assessment decisions are objective
  • KPIs
Practical Example:
The Concept of the modular Training System at Vetter Pharma-Fertigung GmbH & Co. KG - Qualification from Day one
  • Modular structure of the training system
  • Training center: Place of learning
  • The pharmaceutical trainer
  • Time management and transfer of knowledge
  • Success control versus control of effectiveness
  • Escalation levels and their mechanisms in the event of repeated deviations
Experience from different Training Systems
  • Development from different training styles
  • Pros and cons of various approaches
  • Suggestions for effective Training
Practical example: Development of TMS at Ferring GmbH
  • Design and structure of the training system
  • Prerequisites / authority requirements
  • Requirements for the software used
  • Implementation of structure and mapping of the training system in a training documentation system (including eSig of training participants, trainers and system managers)
  • Interfaces to relevant systems
  • Paperless documentation.
  • Reports (Controlling of training status / automation of processes)
  • Switching to a new TMS
Practical Example:
  • Training Management System Overview of BioNTech US
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

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

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available
Not available

Do you have any questions?

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

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Testimonials about our courses and conferences

“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