Luigi Scaffidi
Boehringer Ingelheim Pharma
Referierende
Linda Reijinga
Ferring
Dr Katrin Prospero
Vetter Pharma-Fertigung
Dr Franz Schönfeld
GMP Inspector
Michael Hopper
GXPPRO
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Barbara Kopf
Takeda Manufacturing Austria
Highlights
- Optimising Quality of Training with a Focus on Virtual Reality Training and AI
- Views and Expectations of an Inspector
- Practical Examples
- Views and Expectations of an Inspector
- Practical Examples
Zielgruppe
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 systems
Zielsetzung
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.
- 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 and how AI can support the training development
- 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
Programm
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
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
- Supporting the efficiency of GMP training with AI
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 Concept at Boehringer Ingelheim,
Case Study: Aseptic Facility in Ingelheim
Case Study: Aseptic Facility in Ingelheim
- Classic vs. modern training technologies
- Periodic re-training
- Assessment of training
- Place of playful learning: Training center
Use of AI in GMP Training Development - Practical Tools and Use Cases
- Training concept development with AI support
- Content creation with documents as input
- AI-assisted generation of quizzes and knowledge checks
- Prompt techniques for high-quality training output
- Compliance considerations: data privacy, approved tools, human review
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.
Weitere Informationen
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 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 EUR
APIC Members 1,990 EUR
Non-ECA Members 2,090 EUR
EU GMP Inspectorates 1,045 EUR
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.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Sarah Schmidt, +49 62 21/84 44-16, s.schmidt@concept-heidelberg.de.
Questions regarding organisation:
Ms Julia Grimmer, +49 62 21/84 44-44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 18 Nov 2026, 09:00-17:00 h
Thu, 19 Nov 2026, 09:00-17:00 h
All times mentioned are CET
Thu, 19 Nov 2026, 09:00-17:00 h
All times mentioned are CET
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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