Efficient GMP Training Systems - Live Online Training
Requirements - Implementation - Compliance
18/19 November 2026
Course No. 22699
Speakers
Luigi Scaffidi
Boehringer Ingelheim Pharma
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
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 systems
Objectives
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
Programme
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
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
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.
Further Information
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.
Testimonials
