Linda Reijinga
Ferring
Referent:innen
Dr. Katrin Prospero
Vetter Pharma-Fertigung
Dr. Franz Schönfeld
Regierung von Oberfranken
Michael Hopper
GXPPRO
Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Shorni Hardy
BioNTech US
Zielsetzung
- 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
Hintergrund
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.
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.
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.
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 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.
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.
Programm
Gesamtes Programm als PDF herunterladen
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
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,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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