Training in a GMP Environment

Training in a GMP Environment

Barcelona, Spain

Course No 9389


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Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Michael Hopper, GxPpro
Linda Reijinga, Ferring
Bernd Renger, Bernd Renger Consulting
Martin Wesch, Wesch & Buchenroth, Law Office


You will understand the EU GMP requirements with regard to “ Training programme should be available” and how to interpret them
You will learn about the content of a training programme and who is responsible for what
“The effectiveness of a training programme should be verified”. What does this mean? You will get to go through a case study from a pharmaceutical company and you will understand the limitations from the legal point of view
You will learn how to optimise the quality of training and how to present your training system during inspections
You will learn how to write standards that can be used to determine competence of Trainees


Requirements for training are laid down in the EU Directive 2003 / 94 – “The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified…” - and in the EU GMP guide in chapter 2 - “Personnel should be qualified and manufacturer should provide training for all personnel whose activities could affect the quality of the product. Training programmes should be available”

How can you implement these general 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 support you with information from practitioners as well as with information from the legal base. It will show you how to operate your training system in a GMP compliant and effective way and what is current best practice.

Target Group

Managers and staff from pharmaceutical companies, Training Managers, Training specialists and suppliers who are responsible for developing, executing and evaluating training programmes.


European Regulations
Data security laws
Cooperation with Work Council
Assessment of effectiveness

Training needs Analysis
Sources of Information
Processes for collecting data
Structuring Training
Role Profiles/Job Descriptions
Training vs Development & CPD
Human Error
The learner journey
Business Objectives

Design & Delivery of Learning & Development
Considering Learning Styles
Blended learning
Engaging the learners
SOP Training & Human Error
Methods of delivery
Knowledge Management

Efficient Routine GMP Training Programs
Classroom Training versus e-learning or read and understand
Training of SOPs – in full or partial?
How many SOPs do we need to know?
Refresher training – how often?
Is there a need to align GMP training with business objectives?

GMP Training versus Technical on the job Training
Can technical on the job training and GMP training be separated?
Side by side learning of new technologies using mentor systems
Training runs – how many times?
Sharing experience – how to formally document correctly
How to qualify mentors?

Practical example: TMS of Ferring GmbH
Structure and organization of TMS
Revision of process / organizational form / responsibility structure
Revision of TMS software
Implementation and adaption of defined Training system into the TMS system (including eSig of participants, trainers and system responsible)
Paperless documentation
Factors of success

Optimising Quality of Training
Online Questionnaire
Initial training
Repetitive training
Reading training vs Face to Face
Frame conditions
Future ideas
Trainer function
Development of training catalogue
Objective: gain general knowledge
Topic based catalogue
Cross departmental required and optional
Organization of booking in courses (automated)
Implementation of internal trainer pool
Voluntary / feel qualified
Structure of training material

Evaluating Training Presentations
Kirkpatrick Model
Assessing Competence
Vocational Qualification
Methods of assessment

Presentation of Training Management System during Inspections
Preparation for inspection
Preliminary measures
Training for organization and behaviour during inspection

Presentation of Training system / requested documents
Structure and organization of Training system
Questions and focus
Requested documents

Design & Delivery Workshop
How Training is designed can have a significant impact on the transfer of learning to the trainee and subsequently, the effectiveness of your workforce. During this workshop you will have the opportunity to consider how to Design training based on Training curriculum.

Evaluating Training Workshop
Standards provide an excellent method of evaluating learners competence. Competence is a defined as a combination of skills and knowledge required to perform defined tasks, so measures the transfer of learning into the workplace. Standards also ensure that the evaluation is objective as all trainees need to demonstrate that they can work to the same standard. During this workshop, you will have the opportunity to develop standards as a tool for evaluating Training.

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