Training in a GMP Environment

Programme

European Regulations
GMP-Requirements
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
Competence
Training vs Development & CPD
Human Error
The learner journey
Business Objectives

Design & Delivery of Learning & Development
Presentation
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
trainings
Organization of booking in courses (automated)
Implementation of internal trainer pool
Voluntary / feel qualified
Availability
Structure of training material

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

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.