Printed by: 109435-37 Date: 07.02.

2013

GMP MANUAL

Maas & Peither AG

2.C Training
Base Dr. Michael Hiob
Here you will find answers to the following questions:
Why is training necessary?
How should training be planned and organised?
What is to be taught?
What training methods are there?
What makes a good trainer?
How can you check the success of training?

2.C.1 Purpose of training

The knowledge required within a profession is redoubling increasingly rapidly; the half-life of what was learnt during vocational training is ever shorter. If
companies want to guarantee the quality of their products, the human factor is a crucial variable. Staff must be adequately prepared for the continuously
increasing requirements in their professional environment. Only in this way can the innovativeness of a company as a whole be guaranteed. To this end,
training is a crucial staff development measure. Training is intended to maintain the employees' skill features and adapt them to changed conditions
(further training). In principle, it is based on an existing basic vocational training (e.g. pharmacologist, master pharmacist, engineer, pharmacist, etc.).
In accordance with Article 7 No. 4 of Directive 2003/94, training courses should in principle be executed at the time when the employee first starts their
job and then continuously thereafter.
Training should be planned in the form of approved training programs and must be periodically assessed and recorded. Training of unskilled temporary
staff must be given particular attention. Here, training has the purpose of educating the temporary staff, i.e. of producing a still lacking qualification.
Professional training (e.g. to become a specialist pharmacist) goes beyond internal training and usually leads to a higher professional qualification.

2.C.2 Responsibility for training

Training is a management task. The management of the plant is not only responsible for providing the required personnel and materials required for
training and for releasing the employees from work for training purposes, but it should also use corresponding social and organisational measures to
ensure that the employee can develop fully in accordance with his qualification.
The strategic organisation of training includes the establishment of training guidelines in corresponding process instructions, i.e. that the crucial factors
for the quality of the training are defined. This includes the selection of trainers, coordination of training activities and checking the training system, e.g.
through self-inspections. This is a typical task of the quality assurance department, with the training manager being involved, if available.
The training manager develops the training plan, ensures proper execution of the training events and their documentation and is involved in reviewing the
level of success. The head of production and the head of quality control are responsible for monitoring the qualification of their staff. They stipulate the
necessary technical content of the training, in collaboration with the foremen, and release the employees for the training dates. The respective superiors
review the success of the training on-site and are involved in the practical education of their staff.
Figure 2.C-1 Concept of qualification-based training

2.C.3 Requirements profiles/learning objectives

Efficient training requires that the plant has compiled requirements profiles for the employees of the individual areas. A requirements profile is a detailed
description of the features that are required in terms of the knowledge, capabilities and practical skills required to perform the transferred tasks.
Requirements profiles are usually derived from the employee's job description or the description of their place of work. (Chapter 2.A Place of work and job
descriptions).
As both the plant requirements and the general scientific, technical and legal requirements change, requirements profiles must be adapted as required.
An employee can only fulfil his tasks in accordance with GMP if he fulfils his requirements profile.

In each case, there will be a gap of varying width between the theoretical requirements profile and the employee's actual qualification. This gap must be
closed through training. To this end, the knowledge and capabilities that the employee still lacks must be determined, so that he can fulfil his
requirements profile. In this way, learning objectives are set, which must be achieved during the training. Learning objectives are usually the acquisition of
knowledge and practical skills.

2.C.4 Training contents and target groups

The obligation to undergo training extends to all employees whose activity affects the product quality or the safety of quality-related procedures. This also
includes the persons who are not actively involved in the manufacture and quality control of drugs, but who have an indirect responsibility for the quality,
such as, employees from the registration department, the research & development department, the management (including the board of management) or
the engineering division.
As the employees must be employed based only on their knowledge and capabilities, the training contents must be oriented to the individual
requirements of the place of work. Workplace-related training must be carried out regularly, at least once a year. In addition, training contents that are to
be applied throughout the plant should be communicated.
Figure 2.C-2 gives an overview of the relevant subjects.
Figure 2.C-2 Training subjects/content
Training subject

Content (selection)

Company
introduction

Legal form, company history, product range, business data, working time regulations, employee representation, canteen,
introduction of the departments head

GMP principles/laws GMP Guideline, Drug Law, pharma business regulation, Product Liability Law, finished pack regulation
Quality assurance
concept

Quality term, quality policy, structure of the QA manual, set-up and workflow organisation, continuous improvement process
(CIP)

Documentation

SOP administration, document hierarchies, forms, document handling, approval procedure, archiving, GMP-compliant recording

Sanitation

Cleanliness zones, cleaning/disinfecting procedure,

air lock procedures, handling of open products, personal hygiene, reporting procedure in case of illness

EDP

Training in relevant software, authorised access/password assignment, data backup/data security

Labelling

Labelling of rooms and storage positions, labelling of the operating, cleaning and maintenance status, handling of rejected
material, status labelling on containers

Changes
and deviations

Grading, execution and documentation, causes of deviations, reporting procedure

Safety at work

Protective clothing, noise/dust guard, heavy loads handling, monitor workstations, health check-ups

2.C.5 Training planning

The need to train different employee groups in different subjects and in different frequencies, requires accurate planning. Usually, plants have appointed
training managers to perform this task. The training manager knows the plant and the composition of the staff. He determines the need for training, i.e.
the learning objectives (cf. Figure 2.C-1) in close collaboration with the heads of the different areas (e.g. head of production and head of quality control)
and then executes rough planning (definition of the training subjects and frequencies) and then based on this, compiles a detailed plan (definition of the
training dates and rooms, selection of the training groups and trainers) for the necessary training events. He monitors compliance with the dates and
ensures the smooth running of the events.
Planning and organisation of training events can also be undertaken using electronic training databases. When deciding on the purchase and use of
such programs, the internal function requirements should be defined in advance.
These might include:
Possibility of employee-based scheduling
Subject-based display of the training events in the overview
Organisation of training through the formation of training groups
Target/actual comparison of the training requirements for each employee
Possibility of separate recording and planning of additional training
Possibility of compiling pertinent paper printouts
If the training is planned exclusively by electronic means, in particular the target/actual comparison of training requirements for each employee, then the
computer-assisted system is GMP-relevant and must be checked for suitability before being implemented.

2.C.6 Carrying out

The effectiveness of each training course depends on various factors which, if not taken into account, could endanger the success of the training.
2.C.6.1 External factors
The size of the training room should be appropriate to the number of participants. The temperature, lighting and background noise of the room must not
affect the participants' ability to concentrate. For the presentation of OHP slides, videos or slides, it should be possible to darken the room. Comfortable
seating and a writing surface are actually taken for granted, but time and again we find training rooms with stools and no tables. Equipment, such as
slide projectors or video recorders, should be checked before the training to ensure it is in working order. Sufficient resources, such as flip charts,
pointers, chalk, etc. must be provided, so that there are no undesired interruptions or delays during the training. A sufficient number of participant

handouts and writing utensils distributed at the start of the training ensures that the participants can concentrate fully on the trainer and their attention is
not compromised through the need to write at the same time.
2.C.6.2 Qualification of the trainer
The trainer should be an expert in the training subject. He should know the plant and the composition of the group to be trained (previous knowledge,
work focuses). External trainers and consultants must be informed accordingly well.
Adults learn independently and according to their own pattern. The trainer should therefore have the didactic ability to support the individual participant in
his learning process, encourage him to extend his knowledge independently and not try to force his learning concept on the participants. For this reason,
the question of the trainers or teacher's qualification must not be taken lightly, as otherwise the training event can easily turn into an aloof self-projection
of the trainer, which is of benefit neither to the plant nor to the participants (cf. Figure 2.C-3).
In order to enable a uniform teaching level, the group to be trained should be composed of people with the same level of education and experience.
Figure 2.C-3 Requirements of a good trainer
What makes a good trainer?
Extensive technical knowledge and experience
Didactic ability, in particular in terms of adult education
Preparation of the training in line with the target group
Clear, comprehensible structure of the presentation
Sensible and experienced use of media
Ability to motivate, humour, creativity
Self-critical control of learning objectives

2.C.6.3 Training methods

There are numerous ways of carrying out training courses. Each method, if used predominantly or exclusively, is not effective enough. It is often forgotten
that for people who completed their studies decades ago, a training course represents an unfamiliar strain, which leads to quick mental exhaustion. This
is why corresponding rest breaks are necessary. The trainer must therefore bring knowledge and a grasp of methodology and teaching tempo.
Lesson
The classical lesson form - a teacher speaks, the participants (pupils) listen - is appropriate in principle, if dealing with the communication of subject
matter. The teacher can adjust to the listeners in terms of language, gestures and with the available teaching resources (e.g. blackboard, flipcharts,
overhead projector) and adapt the lesson tempo accordingly. The extent to which the participants can influence the training course through their own
questions or contributions also depends on the teacher.
Working groups
Working groups are generally used to obtain more in-depth knowledge and require previous knowledge. The advantage of working groups is that each
individual participant is more intensively involved in the lesson, in comparison with other methods. The group is intended to fulfil the task jointly, e.g.
using a case study, which is very close to the reality of the working world. The group members can contribute their personal knowledge and experiences
and thus teach each other mutually. The inhibition to ask questions is significantly lower in working groups than in the classical lesson style. Working
groups in which individual participants dominate the group work due to their headstart in knowledge or experience are problematic. In any case, the
results of the working group must be summarised and evaluated by the teacher.
Role plays
Role plays are particularly suitable for investigating personal behaviour and learning new behavioural patterns. The employees' social competence is
encouraged through the associated improvement of the ability to communicate and work in a team.
Slides, films, videos, CD-ROM
All audio-visual techniques have the advantage that they make the subject matter more visible in the true sense of the word, and thus also more easily
accessible. The tempo, in which the subject matter is communicated is fixed, which can sometimes mean that individual participants cannot always
follow the presentation. Therefore, such presentations should always be accompanied by an introduction and conclusion of the learning objective.
Written learning programs
Learning programs in the form of text books allow knowledge to be communicated through independent study. The user can determine the learning
tempo individually and review his success himself through corresponding tests. The suitability of this program depends greatly on how exactly it is
tailored to the specific requirements of the employee.
E-Learning
A series of computer-assisted, interactive learning programs is now available on the market. These software packages often contain small video units
combined with text or audio teaching contents, allow knowledge to be tested via multiple choice tests or case studies, and thus enable online success
monitoring. Learning should be particularly memorable due to the fact that several senses are addressed by this medium. If necessary, adaptation to the
respective plant is possible through editor programs.
The advantages for the company through the use of E-Learning are:
Reduction of the training costs and time off
Consistent quality of the training measure
Prevention of scheduling or personal bottlenecks
Methodical enrichment

The advantages for the user are:

Self-determined learning (place, time, tempo, learning path)
Self-checking instead of external checking (no worry about gaps in knowledge)
Consultation and repeating as required
High motivation through interaction and multimedia
Careful group analysis is crucial in selecting and using this medium. The software can only be used effectively if it is tailored to the needs of the plant.
The conditions for saving personal data in the context of software usage should be agreed with the Works Council (cf. Chapter 2.C.7 Reviewing the
training and the training system)
On-the-job-training (OJT)
On-the-job training is usually assigned to the foremen. The employee to be instructed should learn how to carry out and document his tasks based on
the relevant (standard) operating procedures. The method is carried out according to the following principle: Explain, demonstrate, copy, correct.
The foremen often consider the task of teaching to be inconvenient additional work. It is therefore all the more important that the foremen not only develop
a quality awareness for the product, but also for the level of education of the employees, and are accordingly trained in the technique of teaching.
Ultimately, it is they who should first notice training deficits and the need for additional training.
External training
External training events are a good opportunity to find out about the latest knowledge and state of technology and offer the possibility of exchanging
information with other companies.
A distinction can usually be made between seminars and conferences:
At seminars, a subject is presented to a defined target group by means of different presentations and sometimes also through working groups, podium
discussions or round-table discussions. When choosing these seminars, it is crucial that the employee first checks whether or not he belongs to the
target group being addressed, as otherwise his own field of work may not be dealt with in sufficient detail. The trainers, who's names can usually be
taken from the advance notification of the seminar, can also give information on how in-depth or practical the communication of the subject is anticipated
to be. If the focus of seminars is on working groups or role plays, you should definitely ask the seminar provider the maximum size of the groups
beforehand. The learning effect in working groups and role plays is highly dependent on the extent to which the individual can participate. Working groups
and role plays with more than eight participants usually offer the individual group members too little active participation.
Conferences usually aim to present the latest knowledge on a certain subject. A conference should therefore be considered less as a training event and
more as an information event. At a conference, you should expect to find out about the latest information on a specific subject from experienced
specialists. When selecting this type of event, the same principles apply as for seminars (target group, trainers) and also the question of whether or not
the conference subject is relevant for your own plant.

2.C.7 Reviewing the training and the training system

Article 7(4) of Directive 2003/94/EC demands that the effectiveness of the training be reviewed. Chapter 2, No. 9 of the EU GMP Guideline assumes that
the implementation of the training is periodically assessed in practice. Accordingly, the plant must review the qualification of its staff. At the fore of this
review is the review of the level of success, which is carried out immediately after or within a specific time interval after the training. This should prove that
the training carried out was suitable to achieve the intended learning objectives or to ascertain a potential need for additional training.
If personal data is saved during the review of success (i.e. individual information on personal or business relationships of those concerned), prior consent
of those concerned must be obtained ( 4 (1) of the Federal Data Protection Act).
The plant is authorised to execute personal reviews of success. Before executing personal reviews of success, however, the Works Council must be
involved and its approval must be obtained. If aspects of data protection law were taken into account, the Works Council can usually not refuse its
consent, as the plant is legally obligated to ascertain the qualification of its staff. The Works Council is explicitly obligated to promote professional
training.
The effectiveness of the training event as a whole can be determined via anonymous reviews of success, but an ascertainment of the individual need for
additional training is not possible in this way.
In practice, various direct and indirect methods have prevailed:
The classical knowledge survey as a written question/answer test or multiple choice test
The online survey and evaluation in software training programs
Oral testing by the teacher or superior
The observation of behaviour at the place of work by superiors
The review of documents compiled by the employee for conformity with the requirements taught
The evaluation of employee-dependent error statistics
In addition to selecting the method used to review success, the timing of the review of success is also crucial. A survey test carried out shortly after a
training course can check if the training objective, namely the communication of the teaching content, was achieved. However, the result does not
guarantee that the employee will still remember the teaching content after three months have passed. It doesn't take long to store facts in your shortterm memory, but it takes quite a bit longer to also keep them in your long-term memory. Anyone who has already learnt a poem by heart has had this
experience. Reviews of success should therefore also be carried out after a certain time delay and not directly after the training
A review should also be carried out to check if the employee has only remembered the knowledge as a collection of facts, or if he is able to apply the
knowledge, i.e. independently draw conclusions from the newly acquired knowledge, make decisions and transfer the knowledge to the plant. A review of
success should therefore not only check the technical competence, but also the method and handling competence (cf. Chapter 2.B.1).
In addition to assessing the individual employee, the training system as a whole should also be reviewed (cf. Figure 2.C-4).
Figure 2.C-4 Quality assurance of the training system

To assess the effectiveness of the training system, the checklist in Figure 2.C-5 can be used.
Figure 2.C-5 Checklist for reviewing the training system
Checklist for reviewing the training system
1. Requirements profiles
Have requirements profiles been compiled and approved?
By whom and how are they checked for plausibility and for how up-to-date they are?
2. Learning objectives
Are workplace-related learning objectives defined for employees?
By whom and how is the achievement of learning objectives reviewed?
Is there a subject catalogue for basic training of new
employees, tradesmen and visitors?
3. Planning
Have training dates, venues, target groups and training subjects been defined?
By whom and how is compliance with the training plan reviewed?
4. Carrying out
Are suitable rooms and media available for training courses
How is it ensured that the trainers are sufficiently qualified?
Is every training course documented in a traceable manner?
5. Review of success
By whom and how is the success of the training reviewed?
Is a need for additional training recognised and consistently pursued?

2.C.8 Documentation
All training activities are to be documented in a traceable manner. Documentation can be made in paper form or via EDP. Records of the key aspects
mentioned in Figure 2.C-6 should be available.
An evaluation of the training documentation should be possible under the following criteria:
Which (additional) training was carried our per employee in a defined period of time?
When were training courses held for specific subjects?
What training subjects were taught in a specific period of time?
How was the effectiveness of the training measures reviewed?
Figure 2.C-6 Contents of the training documentation
Key aspect

Documentation contents

Job description of the training manager Tasks, deputisation regulations, authorities

Training plan

Subjects, times, training groups

Training execution

Venue and duration, training contents, list of participants, trainer, reference to resources and materials

Evaluation

Success checks, self-inspection of the training system

Summary
Regular training of employees is a significant requirement for employees being able to complete their tasks in accordance with GMP.
Training events must be planned carefully, be executed in a methodic manner, and be reviewed in terms of their success.