Professional Documents
Culture Documents
Published by
Research Quality Association
3 Wherry Lane, Ipswich
Suffolk, IP4 1LG
UK
November 2015
ISBN 978-1-904610-36-6
Copyright 2015
Research Quality Association
All rights reserved
Foreword
The Education and Training Committee of the Research Quality Association (RQA)
has been helping shape the Associations training and education strategy.
A subgroup of the Committee has been tasked with developing a best practice guide
for training and development of personnel working in good practice (GxP) regulated
environments. This guide is also intended for those working in non-regulated
environments, who may find the ideas introduced useful in shaping their training
systems and processes and developing best practice GxP-compliant frameworks.
The guidance is directed towards trainees, management and trainers, and anyone
else involved with training and development. It is based upon the pooled knowledge
and resources of the authors and reviewers working in Contract Research
Organisations, the health research environment and the pharmaceutical industry.
Personnel receiving and seeking training make a choice. They either passively
receive mandatory training and information, or actively engage in developing
their training and competency programmes, or a mixture of both. However, by
engaging in their own training and development they are more likely to benefit from
it and demonstrate that benefit by applying the learning to their everyday roles,
responsibilities and tasks. Others, such as trainers, may communicate those learning
outcomes and benefits, further adding value to the organisation and fostering a
quality improvement culture.
1
Scope and objectives Acknowledgements
This introductory booklet contains the core ideas This booklet has been developed by the following
underpinning the development and management members of RQAs Education and Training
of effective training, development and competency Committee:
systems and programmes, however small or large.
Katarina Eghan Yasser Farooq
It discusses the drivers behind and principles of
training, development and competency management. Linzi Gillbanks Alison Hunter
It also touches upon the various training
Louise Mawer Belinda Pierce
methodologies and contains some useful tips for
trainers. This first booklet will be followed by Part 2 Jennifer Wilkinson
which will focus on more advanced ideas and will be
of interest to colleagues who would like to know not Additionally, Carl Lummis, RQAs Coordinator
just the what, but also more of the how and why (Learning & Development), was instrumental in
of training-related matters. progressing the booklet through to publishing.
Valuable support and direction were also provided
This guidance has been developed with best practice
by Lee Monk, the Education and Training Committee
in mind and it is intended that the reader considers
Chairman.
the context of how this guide fits within their own
individual organisational structure and needs. Those
new to the concepts can use the ideas to shape their The authors would like to extend their gratitude to
own understanding of the principles of training and the following external contributors and reviewers:
competency management. Sarah Jones Catherine Nelson
This guide aims to provide a solid overview of a wide Sara Parish-Wall Sian Thornley
topic in just a few pages. It comprises outlines of the
principles and best practice, supported by tools such Fiona Waddell Andrew Waddell
as example forms and templates that can be adapted Louise Weber Kath Williams
for use within your own organisation. A glossary of
terms used throughout the booklet has been included and RQA committees supplying regulatory
to aid common understanding of the terminology. knowledge.
Additionally, the booklet contains useful resources for
further reading.
2
Contents
3
1 Introduction to training and
competency management
1.1 Purpose of training and GxP regulations and guidelines make it clear that
development training is fundamental to the good practice quality
management systems (QMSs). (See Appendix 1 for
Before we can consider the broader aspects of detail on the relevant requirements.) Furthermore,
training and development, it is important that we GxP regulations and guidance place responsibilities
understand the difference between training and on management to ensure there is a sufficient
learning. number of staff with adequate education, skills and
Learning is the acquisition of skills and knowledge experience to perform their tasks. However, training
through training, education and experience. and education are driven by organisational needs
as well as those of the regulations. Best practice
Training seeks to impart a set of skills with a also dictates a responsibility of the individual for
specific outcome, without the necessity of the ownership of their development plans, identifying
trainee to understand why they need to act in training needs, ways in which those needs can be
a specific way. (Compared to education which met, and development targets to help them become
results in an individual having learnt skills and an high performing individuals.
understanding why actions are taken).
Establishing a robust competency and training
Therefore, in order to ensure competency is gained, framework need not be a big job; there are no
these elements cannot be considered without regulatory prescribed ways to achieve the end
the other. goal: competent and engaged teams and individuals.
In addition to skills and knowledge gained through This gives each organisation flexibility to ensure the
training and education, attitudes and behaviours are practices developed are fit for purpose and based
also important elements that have to be considered on each organisations needs, wants and individual
in holistic approaches to individuals training and circumstances.
development. The outcome from successful training
would be an individual with a skill (technical or soft
skill e.g. communication, leadership or performance
management) and the associated knowledge and the
ability and willingness to apply that skill (attitude and
behaviours) to undertake their role to the required
performance standard (competency).
Efficiency
Effectiveness
Evidence of competency
4
1.2 Organisational and individual need For training to be seen to be effective there must be
for training an observable or measureable impact that assists
the organisation in achieving its goals and strategy,
According to the Business Dictionary (2015), training whether that is regulatory compliance, improved
is defined as Organised activity aimed at imparting processes, reduced error rates or repeat work.
information and/or instructions to improve the
recipients performance or to help him or her attain a
1.4 Training evaluation and assessment
required level of knowledge or skill.
Training evaluation and assessment are an integral
Before training plans can be developed, it is important
part of all robust training strategies.
that the following questions are considered:
Evaluation is measuring the success of the
Organisational need: What are we training staff
training on achieving the desired learning
for? What is the organisational need or skills gap
outcome and objective and meeting the desired
identified? What is the risk of not conducting the
organisational need.
training?
Assessment is measuring whether a participant
Persons need: Who will receive training and what
has achieved the desired end result and is
is their existing level of knowledge or skills?
competent.
Task: What specific tasks are required to be
performed and what is the required skill level? Learning evaluation (Kirkpatrick, c2009-2015)
Performance: How do we ensure staff work to an
acceptable standard? Is there a need for retraining
Level 1 Did the delegate like it?
for those with a shortfall in skills or performance? Reaction
Legal/regulatory requirements: Is training aligned
and doesnt contradict legal or ethical standards?
Level 2 Did the delegate learn?
Suitability: How will the training be delivered and Learning
how will we know if it is effective?
Cost: What is the return on investment, both to Level 3 Did the delegate use it?
the individual and the organisation? Behaviour
Only when the above questions have been
considered can training plans be deemed robust and Level 4 Did the training impact the
add value to both the organisation and the individual. Results bottom line?
If there is nothing to change, perhaps training is
not necessarily the solution. In a situation such as What is the return on the
this, it may be acceptable to provide information ROI learning investment?
regarding the task, based on previous experience
and a demonstration of competency (proof) that an Source:
individual already possesses the necessary skills and http://www.kirkpatrickpartners.com/OurPhilosophy/TheKirkpatrickModel
knowledge (e.g. during refresher GxP training).
1.5 Procedural and other related
1.3 Outcomes of training documentation
Learning is about creating a change: improving As with other aspects of regulated activities, training
the current level of skill, knowledge, attitude or and competency management-related processes and
behaviour. The provision of training is not about procedures are required to be well defined within
identifying training courses, but appreciating that it is the organisations QMS in, for example, Standard
a personal learning experience, putting the needs of Operating Procedures (SOPs). The processes for
the individual into context and making training timely determining training needs, delivering the training
and relevant to organisational objectives and personal and evaluating its effectiveness must be clearly
development goals (typically outlined in a personal described and followed. Objective evidence that the
development plan). Individuals should be active in processes have been followed and their outcome
their development and training, and there should be was successful must be retained and made available
objective measures of effectiveness to check that for review (e.g. by regulatory authority inspectors,
the training delivered a successful and compliant auditors, management or trainers). Appropriate
outcome for the individual and the organisation. archiving of documentation is required following an
employees exit from the organisation.
5
2 Identifying organisational training
and competency requirements
We
find that firms that invest in workforce training
tend to have higher productivity
(Cheese, 2015, p.2)
Most organisations would agree that their staff are Therefore, the responsibilities of the organisation
their most valuable resource and they therefore invest include:
in their staffs training and development. Ensuring that individuals have regular opportunities
Thus, the objectives of any organisations training and to discuss training and development needs
development policy will enable staff to: (and reflect on courses already taken) with
management/trainers/mentors.
Acquire the knowledge and skills to enable them
Establishing priorities in relation to competency
to perform effectively in their roles.
and training and making appropriate provision
Enhance their performance. to meet them within the resources and
Respond effectively to the demands placed budgets available.
upon them by internal and external changes and Considering training needs which will assist
developments. staff to respond effectively to internal or
Develop their careers effectively within the external changes.
organisation and beyond. Helping identify appropriate opportunities for
When an organisation develops staff training training and development.
objectives it is important that wherever possible, Making appropriate provision for the release of
the criteria by which the trainee can be considered staff from their duties to undertake training.
competent following the training can be considered Ensuring equal opportunities to access training
to be SMART (Specific, Measurable, Achievable, and development.
Realistic and Time-based).
Ensuring time for post training that the individuals
have the opportunity to put into practice what
theyve learned.
Reflection to allow all parties to consider the
journey taken and the lessons learned.
Experience
Generalisation
6
Commonly, the same type of training is provided to an evidence-based evaluation of past performance
individuals involved in conducting an activity (e.g. within a defined period takes place (successes and
the conduct of a clinical trial, the manufacture of a areas for improvement are both considered). This is
medicinal product or working in a specified area or a two-way process whereby goals and objectives
laboratory) without considering if similar training has are developed and agreed by both parties. This
previously been received by the individual (perhaps results in a forward-looking plan of actions, including
as part of another trials set up, in relation to a personal development and training targets. When
similar product recently manufactured, or similar training objectives are established they can be
test methodology). A tick is often marked in the structured into a training plan that helps identify how
individuals training record to confirm that the training to meet the objectives and estimate the financial and
has been imparted to the individual, but it is not resource costs. At the start of employment, goals
always followed by the individuals (self-) assessment and objectives are typically defined in an induction
of their ability to perform a particular task/job, based programme/plan.
on the training provided. Individuals tend to be the
recipients of training and information but emphasis 2.1 Competency management systems
is not often given to their involvement in the
development of their training programmes and self- In order to fulfil the organisational responsibilities and
assessment of their effectiveness (i.e. competency). achieve the organisations objectives, the concept of
competency management is often adopted. There is
Quality by design principles of quality management no consensus on an agreed definition of competency
offer an alternative to a tick box approach to the (we have included a suggestion for such a definition
signing off of training records and these principles in this booklet section Glossary and definitions) but
have been taken into account when developing the dimensions of competencies are generally seen
this guide. (Refer to section Further Information as demonstrable and assessable, based cumulatively
and Additional Reading for further resources on the on knowledge, skills and behaviours required to
quality by design topic). perform a particular job to a pre-determined standard.
Examining the organisational needs and objectives Key competencies are often used in the creation
against the skills and training needs of the of an organisations recruitment and selection
individual is commonly discussed during Personnel procedures in the form of job descriptions
Development Reviews (PDRs) or appraisals. The (Ref. Appendix 3).
PDR or appraisal is a planned meeting between line
management and the individual in which (typically)
Competence
Source: Components of competence Adapted from RSSB: Good practice guide of competence development
7
Typically, the analysis of competency requirements 2.2 Training management systems
would identify:
Training Management Systems are typically part
Competencies needed to implement the overall of the competency management systems and are
strategy of the organisation. used to implement any training plan by managing
Specific tasks carried out by individual staff training requirements, work experience, qualifications
members. and assessments of individuals in an organisation.
Training is based upon needs or requirements, the
Competencies required to carry out those tasks
catalyst for which can be:
effectively.
Available competencies within the organisation, Additional new staff employed.
i.e. existing skills. Any changes to regulations or introduction of new
Gaps where the identified required competencies regulations.
are mismatched against the existing skill sets Role changes by staff, either temporary or
(Gap Analysis). permanent.
How competencies will be measured. Revisions to the organisations processes or
Measures taken to implement or contract the equipment renewal or modification.
required training to develop the competencies. Monitoring, review, audit or regulatory inspection
Communication mechanisms to ensure identified problems.
organisational and individual understanding of Staff changes that require or prompt re-training or
the competencies, gaps and actions taken in refresher training.
remediation (when necessary). Continuous professional development and training
of existing staff.
Training Needs Analysis (TNA) can be used to
formally identify the above in a timely manner. The
TNA should detail how any training is designed,
delivered, evaluated and recorded. This will
determine whether the training is required, it will be
within budget, and meets the overall strategy of the
organisation.
Risk-based Training Needs Analysis identifies how
risks that are associated with tasks can be minimised
through learning, assessment and competence
management activities, and used to support decisions
relating to competency and training.
Competency management
8
3 Roles and responsibilities in training
and competency management
I wonder what
training I am
going to receive?
It is important to acknowledge that training and In the GxP environment, management oversight of
development programmes should have the individual different aspects of the organisation is commonly
at its centre. It may be considered natural or even mandated by regulation and/or associated guidelines.
acceptable in a heavily regulated environment to have In the case of training, management should be an
complex training plans to verify the individuals ability enabler; helping to source, develop and deliver the
to perform a job. This may not be optimal for the right type of training by optimal means.
organisation when considering the organisations
Managements focus should be on ensuring that they
resources and financial budgets. Internal and external
provide the necessary resource to support their staff
(self-) inspections, audits and quality control activities
and help them develop in a number of ways, be it
often uncover non-compliances/deviations/non-
knowledge, technical, managerial or soft skills. There
conformances (for example with protocols, SOPs and
are different learning styles that individuals possess
manufacturing standards), which are often attributed
and the one size fit all approach generally does not
to human error.
work very well.
To foster individual engagement and promote
Management have a responsibility for checking
continuous improvement, it is desirable for
the understanding and competency of their direct
individuals to be involved in designing and evaluating
reports. Mechanisms to achieve this include (but
their own training and competency programmes
are not limited to) one-to-one discussions following
(with the support of management, Subject Matter
training, confirmation by examination (either during
Experts (SMEs), mentors and peers), and for them
or following the training), peer review or on-the-job
to actively self-assess and critically appraise the
feedback from SMEs or mentors.
training received.
Management also have responsibility for supporting
trainers. Training takes time and resources during
the planning, delivery and assessment phases.
Management should take this into account, especially
whenever a trainer has a dual role within an
organisation.
Leadership is everything! When we implement
quality systems, success is directly proportional to
the actions of the top management. The same is true
in training. Organisations which show the effects
of training, education and learning through sincere
practice benefit at the expense of those who see
training as a necessary evil.
9
3.3 The role of the trainer 3.4 The role of a mentor/coach/buddy
Processes and
Procedure Training
10
4 Developing training and competency
programmes
11
Training directed to a role will vary with the seniority 4.2 The training life-cycle
of the role and tasks to be assigned; those starting
in a specific area (in the absence of directly An individuals training and development
transferrable skills) may have more gaps in their requirements within an organisation generally
skills and experience. However, where possible, commence at induction, when it is necessary
learning should be phased over the short, medium to ensure the individual reaches an acceptable
and long term, with defined measurable outcomes competence standard to fulfil the basic job
and targets in order for development to be tangible requirements as quickly as reasonably possible.
to both management and the individual in training. They continue through employment with periodic
Consideration should be given to interim targets and review and evaluation as the needs of the
measurable outcomes when a specific outcome organisation, regulatory environment and strategic
(such as sign-off to perform the activity unsupervised) directions change. Additionally, an individuals training
may take a relatively extended period to maintain and development needs change as their role (or the
an individuals motivation and verify progress (for departments function) changes.
example where necessary to management and/or Periodic refresher training is mandated by certain
Human Resources as part of a probationary period). regulations, for example, the current Good
Manufacturing Practice (GMP) requirements of the
4.1.3 Needs-directed training United States Food and Drug Administration (US
Training directed to the identified training needs FDA) laid down in the Code of Federal Regulations
of the individual in consideration of their prior (CFR) Title 21 Part 211 and GxP guidance such as
skills, knowledge and experience, and the roles, Pharmacovigilance Quality Management System
responsibilities and tasks they will be required to expectations defined by the European Medicines
perform routinely. Additionally, needs-directed training Agency (EMA) Good Pharmacovigilance Practice
may be identified during ad hoc activities, or when (GVP) Module I.
reviewing the overall skill set of a department or Prior to leaving an organisation, it is prudent for the
function where a skills gap is identified. employer to verify the records and assessments
it retains on an individual are complete as this is
considered supporting documentation, necessary
to confirm competence when reconstructing
studies or tasks.
Training life-cycle
Recruitment
Needs-based Induction/
training on-boarding
Regulatory
training
12
4.3 Competency assessment at 4.5 Induction/orientation
recruitment programmes
Identifying staff with the appropriate entry-level Training provided as part of an induction programme
education, qualifications, skills and experience usually includes mandatory training and role-specific
through recruitment processes requires that the training for successful completion within a specific
roles, responsibilities, tasks and necessary personal timeframe typically aligned with completion of any
attributes for a particular job function are defined, and applicable probationary period.
in the GxP environment, documented. This role and
Training provided will normally include familiarisation
person specification should be used as a template for
with mandatory employment conditions, policies and
recruitment, and as a standard during the interview
procedures, in combination with online and on-the-job
and induction processes.
assignments and assessments necessary to perform
Assessments include verbal questioning of basic tasks (i.e. for the individual to function at a basic
experience, written assessments and/or evaluation level in their role, fulfilling an organisational need).
through practical scenarios. Those performing
Following on from induction/orientation training,
such evaluations should themselves have received
individuals use pre-defined programmes or personal
training to provide assurance that the assessments
training plans to reach competence in the required
performed are consistent, unbiased and directed
activities, skills and tasks which are evaluated at
towards organisational needs, company culture and
the next process-defined stage review (for example
(where applicable) regulatory requirements. For
during a regular PDR).
example, in certain GxP environments, staff must
hold specific qualifications, education and experience
to hold named regulatory responsible positions. 4.6 Analysis of individual training
and competency needs
4.4 Competency levels at employment Once the training and competency programme
At the point of employment, an employee should be has been defined, each individuals needs can
reviewed against the recommended competencies be analysed through an assessment of the
for that job role. These competencies will be taken existing qualifications, knowledge, skills and
from an overview of the company and individual experience against those required to fulfil the roles,
objectives. For staff with prior relevant experience, responsibilities and tasks assigned.
and/or transferable skills, early evaluation by line The mechanism of assessment may be formal or
management, SMEs, trainers and/or a mentor, can informal, however, in either case, the outcome should
potentially result in a documented evaluation which be documented with planned remediation for any
may negate or reduce the need to complete the shortfalls or gaps identified. Remediation activities
necessary/full induction training programme. For should be discussed and agreed between the
example, staff working in a similar role moving from individual, their line manager and (where applicable)
one organisation to another may require only pointing discussed with the trainer and/or mentor. Commonly,
towards the necessary information sources and/or individual training and development plans arise for
familiarisation with in-house systems and standards, the short term (up to 12 months), medium term (up to
rather than training from the basic level needed by a 3 years) and long term (up to 5 years and beyond) and
novice employee. would include a combination of mandatory, role-based
When SMEs with pre-existing knowledge, experience and needs-directed training. These activities usually
and technical skills are recruited to an organisation, take place during periodic PDRs/appraisals.
mechanisms should be in place to verify and Loss of competency due to periods of inactivity in
acknowledge that experience. For example, a role or task (planned or unplanned, such as in the
management or GxP-specific attestation can be put event of maternity or paternity leave, pre-retirement
in place such as a competency statement and the or sickness) should be considered during periodic
induction programme be appropriately tailored. reassessments, to ensure staff maintain necessary
competencies or re-train/refresh as necessary.
13
Analysis of group or organisational needs may Managerial and/or peer review on-the-job.
similarly result in strategic training and development Forward planning by the organisation (for example
plans to ensure organisational continuity or to meet future organisational requirements such
organisational development, facilitate succession as expansion into a new therapeutic or technical
planning and enable the workforce to meet future area, change or introduction of legislation or
organisational needs. similar).
4.6.1 Gap analysis The formality and periodicity of the individuals TNA is
an organisational decision. However, where there is a
Review of an individuals training needs can be
specific legislative requirement the assessment may
a cumulative assessment of performance over
be formalised to ensure repeatability, consistency
time but is typically performed at induction and
and quality of the process as well as evidence in the
regularly thereafter (annually as best practice) in
event of audit or inspection.
a GxP environment. This frequency of training
needs, competency and development targets is Evidence which supports the identification of a
recommended in a research environment to ensure training need for an individual or group of individuals
skill sets are maintained and promote innovation. could include:
Methods to assess the training needs of an individual Repeated departures from, or failures against,
include (but are not limited to): documented procedures/processes.
Review of stated education, qualifications, skills Peer, managerial or stakeholder feedback
and experience in curriculum vitae (CV) against following a period of performance monitoring or
the roles, responsibilities and tasks of the job routine interactions.
description or role specification. Gaps in skills or knowledge relative to tasks,
Exemplified descriptions during recruitment assignments or regulations which is identified at
and induction discussions against known interview, on-boarding, induction or thereafter.
circumstances encountered in routine activities Self-inspection, quality control, audit or inspection
and processes. results.
Discussions with line manager, mentors, trainers
or SMEs.
Formal testing, evaluation or examination.
Self-identification by the individual based on
reflection of previous performance or review of
future project and strategic requirements.
Gap analysis
120%
What training needs does the
100% individual have to reach the
required performance?
80%
60%
40%
20%
0%
Required performance Current performance
14
5 Training toolbox
IIunderstand.
hear and I forget. I see and I remember. I do and
(Confucius)
Recognising the distinction between the process The simplest way to understand an individuals
of training and the experience of learning is vital learning style is to be open and ask the individuals
to effective workplace education. Training is the themselves, either before or during the training. Prior
process the instructor uses, whereas learning is the to the training event you can conduct interviews or
experience the learner has and results in the desired surveys to ask participants specific questions that help
change. Without learning, training is purely going you tailor the training event. Another way would be to
through the motions. conduct pre-training assessment, knowledge or skill
checks to assess the baseline points of individuals.
Before conducting a training event, consideration
should be given to the following points which should The most important criterion for effective delivery
be described in the outline or description of any piece of the training material is that it should enable
of training: participants to achieve the learning outcomes. We
need to be aware that different participants learn
Learning/training objectives and outcomes
differently and that they have different backgrounds
what is the purpose of the training and what
and baseline skills and knowledge. The 70:20:10
demonstrable outcomes are expected once the
Model for Learning and Development is a commonly
training is completed, including mechanisms for
used formula within the training profession to
effectiveness checks? Training objectives and
describe the optimal sources of learning. It holds that
outcomes need to be clearly defined for each
individuals obtain 70 per cent of their knowledge from
piece of training so as to ensure management,
job-related experiences, 20 per cent from interactions
trainees, trainers and others involved in training
with others, and 10 per cent from formal educational
are thoroughly informed of the aims of the
events. (Lombardo and Eichinger, 2006).
training. Objectives must indicate what will be
different as the result of the training and how we The models creators suggest that hands-on
will know that we have achieved the objectives experience (70 per cent) is the most beneficial for
taking account of skills, knowledge, attitude and employees because it enables them to discover and
behaviours. refine their job-related skills, make decisions, address
Prerequisites what background knowledge and challenges and interact within work settings. They
skills is the trainee required to have. also learn from their mistakes and receive immediate
feedback on their performance.
Mode of delivery for example face-to-face,
e-learning, a blend of different training methods. Employees learn from others (20 per cent) through a
Regulatory requirements and expectations. variety of activities that include coaching, mentoring,
collaborative learning and other methods of
Availability and quality of training materials.
interaction with peers. Encouragement and feedback
Budget constraints. are prime benefits of this valuable learning approach.
Time constraints.
Only 10 per cent of professional development
Linked qualifications or certifications. optimally comes from formal traditional course
Mode of assessment, if any. instruction and other educational events.
From an individuals perspective, consideration
should be given to the following:
Personal goals and ambitions what makes the
person tick or what might motivate them to learn.
Previous experience both subject knowledge and
skills and emotional barriers to learning that might
help or hinder the learning experience.
Time constraints that might affect the time an
individual can spend in training; consider both
duration and session timing.
15
Learning styles (Rogers, 2001, p.24)
Learning Stage
style associated with Likes Dislikes
Activist Having an Doing and experiencing. Games, Sitting around for too long; working
experience practical activities, anything that alone; theorising; having to listen to
is energetic and involving. others.
Reflector Reviewing the Time to think, observe, take it Being thrown into activity, no time to
experience all in; watching others; solitude think; crammed timetables; lack of
and time. privacy, no time to prepare.
Theorist Concluding from To know where something fits Frivolity, mindless fun; wasting time; not
the experience into overall ideas and concepts; being able to question; lack of a timetable
analysis and logic; being and structure.
stretched; abstract concepts;
structure, clarity.
Pragmatist Planning the next Practical problem solving; Anything theoretical; learning that
steps relevance to the real world; focuses too much on past or future and
applying learning. not present.
16
5.3 Computer-based training trainings are highly effective and give hands-
on experience without the risk of actual task
5.3.1 E-learning performance. For example, flight simulators have
E-learning is an alternative to face-to-face training been used successfully for years to train airline and
that has become increasingly popular in recent times military pilots in critical flying skills. Simulations
as it offers a number of advantages. For example, are designed to mimic the processes, events, and
e-learning is consistent in the manner in which it circumstances that are relevant to the trainees role.
is delivered. It has the ability to reduce trainees 5.3.3 Webcasts/webinars/teleconferences
learning time, by allowing trainees to learn and
progress at their own pace and produce cost savings: A webcast is a video broadcast of an event
travel to training venues is not required and training transmitted across the internet (Oxford Dictionaries,
materials are reduced. 2015). The term webinar has also been commonly
used to mean seminars or media presentations or
E-learning is particularly difficult to get right. It needs events containing audio and visual components which
to be interactive and engaging and it is important to offer interactivity to participants for example Q&As at
recognise how the human brain and memory work appropriate intervals can be included in the session
(the brains ability to remember increases when (Williams, 2012). Teleconferences can also be used
we hear and see something together i.e. similar instead of/in addition to the Internet to share audio
to watching a movie or going to an exhibition). material.
Repeating the behaviour reinforces learning which
increases memory retention. Internet-based meetings, presentations, seminars
and other similar types of events continue to grow
E-learning is effective at developing procedural in popularity due to their accessibility and flexibility
knowledge and knowledge of defined regulations and relatively low costs as compared to face-to-face
and guidelines. It can also do an excellent job of events. Also, they offer the possibility to record the
describing when and how to apply knowledge to event for future access (e.g. by colleagues who
various situations. This is achieved through repeated were unable to attend the original event), interactive
presentation of facts, using a variety of formats and elements, instant questions and feedback.
presentation styles. The e-learning training delivery
method is particularly valuable in documenting training
completion and training effectiveness assessment, 5.4 Self-learning
if required. The latter can be achieved by linking Through self-learning, the individual acquires
specific knowledge testing tools to pieces of learning. relevant knowledge guided by structured materials,
Additionally, the evaluation of training (i.e. how the ranging from print to electronic systems. Training
trainees perceived it) can also be linked to the training programmes tend to include an element of self-
module and data easily obtained in a timely manner. directed learning in their overall design and delivery,
E-learning allows organisations to give their allowing individuals the freedom and flexibility to
employees easy access to learning materials on the learn on their own terms.
companys intranet or on a training vendors website. This type of learning complements and reinforces
There are many courses available in many different other, more formal or interactive training activities,
areas which provide an interactive way for individuals increasing retention of the learned material. It can be
to work through the required training materials. performed continuously, as an integral part of
Furthermore, training materials are standardised so all day-to-day work activity, and places the responsibility
trainees are provided with the same level of detail. on the individual in planning their personal
One possible disadvantage of e-learning is that there development. Self-discipline is required for self-
is often little opportunity for human interaction, to learning and some training or specific support of, for
discuss the material and any resultant questions with example trainers, management or coaches, may be
others or to monitor how the trainee is performing. required in this area.
However, this is changing and tools such as wikis,
blogs and discussion boards can be used to aid 5.5 The future of training delivery?
ongoing communication. The above paragraphs contain some example training
methodologies currently seen in use throughout the
5.3.2 Simulator/video training
industry. It is important that organisations monitor
Simulator and video training can also be a particularly the latest training trends and technological advances
powerful way to train individuals in a protected and adapt their training strategies accordingly, and in
environment that is using three-dimensional and a timely manner, so as to ensure that the methods
interactive technology to simulate virtual reality remain relevant and up to date. Furthermore, it is
and immersing the trainee in a learning situation important to learn from other regulated industries and
while gaining relevant experience. These simulation cross-pollinate as much as possible.
17
6 Training assessment and evaluation of
training and competency programmes
Examples of KPIs are: When there are any changes such as changes to
organisational structure, legislation, internal standards
Improved performance versus budget or
or computer systems, an evaluation of the training,
reduced costs
and/or training and competency programmes, needs
Reduced error rates or rework to take place to assess the impact of the change on
Enhanced skill levels the training needs and to recommend a plan of action
% individuals on training programmes versus to ensure that organisational objectives can continue
optimal numbers of delegates to be met.
Participant feedback scores immediately after a
training event
% individuals behind in meeting training plans
Training assessment scores
Course pass rate first time
Individual training course cancellations.
18
6.2 Evaluation and assessment at 6.2.3 Assessment
individual level training plan and There are many different methodologies for skills and
trainee knowledge assessment. Additionally, an assessment
of attitudes and behaviours is an important aspect.
6.2.1 Training plan evaluation
The appropriate assessment type is dependent on a
Evaluation of training plans will ascertain if training number of factors such as the criticality of the activity
materials, approach, development and delivery will or task being trained, or the training delivery media
produce the desired outcome. Timely evaluation and resources. Here is a selection of methodologies
provides the opportunity to modify and enhance with an explanation of those most commonly used:
the training and can identify and mitigate individual
learning gaps. Observational assessment: An experienced, trained
and competent assessor will observe the trainee
Resource constraints may not permit evaluation carrying out a task.
of all training so many organisations adopt a risk-
based approach to identify those training courses for An example of on-the-job training and assessment
which effectiveness evaluations are required. Those is auditor training in the conduct of investigational
activities critical to the organisation, such as adverse site audits in the clinical research setting. An
event safety reporting in the pharmaceutical industry, auditor in training will accompany an experienced
are typically subject to such evaluation. auditor or designated trainer to observe and then
progressively assist in audit activities until they
Evaluation can take the form of trainee perception of are at a point where they will be observed by an
training or an assessment of how much trainees have experienced auditor-assessor. If deemed to be
learned in terms of acquiring knowledge and skills as competent to conduct an audit independently,
an output from the training programme. there is then typically a sign-off process. A similar
process is often followed for monitors in clinical
6.2.2 Trainee perception evaluation
research.
Trainee perception evaluation normally involves the
Multiple choice questions or quizzes (paper-based
completion of a survey or questionnaire, paper-based
or electronic): These questions with a number
or electronic. Best results are obtained if the survey
of answer options are commonly administered
is administered immediately after the training delivery
at the end of process-based training where key
to score attributes such as content, mode of delivery,
knowledge areas are assessed. The aim of these
materials and, if applicable, trainers and facilities. The
questions is to determine that a minimal degree of
aim of these scores and feedback is to determine if
mastery and/or understanding has been achieved.
the training met the expectations of the participants
These are popular as they are easy to assess,
and gave them the knowledge and skills they require
particularly if the process is automated through an
and the confidence to apply the newly acquired skills
e-learning module. A pass mark will be set (usually
in the workplace.
at 80% or higher) and this must be achieved to
Additionally, the survey can be used to ascertain receive a credit for completion of training. For
information on any barriers to using the new example, for computer user training, system
knowledge and skills. It is advised that review and access may be contingent on achieving the pass
debrief of the perception data takes place early mark or higher to gain system access. Limits on
after the training programme so that any necessary retakes may be put in place after which the training
improvements to design, materials and delivery would have to be retaken.
can be made. Periodic review can then take place
Written examinations: Examinations can be
thereafter to ensure continuous improvement and
administered for those knowledge-based training
continued relevance.
courses where a comprehensive understanding
and knowledge base is required for example
therapeutic area training or training on legislation or
guidelines.
Other methodologies: Self-paced simulations, oral
questioning, project assignments, aptitude testing
and assessment centres.
19
Appendix 1
Main regulatory requirements/guidelines
The table below contains examples of the main regulatory requirements and guidelines
pertinent to the training of staff.
Good
The Organisation for Economic Co-operation and Development (OECD) Principles of GLP and
Laboratory compliance monitoring (ENV/MC/CHEM (98)17) states that test facility management has a
Practices (GLP) responsibility to ensure sufficient number of qualified personnel. Study personnels responsibility
is to be knowledgeable in those parts of the principles of GLP applicable to their involvement in
the study.
FDAs Title 21 CFR Part 58 states that each individual engaged in the conduct of or responsible
US
for the supervision of a nonclinical laboratory study shall have education, training, and experience,
or combination thereof, to enable that individual to perform the assigned functions. Each testing
facility shall maintain a current summary of training and experience and job description for each
individual engaged in or supervising the conduct of a nonclinical laboratory study.
OECD ENV/MC/CHEM (98)17: http://www.oecd.org/officialdocuments/
publicdisplaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en
US 21 CFR Part 58: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.
cfm?CFRPart=58
Good EU Commission Directive 2003/94/EC states that the personnel shall receive initial and ongoing
Manufacturing training, the effectiveness of which shall be verified, covering in particular the theory and
Practices application of the concept of quality assurance and good manufacturing practice, and, where
appropriate, the particular requirements for the manufacture of investigational medicinal products.
FDAs Title 21 CFR Part 211 states that each person engaged in the manufacture, processing,
US
packing, or holding of a drug product shall have education, training, and experience, or any
combination thereof, to enable that person to perform the assigned functions. Training shall
be in the particular operations that the employee performs and in current good manufacturing
practice (including the current good manufacturing practice regulations in this chapter and written
procedures required by these regulations) as they relate to the employees functions.
Commission Directive 2003/94/EC: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/
dir_2003_94_en.pdf
US 21 CFR Part 211.25: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=211
International ISO based QMSs (e.g. 17025:2012) specify the training and competency of staff; training shall
Organisation for be the responsibility of management and will be relevant to the present and anticipated tasks of
standardisation individuals. The effectiveness of the training actions taken shall be evaluated.
(ISO) based
ISO 9001:2015 requires the determination of competence in the form of knowledge, training and
QMSs experience. Then, as necessary, for organisations to acquire the competence and evaluate the
effectiveness of the actions taken.
20
Good GVP I. C.1.2. mandates that the applicant or marketing authorisation holder should provide
Pharmacovigilance the Qualified Person Responsible for Pharmacovigilance (QPPV) with training in relation to its
Practices (GVP) pharmacovigilance system, which is appropriate for the role prior to the QPPV taking up the position
and which is appropriately documented. In addition Module I.B.7 states all personnel involved in the
performance of pharmacovigilance activities shall receive initial and continued training. Additionally
there are specific modules on the specific training of auditors (GVP IV.B.3.1.2)
and staff members related to Periodic Safety Update Reports (PSURs) (GVP VII.B.7).
GVP Modules: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_
listing/document_listing_000345.jsp
Computer US FDAs Title 21 CFR Part 11 states in part A that FDA will determine that persons who develop,
Systems maintain, or use electronic systems have the education, training, and experience to perform their
Validation assigned tasks.
Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme (PIC/S)
section X states that the regulated user is responsible for ensuring all staff who have to perform
tasks in connection with computerised systems are given the requisite training and relevant
guidelines on computerised systems.
PIC/S Good Practices for Computerised Systems in Regulated GXP Environments:
http://www.picscheme.org/pdf/27_pi-011-3-recommendation-on-computerised-systems.pdf
US 21 CFR Part 11: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
US General Principles of Software Validation: http://www.fda.gov/RegulatoryInformation/
Guidances/ucm085281.htm
OECD GLP Guideline for the Validation of Computerized System (Draft):
http://www.oecd.org/chemicalsafety/testing/Draft-OECD-GLP-Guidance-Document-
computerised-systems.pdf
Good
Personnel engaged in epidemiologic research and related activities should have the education,
Epidemiological training, or experience necessary to perform the assigned functions competently. The organisation
Practices should maintain a current summary of training and experience of these personnel.
International Society for Pharmacoepidemiology: http://www.pharmacoepi.org/resources/
guidelines_08027.cfm#2
Good Commission Guideline 2013/C 343/01 on GDP of medicinal products for human use states
EU
Distribution that all personnel involved in wholesale distribution activities should be trained on the
Practices (GDP) requirements of GDP. They should have the appropriate competence and experience prior to
commencing their tasks. Personnel should receive initial and continuing training relevant to
their role, based on written procedures and in accordance with a written training programme.
The responsible person should also maintain their competence in GDP through regular training.
In addition, training should include aspects of product identification and avoidance of falsified
medicines entering the supply chain.
Commission Guideline 2013/C 343/01: http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:C:2013:343:0001:0014:EN:PDF
Trials of ISO 14155:2011(E) Clinical investigation of medical devices for human subjects Good Clinical
Devices Practice states that prior to commencement of the clinical investigation, the sponsor shall
ensure documentation of training, experience and scientific or clinical knowledge for all the
relevant parties involved in order to adequately conduct the clinical investigation. Clinical
Investigation Planning states that all parties participating in the conduct of the clinical investigation
shall be qualified by education, training or experience to perform their tasks and this shall be
documented appropriately.
Good Clinical Veterinary ICH Good Clinical Practice (ENV/MC/CHEM (98)17) states that each individual involved
Practice in conducting a clinical study should be qualified by education, training, and expertise to perform
(Veterinary) their respective task(s).
Veterinary ICH ENV/MC/CHEM (98)17: http://www.ema.europa.eu/docs/en_GB/document_
library/Scientific_guideline/2009/10/WC500004343.pdf
21
Appendix 2
Trainers toolbox
22
Lose control Dont restrict yourself to the same method, or picking
just one method, consider using blended learning
The question of who should be in control of the where you incorporate different learning methods
learning experience and what elements of the training within the same event to allow a learner to learn,
we should control is often a hard one for regulatory for example using an e-learning to introduce the
trainers to grasp. We are programmed to think knowledge, followed by an interactive workshop
control equals quality, so if we want quality learning to apply the skill and finally a workplace assessment
surely we need to control the learning experience. to demonstrate the application of the skill and
The answer to the control question is actually quite knowledge. Remember different learners might
simple. We should control the output of the learning prefer different types of delivery methods.
experience, but the input and the mechanism to get
to that output should be controlled by the needs Hold the trainee accountable for their own
of the individual as far as practically possible. There learning
must be a clear end result of the learning, something
that is achievable; a skill, knowledge or attitude an Throughout this appendix we have talked about how
individual changes as a result of going through the the learner is the one that must have the experience
experience; consider these as the learning objective. to deliver the intended results, so the final tips should
There must also be a clearly defined control come as no surprise. The trainee must be an active
mechanism to measure that the end result has been participant in their learning experience so they must
achieved; consider this the assessment or evaluation also be accountable for that learning, rather than
to prove the learning objectives were achieved. being a passive observer.
Accountability is important in a regulated
Choose your delivery carefully environment. Accountability and integrity is necessary
for the completion of tasks and duties so why should
For many, the view of a training session is a lecture
training or learning in the regulated environment be
style presentation, where the trainer talks through a
any different? Individuals must own their learning
slide deck covering all the important information the
experience and they must be accountable for the
trainee MUST learn. We gain this view through our
completion of their learning journey. Accountability in
personal experiences of education, whether it be a
training can come in many ways:
school classroom or a university/college lecture hall.
However, ask yourself if a lecture is a good way to Self-assessments are a great way to allow
learn and why did we have to spend so much time individuals to be accountable for their learning. You
revising before exams? If the lectures gave us all we can use self-assessment throughout the learning
needed to learn why did we have assignments and event, to identify their starting position, their
assessments to complete? The answer is, a lecture is progress along and finally once theyve reached
only part of the experience, its the introduction to the the end of their learning journey.
topic, its not the end its only the start of the journey.
Other ways of empowering accountability include:
When choosing the delivery method for your training, self-directed learning and identification of next
it is always important to consider what the trainees steps to continue their learning. This usually
will do and how they will participate in the training occurs through a development scheme, or having
event. What activities are there going to be or a robust career progression map.
exercises for the trainees to do, questions to answer,
discussions with peers, assignments or case studies
to complete? Always build in active participation
rather than passive observation for the audience to
allow the learner to experience. It is also important
to take into account the intended end result of the
learning, for example do you need the trainee to
understand knowledge or apply a skill?
23
Appendix 3 Example templates
CV template
Curriculum Vitae
Employment History
Current Position
Job Title Company Name, Short Address, Country Start Date: Ongoing
Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks
Previous Positions
Job Title DD Mon YYDD Mon YY
Include previous positions held with this employer.
Responsibilities
Summary of tasks
For similar roles summary of tasks may reference to current position noting increasing responsibility over
time. For different roles, full details may be provided to give an overview of the breadth of experience.
Job Title Company Name, Short Address, Country DD Mon YYDD Mon YY
Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks
Job Title Company Name, Short Address, Country DD Mon YYDD Mon YY
Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks
For GxP positions remember to reflect evidence of experience, qualifications, and skills gained to support an
assessment you are suitably qualified and competent. Include for example specific training in regulations/
guidance, critical processes etc. from previous employers.
Training Courses
[Optional; Recommended for Consultants]
Course Title Provider, Location, Country DD Mon YY DD Mon YY
Course Title Provider, Location, Country DD Mon YY DD Mon YY
Include short summary of courses in the last two years relevant to the position held. Include technical,
regulatory and computerised systems courses or refer to internal training record.
24
Qualifications/Certificates
Qualification Title Type of Qualification Award Date
Qualification Title Short Summary YYYY
Professional Memberships
Membership Details of Institution/Organisation DD Mon YYDD Mon YY
Languages
Language Level (Native Language, Basic, Proficient, Expert)
Publications
Author Name(s), Year, Title of Paper, Title of Journal/Source, Journal Issue Number: Page Numbers
Author Name(s), Year, Title of Paper, Title of Journal/Source, Journal Issue Number: Page Numbers
Points to Consider:
1. Signature of the document electronically or on printed copy for authentication purposes.
2. Periodic review to ensure details are current; common practice is for review each year with performance
review and/or review every two years.
3. The CV should be updated with significant changes/new information for example change in job title/role
and/or employer, new qualification or membership.
25
Job/role description template
Job/role description
Areas of responsibility
A short summary of HOW the job purpose is achieved; for example:
1. Audit of internal and external GxP studies, facilities, systems and processes
2. Audit of third parties working on behalf of <organisation name>
3. Development, maintenance and provision of GxP induction and periodic refresher training
4. Project work (as assigned) to support operational teams in the development of new GxP systems and
processes (within and between functions) ensuring regulatory compliance and organisational needs are met
5. Inspection support (during preparation, conduct and corrective/preventative action, and/or follow-up)
6. Designated Archivist
Tasks
A short summary of HOW the areas of responsibility are met; for example:
1. Comply with organisational policy, procedure and applicable regulations
2. Plan, perform, report GxP and third party audits and archive audit-related records
3. Issue audit certificates and statements (where required by procedure and GxP requirements)
4. Maintain GxP knowledge and contribute to the development of GxP systems/processes (when required)
5. Review and maintain training materials in line with current regulatory hot topics and respond to training
feedback to improve effectiveness and delivery of GxP induction training
6. Respond to questions and queries from functional teams within procedurally specified timelines
7. Co-ordinate or lead inspection support teams to ensure timely delivery of information and responses to
inspection-related regulatory authority requests
8. Host the inspection and communicate inspection progress and results in accordance with SOPs
9. Receive records, perform checks and archive materials as per SOPs
26
Note: Commonly the job/role description will also include minimum standards/expectations for experience,
qualifications, skills and/or personal attributes for the job/role.
Personal specification
A short summary of WHAT attributes an appropriate individual will have to successfully
perform the job/role; for example:
Attribute Required Desirable
Experience: 35 years experience in a GxP environment
Experience: At least 2 years audit experience
Qualifications: A science degree or equivalent
Skills: Good numeracy and [English] language skills
Skills: Familiarity with industry standard computerised system
applications such as Microsoft Word, PowerPoint and Excel
Skills: Good written and verbal communication skills
Personal Attributes: Ability to work and travel alone
Etc.
Signed Date
Signed Date
Note: There is an expectation within GxP systems that it can be determined from records when
management and the individual agreed the roles/responsibilities assigned to them; this is most
commonly via personally signed and dated job/role descriptions (but can be via alternative records).
27
Training/learning record template
Conferences/Symposia/Professional Associations
Summary Short description/location/duration Date(s)
Signed Date
Signed Date
Note: Record maintained in an ongoing manner; printed and signed at periodic intervals in agreement
with Supervisor for example at performance review. Alternative template designs contain a signature for
each entry.
28
Training programme/plan template
Training and competence log template
Training programme/plan
Job/Role Title SOP/Task No.1 No.2 No.3 No.4 No.5 No.6 Task 1 Task 2 Task 3
Role A R&U R&U R&U R&U C C C T
Role B R&U R&U R&U C C C
Role C R&U R&U R&U R&U R&U T
Role D R&U C C C C C C C C
Alternatively:
SOP/Task Job/Role Role V Role W Role X Role Y
No. 1 R&U R&U T
No. 22 R&U R&U C
No. 23 R&U R&U C
No. 24 R&U
No. 55 R&U
No. 237 R&U
Task 1 e.g. Mandatory C C C C
Pharmacovigilance Training (e-Learning)
Task 2 e.g. Mandatory Health & Safety C C C C
Training (face-to-face)
R&U: Read and Understand (R&U) Procedure/Task; generally the minimum training in a procedure
C: Achieve Competency in Procedure/Task; perform the procedure competently unsupervised
T: Develop adequate skills to train others to perform the task competently
Date/Version No.
Competency level
Level A Level B Level C
Skill/procedure trainee* trainer* trainee* trainer* trainee* trainer* Comments**
29
Training record review template
The completeness of the record was verified between the employee and their
line manager on leaving on: DD Mon YYY
Signed Date
Signed Date
30
Appraisal template
Comments:
Explanation/Comment re: partial completion of objective 2
Reviewers comments
Individuals comments
Signed Date
Signed Date
31
Performance development plan template
Signed Date
Signed Date
32
Glossary and definitions
Appraisal is a process for individual employees rganisational objectives are the overall goals,
O
and those concerned with their performance, purpose and mission of an organisation that
typically line managers, to discuss their performance have been established by its management and
and development, as well as the support they communicated to its employees.
need in their role. Its used to both assess recent
ersonnel Development Review is a periodic,
P
performance and focus on future objectives,
structured review of an individuals personal
opportunities and resources needed.
development plan to ascertain if they have met the
ssessment is the measurement of whether a
A plan goals and whether the plan needs to be revised
participant has achieved the desired end result and is based on changes to personal and organisational
competent. goals.
Competency is the ability to do something Quality by design is an approach that aims to ensure
successfully and efficiently to meet the required the quality of medicines by employing statistical,
performance standard. Competencies are therefore analytical and risk-management methodology in
demonstrable knowledge and skills coupled with the the design, development and manufacturing of
right attitude and behaviours. Regardless of training, medicines.
competency will grow through experience and the
Quality Management System is a set of policies,
extent to which an individual learns and adapts
processes and procedures required for planning
through experience.
and execution (production/development/service) in
Education is the experience of gaining knowledge, the core business area of an organisation (i.e. areas
skill or attitude resulting in a change. that can impact the organisations ability to meet
customer requirements). ISO 9001 definition.
Evaluation is the measurement of the success of the
training on achieving the desired learning outcome efresher training is training intended to revise and
R
and objective. update knowledge and skills.
Good practices or GxPs refer to a set of quality raining is an organised activity aimed at imparting
T
standards. Examples include the internationally information and/or instructions to improve the
accepted standards on good manufacturing, good recipients performance or to help him or her attain a
clinical, good documentation, good laboratory, good required level of knowledge or skill.
pharmacovigilance and good distribution practices.
raining and development policy is a high-
T
Induction Programme/Plan is an important process level document which outlines the framework
for bringing staff into an organisation which provides and governance for the training and development
an introduction to the working environment and of individuals and functional groups within an
the set-up of the employee within the organisation. organisation.
This programme is often documented in a plan at an
ersonal Development Plan is an action plan for
P
individual, role or functional level.
an individual which outlines the personal, career and
Learning is the acquisition of knowledge or skills educational goals with corresponding strategies for
through study, experience, or being taught. learning, training and gaining experience to achieve
these goals.
earning/training outcomes/objectives are
L
statements that describe significant and essential
learning that learners have achieved, and can reliably
demonstrate at the end of a course or programme.
33
Abbreviations References
CFR Code of Federal Regulation Cheese, P. (2015). Foreword. In: Beatson, M., and
Zheltoukhova, K. Productivity: Getting the best out of
CV Curriculum Vitae
people. London: Chartered Institute of Personnel and
EU European Union Development.
GCP Good Clinical Practice Business Dictionary. Training. [Online]. [Accessed 21
September 2015]. Available from:
GDP Good Distribution Practice
http://www.businessdictionary.com/definition/training.
GLP Good Laboratory Practice html
GMP Good Manufacturing Practice Honey, P., and Mumford, A. (1982). The Manual of
Learning Styles. London: Peter Honey Publications.
GVP Good Pharmacovigilance Practice
Kirkpatrick, D. (c2009 2015). The Kirkpatrick
GxP Good Practice
Model. [Online]. [Accessed 21 September 2015].
ICH International Conference on Available from:
Harmonisation of Technical Requirements http://www.kirkpatrickpartners.com/OurPhilosophy/
for Registration of Pharmaceuticals for TheKirkpatrickModel
Human Use
Knowles, M.S. (1989). The making of an adult
ISO International Organization for educator: An autobiographical journey. San Francisco,
Standardization CA: Jossey-Bass.
IT Information Technology Kolb, D.A. (1984). Experiential Learning: experience
as the source of learning and development.
KPI Key Performance Indicator New Jersey: Prentice-Hall.
OECD Organisation for Economic Co-operation Lombardo, M.M., and Eichinger, R.W. (2006). The
and Development Career Architect Development Planner. 4th Edition.
PDR Personnel Development Review Minneapolis, MN: Lominger
PIC/S Pharmaceutical Inspection Convention Rail Safety and Standards Board Limited, (2013).
Pharmaceutical Inspection Co-operation Good practice guide on competence development.
Scheme [Online]. London: Rail Safety and Standards Board
Limited. [Accessed 21 September 2015].
Q&As Questions and Answers Available from:
QMS Quality Management System http://www.rssb.co.uk/improving-industry-
performance/human-factors/human-factors-case-
QPPV Qualified Person Responsible for studies/good-practice-guide-on-competence-
Pharmacovigilance development
PSUR Periodic Safety Update Report Rogers, J. (2001). Adults Learning. 4th edition.
ROI Return on Investment Maidenhead: Open University Press.
34
Further information and additional reading
Quality by Design:
EMA Quality by Design information:
http://www.ema.europa.eu/ema/index.
jsp?curl=pages/regulation/document_listing/
document_listing_000162.jsp
Pharmaceutical Quality for the 21st Century
A Risk-Based Approach Progress Report:
http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
ucm128080.htm
ICH Quality Guidelines:
http://www.ich.org/products/guidelines/quality/
article/quality-guidelines.html
ompetency and Training Management:
C
http://www.risktec.co.uk/media/47873/
competency%20and%20training%20
management%20guidelines%203.1pdf.pdf
Training needs analysis:
http://www.cipd.co.uk/toolclicks/learning/training-tools/
training-needs-analysis/default.aspx
Self learning:
http://www.open.ac.uk/choose/unison/develop/my-
skills/self-reflection
he Role of Mentor/Coach/Buddy:
T
http://www.open.ac.uk/about/main/strategy/teaching-
learning-ou
The Training and Development Life-Cycle:
https://cdns3.trainingindustry.com/media/18044506/
training_throughout_the_employee_lifecycle.pdf
E-Learning:
http://www.cipd.co.uk/hr-resources/factsheets/
e-learning.aspx
General learning resources:
http://www.cipd.co.uk/
35
Notes
36
Face-to-Face eLearning
courses courses
Our Courses offer the finest standard of training A range of interactive, online, eLearning courses
and knowledge sharing and have developed which provide an awareness of legislation, current
in response to the requirements of industry. best practice and identify key areas of learning.
Course tutors are drawn from industry and All our courses include a SCORM compliant
Government; have wide experience of current assessment, and certification upon successful
international standards and best practice, completion. Courses are accessible on
and also the practical application of Desktop and Mobile devices.
these within the workplace.
01
02
05 Learning
Options
03
Forums
and
Publications 04 Seminars
The RQA produces a range Seminars and Forums
of booklets providing cover and individual topic
guidance on best practice from a specific area with
and information on varied hand picked speakers from
topics. All these booklets industry and Government.
are available in print, and Regional Forums are held
as an eBook. in a geographical area
to enable attendees
to share knowledge
November 2015
ISBN 978-1-904610-36-6