COURSE INFORMATION
This highly interactive course will provide guidance on why and how to implement
a quality system successfully into the research laboratory. By doing so, you
will position your innovation for the success it deserves. But leave things as
they are and there is a good chance that your science will not realise its full
potential should success, and its consequences, come your way.
A quality system in your research laboratory is the most effective and efficient
way to:
* Help scientists work more efficiently
* Ensure discoveries can be defended
* Protect the value of intellectual property.
This course is particularly aimed at those working in early phase research
environments which are not constrained by the regulatory requirements of the
Good Practice regulations but are producing intellectual property, testing
and/or products for the therapeutic market. For organisational reasons, rather
than regulatory ones, this is a place where you need to get it right.
The programme is delivered by leaders in the field who, quite simply, ‘have done
it’. Whether delegates are at senior management level seeking strategic
direction, a laboratory head wishing to deliver science that will stand the test
of time or a quality professional thrown in at the deep end, this course will
provide key insight and practical guidance to underpin future success. Based on
risk based systems, tried and tested over many years in the workplace, the
programme will help delegates to define, train, implement and monitor the
quality of their research, irrespective of field or discipline. Delegates will
learn how to help position their organisation for success.
COURSE CONTENT:
Delegates will be guided thoughtfully through each key component of the process
in a stimulating learning environment. The course probes all avenues of the
research quality arena, from an initial understanding of the cultural aspects of
the scientific discovery environment, to managing quality in outsourced research
programmes. Computer systems and e-data security in the research environment
will be discussed and pragmatic solutions described to help manage the
ballooning cloud of e-data. In addition, the ever blurring boundary between the
regulated and non-regulated research environments will be discussed and
delegates given perspective on future developments in the field.
With this knowledge, delegates will be able to get it ‘right first time’.
IS THIS COURSE FOR YOU?
The course is designed for all those involved in the research laboratory quality
arena and it has been tailored to meet the needs of scientific management, bench
scientists and quality professionals alike.
Delegates get immediate access to highly experienced tutors who will share their
wisdom and insights in an area where few others have been successful. The course
is linked with the RQA guidance which builds on years of experience and forms
the foundation of the programme.
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TUTORS
Tutors will be comprised of (click the photos for biographies):
LOUISE HANDY
Director, Handy Consulting Ltd
SANDRINE BONGIOVANNI
Associate Director in Research and Quality Compliance, Novartis
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PROGRAMME
Please note timings may be subject to alteration.
DAY 1
09:00
REGISTRATION
09:10
WELCOME AND INTRODUCTIONS
09:20
HISTORY AND OVERVIEW OF THE FIELD
Examples of business and regulatory risks and the consequences of low quality in
research. A look at the standards and guidelines that exist.
10:00
THE CULTURE, THE POLITICS AND THE SCIENTIST'S PERSPECTIVE
Understanding research environments, the drivers and the challenges.
10:30
BREAK
10:45
WORKSHOP - RISK MANAGEMENT
Thinking about risk management and prioritisation. Looking at the critical
factors for the implementations of a successful quality system.
12:15
WORKSHOP - FEEDBACK
12:45
LUNCH
13:45
PERSONNEL, PLANS, PROCEDURES, FACILITIES, EQUIPMENT, MATERIALS AND REAGENTS
Looking at planning the work, defining procedures in a way which promotes robust
science without compromising brilliance and ensuring that all these elements are
demonstrably fit for their intended purpose.
14:30
WORKSHOP - ASSAY VALIDATION
How much validation is required at what stage? What do we need to validate an
assay?
15:00
WORKSHOP - FEEDBACK
15:15
RESEARCH, WORK RECORDS, ARCHIVES AND RESEARCH REVIEW
Data and records which are accurate, attributable, legally attestable and safe
to permit reconstruction experiments and studies. Looking at aspects of the work
where there is a chance to review, correct or improve the science, the data and
the processes.
16:15
CONTINUAL IMPROVEMENT AND QUALITY SYSTEMS
Reviewing implementation of a quality system, finding opportunities for
improvement, understanding culture change.
16:45
QUESTIONS AND ANSWERS
17:00
CLOSE OF COURSE
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EXTRA INFORMATION
COURSE MATERIAL
This course will be run completely online. You will receive an email with a link
to our online system, which will house your licensed course materials and access
to the remote event.
Please note this course will run in UK timezone.
THE ADVANTAGES OF THIS INCLUDE:
* Ability for delegates to keep material on a mobile device
* Ability to review material at any time pre and post course
* Environmental benefits – less paper being used per course Access to an online
course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
CPD POINTS
7 Points
DEVELOPMENT LEVEL
Develop