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Quality Systems for Research Laboratories

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Course Information

Course Information

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 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 that 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.

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 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.

The benefits of the course

Delegates get immediate access to highly experienced tutors (both former senior scientists), who will share their wisdom and insights in an area where few others have been successful. The course will be linked with the new RQA guidance which builds on years of experience and forms the foundation of the programme.

Course content

Delegates will be guided thoughtfully through each key component of the process in a stimulating learning environment, crafted to deliver clarity from the onset. 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 in detail 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’.

Course design

The course is designed for all those involved in the research quality arena and it has been tailored to meet the needs of scientific management, bench scientists and quality professionals alike.

Course Tutors

Tutors will be comprised from the list below:

Louise Handy
Director, Handy Consulting Ltd (Course Principal)

Sandrine Bongiovanni
Senior QA Fellow in Non-Regulated Quality Systems, Novartis Pharma AG

Recent Feedback

"Thanks for your presentation illustrated with lot of real cases and examples."

CPD Points

14 Points

Course Programme

Please note timings may be subject to alteration

 

Day 1 

 9.00 Registration 
 9.15 Welcome and Introductions 
 9.30 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. 
 10.15 The Culture, the Politics and the Scientist's Perspective
Understanding research environments, the drivers and the challenges. 
10.45 Break 
 11.00 Workshop - Risk Management 
Thinking about risk management and prioritisation.  Looking at the critical factors for the implementations of a successful quality system. 
 12.30 Workshop - Feedback 
 13.00 Lunch 
 14.00 Implementation and its Challenges
Implementing quality systems without stifling the creative environment.  Management support, approaches for implementation and steps to take.
 14.45 Training
Getting it right first time.  Importance of understanding why. 
 15.15 Break 
 15.30 Personnel, Plans and Procedures
Looking at planning the work and defining procedures in a way which promotes robust science without compromising brilliance.
16.15 Research Outsourcing
The challenges of managing the quality of outsourced work.
 16.45 Questions and Answers 
 17.00 Close of day 
 

Day 2 

 9.00 Facilities, Equipment, Materials and Reagents
Ensuring that all these elements are demonstrably fit for their intended purpose.
 9.45 Assay Validation
How much validation is required at what stage?  What do we need to do to validate an assay? 
10.15 Break 
 10.30 Research, Work Records and Archives
Data and records which are accurate, attributable, legally attestable and safe to permit reconstruction of experiments and studies.
11.15 Workshop - Computerised Systems
Exploring how to ensure your systems are fit for purpose, and that data remains accurate, attributable and secure from generation onwards. 
12.00 Workshop - Feedback 
 12.30 Lunch 
 13.15 Research Review
Looking at aspects of the work where there is a chance to review, correct or improve the science, the data and the processes. 
 14.00 Continual Improvement and Quality Systems
Reviewing implementation of a quality system, finding opportunities for improvement, understanding cultural change.
 14.45 Questions and Answers 
 15.00 Close of course 

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

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

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Bed and Breakfast is £77*, dinner is £35*  (* per night per person) - these can be selected during the booking process.

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Recommended Products

Booklets

Guidelines for Quality in Non-Regulated Scientific Research*
Management of the Training and Competency of Personnel in GxP and Research Environments
Quality in Research

Webcasts

Webcast - Quality Systems

eLearning Products

Introduction to Quality Risk Management (QRM) elearning
Introduction to Risk Based Quality Systems (RBQS) elearning
Quality Systems elearning

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