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Quality Systems for Research Laboratories

CPD Accredited

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Remote Course

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.

Tutors

Tutors will be comprised of (click the photos for biographies):

Louise Handy

Louise Handy

Director, Handy Consulting Ltd

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Louise Handy

Sandrine Bongiovanni

Sandrine Bongiovanni

Associate Director in Research and Quality Compliance, Novartis

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Sandrine Bongiovanni

After 15 years spent in Research, Sandrine joined the Quality Assurance field in 2012. Today, as Associate Director in Research and Quality Compliance at Novartis, in Basel, Switzerland, she develops, implements, and monitors holistic, risk based, non-GxP quality programs in research laboratories. She leads and support non-GxP, GLP and GcLP audits.


Sandrine is also actively involved in EU-funded projects aiming to enhance Quality Systems, Data Integrity, and Ethics in Research, such as EQIPD and BEYOND.

LinkedIn Profile

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

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

  • Incredible training course.

  • Louise was very knowledgeable and her experience shows. Easy to understand presentation with thought provoking exercises.

  • Sandrine was very helpful in guiding us through the group workshops, identifying additional areas of discussion that we may have missed. Her presentation was easy to follow and helped build confidence in implementing risk based strategies in quality systems.

Book now

Click below for Course dates/fees:

Remote Course
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