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Implementing Good Clinical Laboratory Practice

 

 

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If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance

Course Information

This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice (GCLP) in laboratories which undertake the analysis of samples from clinical trials. The course will address the current regulatory framework for laboratory work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. The course will also draw on the RQA guidance document on Good Clinical Laboratory Practice (GCLP).

Who should attend?

Laboratory Managers, analysts, investigators, trial co-ordinators, monitors and auditors working in: pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, investigator sites.

Benefits Include

  • Guidance on the interpretation and application of GCLP within the framework of Good Clinical Practice (GCP)
  • Understand how GCLP fits within a clinical (GCP) programme
  • Practical help on how to implement GCLP within a clinical research laboratory
  • An opportunity to update your knowledge of GCLP with the current interpretation of requirements including guidance on clinical laboratories published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Access to an experienced panel of speakers
  • An opportunity to improve your understanding of the GCLP requirements as they are applied in different situations

The course is structured to encourage delegates to

  • Discuss and develop ideas
  • Solve specific problems
  • Examine particular aspects of GCP and GCLP

Course Tutors

Tutors will be comprised from the list below:

Vanessa Grant
(Course Principal)

Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd

Louise Handy
Director, Handy Consulting Ltd

MHRA

Recent Feedback

"With the help of good facilitation by the facilitators, I was able to easily interpret these GCLP guidelines and also translate them into everyday practice which is exactly why I set out for this course."
"Presentation style was interesting and engaging. Feedback was provided in a constructive way. Very approachable. Assistance with exercises given when clarification requested."
"Very good examples. I gained a good understanding of what is still to be improved in our enivronment."

CPD Points

14 Points

Course Programme

Please note timings may be subject to alteration

 

Day 1 
 8.50 Registration 
 9.00 Welcome and Introduction 
 9.20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice
A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial.  The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained.
 10.00 Safety and Ethical Consideration
Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 
 10.40 Break 
 10.55 Organisation and Personnel Responsibilities within GCP and the Laboratory
The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 
11.30 Staff Training and Training Records
Personnel records of training and competency assessments are discussed.
11.45 Laboratory Facilities, Equipment and Materials
Suitable facility design, organisation and operation will be discussed.  The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions.
 12.30 Lunch
 13.15 Workshop 1 - Facilities, Equipment and Responsibilities
Some practical problems with regard to the facilities, equipment and responsibilities are explored. 
13.45 Workshop 1 - Feedback
 14.15 Computer Systems Validation
Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled.  What this means in practice is discussed.
14.45 Trial Protocols, Analytical Plans
During this session we examine the purpose, content, control and change of these important documents. 
 15.30 Break 
 15.45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation
The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 
 16.30 Workshop 2 - Feedback 
 17.00 Close of day
 

 Day 2 
 9.00 Conduct of the Work and Quality Control
Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks.
 10.00  Deviation Management
The expectations around deviations and CAPA are discussed.
10.15 Workshop 3 - Conduct of the Work and Quality Control
Practical work conduct and quality control issues are explored.
 10.45 Break
 11.00 Workshop 3 - Feedback
 11.30 Source Data, Data Integrity, Records and Reports
The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results.
 12.10 Workshop 4 - Data, Records and Reports
Practical problems with data, records and reports are investigated. 
 12.45 Lunch
 13.30 Workshop 4 - Feedback
 14.00 Quality Audit
The requirements for and purpose of Quality Audits are discussed.  The difference between quality audit and quality control are explained along with the role of the Quality Audit staff and their interaction with the Analytical Project Managers, Laboratory Management and study staff.
 14.40 Risk Management
How should we assess risk and how can we use the process to assist in evaluation of audit findings. 
15.15 Break
 15.30 Regulatory Inspection
The conduct of regulatory inspections and current expectations of the inspectors.  Preparation for inspections and conduct during them will be discussed.
 16.00 Panel Session
This panel session will address any outstanding issues raised by the delegates. 
 16.15 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.

You will also receive a copy of our booklet - "Good Clinical Laboratory Practice"

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 additional 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 (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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Recommended Products

Booklets

Good Clinical Laboratory Practice (GCLP)
Good Clinical Practice Regulatory Authority Inspections
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P02 Good Clinical Practice Auditing - Principles and Practice
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP22 Risk Management in Clinical Trials REMOTE LEARNING

eLearning Products

Introduction to Good Clinical Practice (GCP) elearning
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to Quality Risk Management (QRM) elearning

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