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About us
Implementing Good Clinical Laboratory Practice
Course Information
Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical Trials Regulations and related guidance, and leveraging insights from the RQA guidance document on GCLP.
Is this course for you?
This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites.
This course will give you:
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Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP)
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Insight into the seamless integration of GCLP within clinical programmes (GCP)
- Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories
- The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Access to a seasoned panel of speakers with extensive expertise
- A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios.
Engage in:
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Lively discussions to foster ideas
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Problem-solving sessions targeting specific challenges
- Detailed exploration of specific aspects within the realms of GCP and GCLP.
Tutors
Tutors will be comprised of (click the photos for biographies):
Vanessa Grant
Louise Handy
Tim Stiles
Programme
Please note timings may be subject to alteration.
Day 1
08:50
Registration
09:00
Welcome and Introduction
09:20
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
09:00
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
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.
Course Material
Course material will be available 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.
CPD Points
14 Points
Development Level
Develop
Recommended Products
Good Clinical Laboratory Practice (GCLP) eBooklet
Good Clinical Practice Regulatory Authority Inspections eBooklet
Introduction to Good Clinical Practice (GCP) elearning
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to Quality Risk Management (QRM) elearning
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet