Implementing Good Clinical Laboratory Practice
Course Information
This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice (GCP) 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
Director of Quality Assurance, Envigo (Course Principal)
Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd
Louise Handy
Director, Handy Consulting Ltd
MHRA
Recent Feedback
"The whole course was great – presentations, workshops, Q&A, brilliant!
Tutors are knowledgeable and approachable.
Having an MHRA Inspector to speak is always useful!"
CPD Points
14 Points
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)
Accommodation is available at Madingley Hall for the dates of the course. 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.
Course Programme
Please note timings may be subject to alteration
Day 1 |
|
| 8.50 | Registration |
| 9.00 | Welcome and Introduction |
| 9.15 | 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 | Organisation and Personnel Responsibilities Within the Laboratory The responsibilities of key functions that should exist within a clinical laboratory are discussed. |
| 10.30 | Break |
| 10.45 | Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The callibration, 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. |
| 11.30 | Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. |
| 12.15 | Workshop 1 - Feedback |
| 12.45 | Lunch |
| 13.45 | 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 will be discussed. |
| 14.15 | Trial Protocols, Analytical Plans, Standard Operating Procedures and Analytical Methods During this session we examine the purpose, content, control and change of these important documents. The expectations around contracts and agreements will also be discussed. |
| 15.15 | Break |
| 15.30 | Workshop 2 - SOPs, Clinical Protocols, Analytical Plans, Methods and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored. |
| 16.20 | Workshop 2 - Feedback |
| 16.50 | Questions |
| 17.00 | Close of day |
Day 2 |
|
| 9.00 | Method Validation The ways in which analytical methods are developed, documented, validated, followed and changed are reviewed. |
| 9.25 | Conduct of the Work, Safety and Ethical Considerations and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage and analysis are discussed. Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of GCP are discussed. This will include the quality control of the assay that maybe employed and Quality Control checks. |
| 10.30 | Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. |
| 11.00 | Break |
| 11.15 | Workshop 3 - Feedback |
| 11.45 | 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. |
| 12.15 | Source Data, Records and Reports The creation and subsequent management of source data and records, including personnel records of training and competence are discussed, together with the process of reporting analytical results. |
| 13.00 | Lunch |
| 13.45 | Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. |
| 14.30 | Workshop 4 - Feedback |
| 15.00 | Break |
| 15.15 | Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. |
| 15.45 | Panel Session This panel session will address any outstanding issues raised by the delegates. |
| 16.00 | Close of day |
Recommended Products
Booklets
Good Clinical Laboratory Practice Booklet
Good Clinical Practice Regulatory Authority Inspections Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments
Courses
P02 Good Clinical Practice Auditing - Principles and Practice
eLearning Products
Introduction to Good Clinical Practice (GCP) elearning
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to Quality Risk Management (QRM) elearning
