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).
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.
Tutors will be comprised from the list below:
Director of Quality Assurance, Envigo (Course Principal)
Regulatory Compliance Consultant, Qualogy Ltd
Director, Handy Consulting Ltd
"Very interesting examples given."
"Very impressive depth of knowledge and experience, clear and easy to follow presentations."
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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.
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.
Please note timings may be subject to alteration
|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||Safety and Ethical Consideration
Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed.
|10.45||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||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.
|12.15||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||Trial Protocols, Analytical Plans
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.
|14.45||Standard Operating Procedures and Analytical Methods
The control, content and authorisation of SOPs and methods and the principles behind the practice
|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|
How should we assess risk and how can we use the process to assist in evaluation audit findings.
|17.00||Close of day|
|9.00||Conduct of the Work and Quality Control
Many of the issues that surround the conduct of sample collection, shipment, storage and analysis are discussed. This will include the quality control of the assay that may be employed and Quality Control checks.
|9.45||Workshop 3 - Conduct of the Work and Quality Control
Practical work conduct and quality control issues are explored.
|10.45||Workshop 3 - Feedback|
|11.15||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.
|12.00||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.
|13.15||Workshop 4 - Data, Records and Reports
Practical problems with data, records and reports are investigated.
|14.00||Workshop 4 - Feedback|
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.
The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed.
This panel session will address any outstanding issues raised by the delegates.
|16.00||Close of day|