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).
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
"The whole course was great – presentations, workshops, Q&A, brilliant!
Tutors are knowledgeable and approachable.
Having an MHRA Inspector to speak is always useful!"
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||Organisation and Personnel Responsibilities Within the Laboratory
The responsibilities of key functions that should exist within a clinical laboratory are discussed.
|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|
|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.
|15.30||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|
|17.00||Close of day|
|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.
|11.15||Workshop 3 - 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.
|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.
|13.45||Workshop 4 - Data, Records and Reports
Practical problems with data, records and reports are investigated.
|14.30||Workshop 4 - Feedback|
|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.
This panel session will address any outstanding issues raised by the delegates.
|16.00||Close of day|