378 Organisation courses in Royston, South Yorkshire

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 EU Trials Directive, relevant regulations, 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: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) 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: Lively discussions to foster ideas 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 Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd 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 Face-to-face course 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. Remote course 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. CPD Points 14 Points Development Level Develop

This workshop will provide an opportunity to understand and apply a range of commercial analysis tools in a problem-solving environment.

About this Training Course Process Hazard Assessment using the HAZOP Technique is an intensely participative course that will both explain the key facets of the HAZOP technique as well as provide ample opportunities for participants to practice and become familiar with the technique using generic and real-life examples. HAZOP Team Leader Training is an intensely participative course that will develop participants already familiar with the HAZOP technique, the skills, knowledge and attributes of a HAZOP Team Leader. An in-depth syndicate exercise will provide the opportunity to lead a HAZOP team (consisting of other participants) and to be observed performing the role for constructive feedback. This 5 full-day course has been reviewed and approved by the Institution of Chemical Engineers (IChemE). IChemE is the global professional membership organisation for chemical, biochemical and process engineers and other professionals involved in the chemical, process and bioprocess industries. Their knowledge of professional standards, close involvement with industry, education and regulators, and their expertise as a leading global training provider, means they are uniquely positioned to independently assess and approve training courses and professional development programmes across the world. Training Objectives Process Hazard Assessment using the HAZOP Technique By the end of this course, participants will be able to: Understand the basic HAZOP Technique Fulfill roles as competent HAZOP Team Members Understand the role of HAZOP in risk management Understand how Hazard Identification can predict accidents and incidents Understand how HAZOP complements other hazard identification tool HAZOP Team Leader Training By the end of this course, participants will be able to: Understand the role of the HAZOP Team Leader Practise the role in a classroom environment Provide feedback to participants on their performance as HAZOP Team Leaders Appreciate the leadership skills required as HAZOP Team Leader Plan, organise, manage and successfully undertake a Hazard and Operability study Target Audience This course will benefit: All key persons in the organisation, who by their discipline and/or position, are likely to be called on to initiate, participate or review a HAZOP study. All who have responsibility for the management and supervision of process & safety including but not limited to Senior Management, Plant Managers, Process and Maintenance Engineers (all disciplines), Line Supervisors, Team Leaders, Safety Specialists, and Process Training Instructors. Course Level Basic or Foundation Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations

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