2059 Courses in Huntingdon

This driver CPC course Vehicle Roadworthiness & Load Safety is suitable for LGV drivers only and will cover: Requirements, Walk Around Checks, Legal Requirements, Additional Checks, Safety Equipment, Defect Reporting, Maintenance, Prohibitions, Considerations Before Loading, Overloading, Load Distribution, Load Security, Vehicle Dimensions, Loading Equipment.

COURSE INFORMATION Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. BENEFITS OF THIS COURSE: * Practical help and guidance on the interpretation and application of GLP * An opportunity to update your knowledge of GLP with the current interpretation of requirements * Access to an experienced panel of speakers * Information on how other organisations address GLP issues * An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. THIS COURSE IS STRUCTURED TO ENCOURAGE DELEGATES TO: * Discuss and develop ideas * Solve specific problems * Examine particular aspects of GLP * Learn from the experience of others. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): TIM STILES Consultant, Qualogy Ltd TONY WOODALL Head of Quality Assurance, Alderley Analytical GILL ARMOUR Study Monitor Team Leader, AstraZeneca JANE ELLISTON Senior Quality Assurance Auditor, Battelle UK VANESSA GRANT -, - JEANET LOGSTED CEO, Scantox -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 09:00 REGISTRATION 09:15 WELCOME AND INTRODUCTIONS 09:35 DEVELOPMENT OF GOOD LABORATORY PRACTICE A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 ROLES AND RESPONSIBILITIES The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 BREAK 11:00 THE ROLES AND RESPONSIBILITIES OF THE STUDY DIRECTOR AND TEST FACILITY MANAGEMENT The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 MULTI-SITE STUDIES What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 STUDY PLAN (PROTOCOLS) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 LUNCH 13:45 WORKSHOP 1 - THE STUDY PLAN Some practical problems with study plans and amendments explored. 14:45 WORKSHOP 1 - FEEDBACK 15:00 STANDARD OPERATING PROCEDURES The control, content and authorisation of SOPs and the principles behind the practice. 15:30 BREAK 15:45 WORKSHOP 2 - PRACTICAL STUDY CONDUCT PROBLEMS Dealing with practical problems encountered during the conduct of studies. 16:40 WORKSHOP 2 - FEEDBACK 17:15 CLOSE OF DAY DAY 2 09:00 QUESTIONS AND ANSWERS Discussion of issues raised by course delegates. 09:20 QUALITY ASSURANCE The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 THE FINAL REPORT The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 BREAK 10:45 WORKSHOP 3 - FINAL REPORT PROBLEMS Practical problems of report preparation including compliance statements. 11:30 WORKSHOP 3 - FEEDBACK 12:00 MANAGEMENT OF RAW DATA AND RECORDS A view on how records and materials are managed and archived in compliance with GLP. 12:45 LUNCH 13:30 WORKSHOP 4 - DATA AND SAMPLE MANAGEMENT ISSUES Dealing with data and sample management issues. 14:15 WORKSHOP 4 - FEEDBACK 14:45 REGULATORY INSPECTION Government monitoring for compliance with Good Laboratory Practice. 15:15 PANEL SESSION This panel session will address any outstanding issues raised by delegates. 15:45 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

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

The Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) is usually a one-year pre-university qualification that provides students with an entry route to an overseas university. The L3IFDHES prepares students with the essential English language skills, key transferable study skills, cultural knowledge, and chosen specialisms that universities feel bridges the gap between high school and undergraduate study. In January 2023 we offer pathways in business and higher finance. With agreements in place with over 70 universities across the globe, students’ can progress with confidence to a higher education course for further study. Entry Requirements For entry onto the NCC Education Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) qualification students must have successfully completed secondary school education. Students must also meet the English language entry requirements of: • IELTS minimum score of 4.5 or above OR • GCE ‘O’ Level English D7 or above Alternatively, a student can take the free NCC Education Higher English Placement Test which is administered by our Accredited Partner Centre’s.

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In-house training courses on electric and hydrogen vehicle technologies, charging infrastructure and how they work.

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