7 Investigator courses in London

This course is suitable for investigators who are investigating a wide range of disciplinary issues plus allegations of bullying harassment and discrimination which, if upheld, may result in a formal warning or dismissal. Delegates who successfully complete this course are able to refer themselves as a TCM Accredited Investigator.

COURSE INFORMATION Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. HOW IS THIS COURSE RUN? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. WHAT WILL I LEARN? * A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments * Solid grounding in quality assurance activities aligned with regulatory standards * Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues * Clarity on the roles and responsibilities inherent to clinical trials auditing * Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents * A nuanced understanding of regulatory inspectors' activities * Expanded professional networks to propel your auditing career forward. BENEFITS INCLUDE: * A clear understanding of the role of the auditor under Good Clinical Practice improved audits * Improved Good Clinical Practice compliance for your clinical trials. THIS COURSE IS STRUCTURED TO ENCOURAGE DELEGATES TO: * Discuss and develop ideas * Solve specific problems * Examine particular aspects of Good Clinical Practice. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): ROSEMARIE CORRIGAN EVP Global Quality, Worldwide Clinical Trials CATHY DOVE Director and Owner, Dove Quality Solutions JULIE KELLY Associate Director, Clinical Quality Assurance, Corcept Therapeutics SUSANA TAVARES Director of Research Quality Assurance, - -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 12:30 REGISTRATION 13:00 WELCOME AND OBJECTIVES FOR THE FIRST DAY OF THE COURSE 13:30 LAYING THE FOUNDATIONS Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 BREAK 15:00 PATIENT PROTECTION Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 WORKSHOP 1 - CASE STUDY ON INFORMED CONSENT 16:45 END OF DAY QUESTIONS AND ANSWERS 17:00 CLOSE OF DAY DAY 2 08:50 QUESTIONS AND ANSWERS FROM DAY 1 09:00 EFFECTIVE SITE AUDITS The procedures involved in selecting and setting up audits at investigator sites. 09:40 WORKSHOP 1 - PLANNING THE EFFECTIVE AUDIT 10:30 BREAK 10:45 SOURCE DATA VERIFICATION The need for and purpose of verifying data. 11:25 WORKSHOP 2 - SOURCE DATA VERIFICATION 12:30 LUNCH 13:30 IMP MANAGEMENT The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 CRITICAL DOCUMENT AUDITS The conduct of other study specific audits including protocols, databases and reports. 15:00 BREAK 15:15 NON-COMPLIANCE Determining the acceptability of data. 16:00 FRAUD - FACT OR FICTION? How to identify fraud and its consequences 16:45 END OF DAY QUESTIONS AND ANSWERS 17:00 CLOSE OF DAY DAY 3 08:50 QUESTIONS AND ANSWERS FROM DAYS 1 AND 2 09:00 AUDITING THIRD PARTIES A review of audits of contract research organisations. 10:00 SYSTEM AUDITS The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 BREAK 11:00 WORKSHOP 3 - PROCESS MAPPING 11:45 EFFECTIVE AUDITS Where theory meets reality. 12:30 LUNCH 13:20 AUDIT REPORTS - CLOSING THE LOOP An examination of the processes which follow the evidence gathering phase of the audit. 14:20 WORKSHOP 4 - AUDIT REPORTS Audit reports, corrective and preventive action. 15:00 BREAK 15:10 REGULATORY INSPECTION Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 FINAL QUESTIONS AND ANSWERS 16:10 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 17 Points   DEVELOPMENT LEVEL Develop

This three-day investigation and interviewing skills course is an advanced course designed specifically for specialist investigators or those who undertake investigations on a full-time basis.

The "ISO 14298:2021 Lead Auditor Course" integrates the principles of ISO 14298:2021, the International Standard for Security Printing Management, with the methodologies outlined in ISO 19011:2018, the Guidelines for Auditing Management Systems. The course equips participants with the skills and knowledge required to lead security printing audits effectively, ensuring compliance with ISO 14298:2021, and applies the principles of ISO 17011:2017 for conformity assessment bodies. It covers audit planning, execution, and reporting while emphasizing risk management and continual improvement.

Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud and corruption.

Root Cause Analysis (RCA) is used to analyse the root causes of focus events with both positive and negative outcomes, but it is most commonly used for the analysis of failures and incidents. Causes for such events can be varied in nature, including design processes and techniques, organizational characteristics, human aspects and external events. RCA can be used for investigating the causes of non-conformances in quality (and other) management systems as well as for failure analysis, for example in maintenance or equipment testing.

ABOUT THIS VILT Tripod can be used in any area of business where the organisation has a management system in place to prevent unwanted events e.g., health, safety, environment, quality, security, productivity, project management, and many more Tripod Beta is one of several tools based on Tripod's fundamental principles. Tripod Beta is based on proven theories, man years of academic research, and testing in the workplace. The Swiss Cheese Model originated from this work. Features of the methodology are: 1) the Tripod Beta diagram; it provides an easy-to-read summary of the entire investigation on a single page, 2) it accommodates deficiencies in leadership and worker participation, 3) it accommodates deficiencies in human behaviour, and 4) it highlights missing controls (not just controls that failed). Quality throughout all aspects of Tripod is assured by the Stichting Tripod Foundation (STF) and the Energy Institute. The participants will gain a theoretical understanding of the Tripod Beta methodology and terminology. They will be able to read Tripod diagrams and reports, and be able to assist incident investigation/analysis as a team member.  This is the first step to becoming an accredited silver or gold practitioner. Tripod Beta Practitioner Accreditation is meant to build these skills, through a blend of support, coaching and assessments. Feedback is provided on Tripod incident investigation reports, giving the Practitioner the opportunity to hone their skills and become confident in their ability to use Tripod effectively. Training Objectives Upon completion of this course, participants will be able to: * Pass the Tripod Beta Practitioner (Bronze Level) exam * Act as a team member or Tripod facilitator on an incident investigation * Plan and schedule activities for an incident investigation * Focus line of enquiry during an investigation * Engage with the most relevant people at each stage of the investigation * Describe the incident causation paths in terms that align with their management system * Consider issues relating to leadership, worker participation and human behaviour * Assess the quality of an incident report * Apply the process to any type of unwanted event that should have been prevented by a management system e.g., health, safety, environment, financial, security, productivity, quality, project management etc. * Combine the findings from many incidents with data from other initiatives e.g., audits and inspections, to spot trends to prioritise actions and product a single improvement plan Target Audience The course is recommended for anyone who is expected to play a role in designing, reviewing, auditing, and following your organizations OH&S management system. Successful participants will be awarded the Stitching Tripod Foundation Tripod Beta Bronze certificate. The following oil & gas company personnel will benefit from the knowledge shared in this course: * CEO * Team Leaders * Legal, insurance and finance departments * Managers (Line and Function) * Maintenance Engineers * Quality Assurance Engineers * Process Engineers * Incident Investigators (Team member & Tripod facilitator) * Project Managers * System Custodians * Technical Authorities * Key Contractor's Management * Contract Managers/Holders * Safety Representatives * Risk Management Engineers * HSE Advisors * Supervisors * Auditors * Regulators Course Level * Basic or Foundation Trainer Your expert course leader has over 30 years of experience in construction, operations and maintenance with the upstream exploration and production sector. He joined Shell International E&P in 1971 and for 28 years worked in several locations around the world. Following the Piper Alpha incident he led Shell's two year, £10M major overhaul of their permit to work system. He first made use of the Tripod Beta principles during this period and since then he has delivered over 100 Tripod Beta courses in more than 25 locations around the world. He is a Chartered Engineer, a member of the Institution of Engineering and Technology and holds a postgraduate diploma from the University of Birmingham (UK). 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