3565 RES courses in Cardiff delivered Live Online

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

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  The ISO 31000 Risk Manager training course helps participants acquire the knowledge necessary and ability to integrate the risk management guidelines of ISO 31000 in an organization. It provides information with regard to the risk management principles and their application, as well as the core elements of the risk management framework and steps for a risk management process. In addition, it provides the basic approaches, methods, and practices for assessing risk in a wide range of situations. Upon completion of the training course, you can sit for the exam and gain the "Certified ISO 31000 Risk Manager' credential. The credential demonstrates your knowledge and ability to apply the risk management process in an organization based on the guidelines of ISO 31000 and best practices. Who Should Attend?   Managers or consultants responsible for the effective management of risk in an organization Individuals seeking to gain knowledge about the risk management principles, framework, and process Individuals responsible for the creation and protection of value in their organizations Individuals interested in pursuing a career in risk management About This Course   Learning objectives Understand the risk management concepts, approaches, methods, and techniques  Learn how to establish a risk management framework in the context of an organization  Learn how to apply the ISO 31000 risk management process in an organization Understand the basic approaches, methods, and practices used to integrate risk management in an organization Educational approach The training course is based on theory and best practices used in risk management. Lecture sessions are illustrated with practical examples. The participants are encouraged to communicate and engage in discussions and exercises. The exercises are similar in structure with the certification exam questions. Course agenda Day 1: Introduction to ISO 31000 and risk management and establishing the risk management framework Day 2: Initiation of the risk management process and risk assessment based on ISO 31000 Day 3: Risk treatment, recording and reporting, monitoring and review, and communication and consultation according to ISO 31000; the examination. Prerequisites   A foundational understanding of ISO 31000 and knowledge of risk management What's Included?   Official Study materials Coffee's/Teas, refreshments and Lunch (Classroom courses only) The Exam fees Our Guarantee     We are an approved IECB Training Partner. You can learn wherever and whenever you want with our robust classroom and interactive online training courses. Our courses are taught by qualified practitioners with commercial experience. We strive to give our delegates the hands-on experience. Our courses are all-inclusive with no hidden extras.  The one-off cost covers the training, all course materials, and exam voucher. Our aim: To achieve a 100% first time pass rate on all our instructor-led courses. Our Promise: Pass first time or 'train' again for FREE. *FREE training and exam retake offered Accreditation Assessment   The examination is delivered in a 10 question essay type format, to be completed within 125 minutes and with a 70% pass mark. Exam results are provided within 24 hours. Provided by   This course is Accredited by NACS and Administered by the IECB.

  During this training course, you will acquire the knowledge and skills to plan and carry out internal audits in compliance with ISO 19011. About This Course   Based on a number of exercises, you will learn how to utilise audit techniques and become competent to manage an internal audit programme, communicate with customers, and manage conflict resolution. After acquiring the necessary expertise, you can sit for the exam and gain 'Certified ISO/IEC 27001: 2022 Internal Auditor' Certification. By holding this Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives By the end of this training course, the participants will be able to: Explain the concepts and principles of an information security management system (ISMS) based on ISO/IEC 27001: 2022 Analyse the ISO/IEC 27001: 2022 requirements for an ISMS from the perspective of an auditor Evaluate the ISMS conformity requirements Plan, conduct, and close an ISO/IEC 27001: 2022 compliance audit programme Assist an organisation in transitioning from ISO 27001: 2013 Deliver an ISO/IEC 27001: 2022 Internal audit programme Our approach This training is based on both theory and best practices used in ISMS audits Lessons are illustrated with examples based on case studies Practical exercises are based on a real world case study Practice tests are similar to the Certification Exam Course Overview Module 1 Foundational Audit principles and concepts of Information Security Management System (ISMS) Module 2 The Information Security Management System (ISMS) Module 3 ISO 19011 audit concepts and principles Module 4 Preparation of an ISO/IEC 27001 audit Module 5 Providing an ISO/IEC 27001 audit Module 6 Closing an ISO/IEC 27001 audit Module 7 Managing an ISO/IEC 27001 Internal audit programme Course Agenda Day 1: Introduction to the information security management system (ISMS) and ISO/IEC 19011 Day 2: Audit principles, preparation, and initiation of an audit Day 3: Audit activities, Closing the Audit and the Certification exam Accreditation Assessment   All candidates at official training courses are tested throughout their course with quizzes and exercises, in combination with a final exam held on the last day of the course. Both elements are a part of the overall score. For this course, the final exam constitutes a 10 question essay type which should be completed within 125 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store. Exam results are returned within 24 hours, with successful candidates receiving both a digital badge and a Certificate of Achievement Prerequisites     A general understanding of ISO/IEC 27001: 2022 and knowledge of audit principles.   Provided by   This course is Accredited by NACS and Administered by the IECB What's Included?   Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Guides CPD Certificate The Exam Who Should Attend?   Auditors seeking to perform Internal Information Security Management System (ISMS) certification audits Managers or consultants seeking to master an Information Security Management System audit process Individuals responsible for maintaining conformance with Information Security Management System requirements Technical experts seeking to prepare for an Information Security Management System audit Expert advisors in Information Security Management

This practitioner-level 4 award encourages individuals in IT and technical roles to explore the many teams, ideas, and functions within an organisation and maximise their contribution. You will achieve this by learning the key concepts and considering behaviour and response in different scenarios.

Learn the processes, practices and principles of project management described in the PRINCE2® approach and prepare for the Foundation and Practitioner examinations on this accredited programme. Duration: 5 days (32.5 hours) Our PRINCE2® Foundation and Practitioner Qualification course is designed to teach the processes, practices and principles of project management described in the PRINCE2® approach and to prepare delegates for the Foundation and Practitioner examinations, held as part of the course. This course is designed for existing and potential Project and Team Managers who would like to gain a comprehensive understanding of the PRINCE2® method of managing projects and will provide those responsible for planning and managing projects with a structure that will help, without imposing inflexible processes or stifling creative thinking. The PRINCE2® Foundation and Practitioner Course is based on the “Managing Successful Projects with PRINCE2® 7th Edition”, which describes the structured project management method. These are intensive modules and require delegates to undertake some evening work in their own time. Objectives  By the end of the course you will be able to be: Describe the background, principles, structure and terminology used in the PRINCE2® 7th Edition project management method Prepare for and take both the PRINCE2® Foundation and Practitioner Exams Please note that examinations are the responsibility of the examination board, PEOPLECERT and must be organised separately by each person attending. Content Introduction Introduction to projects and project management Structure Of PRINCE2® 7th Edition The seven Principles –the basis of what defines a PRINCE2 project People – leading successful change, teams and communication The seven Practices – to be addressed throughout the project The seven Processes - the activities to direct, manage and deliver a project successfully Practices Business case – establishing mechanisms to decide whether project is desirable, viable and achievable Organizing – establishing accountabilities and responsibilities Quality – defining mechanisms to ensure that products are fit for purpose Plans – the product based approach to planning Risk – identifying, assessing and controlling uncertainty Issues – identifying, assessing and controlling changes to the baseline and other issues Progress – monitoring actual achievements against estimate and controlling deviations Processes Starting up a Project - is there a viable and worthwhile project Directing a Project – enabling key decision making by the Project Board Initiating a Project – establishing solid foundations Controlling a Stage –assigning and monitoring work and keeping within stage tolerance Managing Product Delivery – controlling the link between the Project Manager and Team Manager(s) Managing a Stage Boundary – current stage review and next stage planning Closing a Project – confirmation of acceptance and project review Tailoring PRINCE2® - to the project environment Foundation Examination and results Practitioner Workshop and Examination PRINCE2® Practitioner Examination Objectives and Guidance PRINCE2® Review PRINCE2® Practitioner Examination Workshops PRINCE2® Practitioner Examination PRINCE2® Foundation and Practitioner Examinations The PRINCE2® Foundation Exam is of 1 hour duration and consists of 60 multiple choice questions. A Pass is 36 correct answers, 60%. The PRINCE2® Practitioner Exam is a written paper of 2.5 hours duration. There are 70 Objective Test style questions to be answered in the 2.5 hours and the candidate may use an annotated manual. The candidate must score 42/70 to be successful, 60%.   Presented in association with aims4change, a PEOPLECERT Accredited Training Organisation. PRINCE2® is a Registered Trade Mark of AXELOS Limited.

Disciplined Agile Scrum Master (DASM): Virtual In-House Training Is your team treading water using waterfall? Do you feel trapped in an agile framework? Would you like to find solutions to the problems you've been wrestling with? Are you looking for ways to enhance your team's agility? Break free from your old ways by choosing a way of working that fits your team's context. Find strategies to improve your processes and strengthen your team with the Disciplined Agile® tool kit. Disciplined Agile Scrum Master is a nine-lesson, instructor-led course that shows you how to use Disciplined Agile (DA™) to improve your team's way of working. In just two days, you will become familiar with foundational agile and lean practices that DA supports, practice using the tool kit to solve problems, and learn how to build high-performance teams. Filled with activities, animations, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Scrum Master (DASM) exam and, equally important, start using Disciplined Agile immediately. #BBD0E0 » What You Will Learn After the completion of this course, you will be able to: Apply foundational agile and lean practices in your own team setting Describe what business agility is and how it is core to value proposition of Disciplined Agile® Describe the significance of the Disciplined Agile mindset Define the DA™ principles, promises, and guidelines and how they set Disciplined Agile apart from other frameworks Explain how people are organized into DA teams Define the primary DA roles and how they each are key to the success of a self-organizing agile team Explain how to help your team work well together using the Lean principle of 'respect people' Analyze your team's context to make better process-related decisions Select the best-fit DA life cycles for your teams Apply the five DA steps of choosing your team's way of working (WoW) Apply the relevant agile and lean techniques to successfully initiate your team Apply the relevant agile and lean techniques to support your team producing business value Apply the relevant agile and lean techniques to support your team releasing their work into production Apply the relevant agile and lean techniques to support your team on an ongoing basis Recognize when to be resilient List and define the principles of Lean Significance of the Disciplined Agile® Mindset Business agility and how it is core to value proposition of Disciplined Agile Eight DA principles and how they are core to what sets Disciplined Agile apart from other agile frameworks Which situations each of the DA™ life cycles is best applied DA Practice of choosing a team's way of working (WoW) Foundations of Agile How people are organized into DA teams Primary DA roles and how they each are key to the success of a self-organizing agile team Help your team work well together (Lean principle 'Respect people') Inception phase and why it is important DA tool kit to tailor your way of working within a select phase according to context Agile techniques and ceremonies relevant to Inception Construction phase and why it is important Agile techniques and ceremonies that take place during Construction Eliminate Waste and Build Quality (Lean principles) Deliver Value Quickly (Lean principle) Transition phase and why it is important Ongoing phase and why it is important Learn Pragmatically (Lean principle) Elements of the process blade (onion) diagram Principles of Lean When to be resilient Benefits of explicit workflow Kaizen loops and PDSA techniques for continuous improvement Options for cross-team learning: "community of practice" and "center of excellence"

  The IECB Certified ISO 37001 Internal Auditor training course provides the necessary knowledge and skills that enable you to perform anti-bribery management system (ABMS) audits by applying widely recognized audit principles, procedures, and techniques. About This Course   Many organizations seek competent auditors to determine whether the policies and anti-bribery controls, implemented as part of an ISO 37001-based ABMS, are effective. This training course aims to help you complete these tasks successfully and intends to reflect the importance of effective ABMS audits. Additionally, it aims to strengthen your knowledge and skills to plan and carry out ABMS audits in compliance with the guidelines for auditing management systems provided in ISO 19011 and the certification process described in ISO/IEC 17021-1. The exercises, quizzes, and case studies provided are designed to help you practice the most important aspects of an ABMS audit: ISO 37001 requirements, auditing principles, tools and techniques used to obtain evidence, leading a team of auditors, conducting interviews with auditee, reviewing documented information, drafting nonconformity reports, and preparing the final audit report. The successful completion of the training course is followed by an exam. If you pass the exam, you gain the 'Certified ISO 37001 Lead Auditor' credential which validates your professional capabilities and demonstrates your ability to audit an ABMS based on ISO 37001. Learning objectives By the end of this training course, the participants will be able to: Explain the foundational concepts and principles of an anti-bribery management system (ABMS) based on ISO 37001 Interpret the ISO 37001 requirements for an ABMS from the perspective of an auditor Evaluate the ABMS conformity to ISO 37001 requirements, in accordance with the foundational audit concepts and principles Plan, conduct, and close an ISO 37001 compliance audit, in accordance with ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and other best practices of auditing Manage an ISO 37001 Internal audit programme Educational approach This training course is participant centred and contains: Theories, approaches, and best practices used in anti-bribery management system auditing Lecture sessions, which are illustrated with case studies inspired by real events and practical exercises based on a case study that includes role-playing and discussions Interaction between participants by means of questions and suggestions Course Overview Module 1 Foundational principles and concepts of an anti-bribery management system Module 2 Anti-bribery management system requirements Module 3 Foundational audit concepts and principles Module 4 Preparing an ISO 37001 audit Module 5 Conducting an ISO 37001 audit Module 6 Closing an ISO 37001 audit Module 7 Managing an ISO 37001 Internal audit programme Course Agenda Day 1: Introduction to the anti-bribery management system (ABMS) and ISO 37001 Day 2: Audit principles and the preparation for and initiation of an audit Day 3: On-site audit activities, Closing of the Audit and the Certification exam Accreditation Assessment     All candidates at official training courses are tested throughout their course with quizzes and exercises, in combination with a final exam held on the last day of the course. Both elements are a part of the overall score. For this course, the final exam constitutes a 10 question essay type exam which should be completed within 125 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store. Exam results are returned within 24 hours, with successful candidates receiving both a digital badge and a Certificate of Achievement   Prerequisites   A foundational understanding of ISO 37001 requirements for an ABMS and a comprehensive knowledge of audit principles. What's Included?   Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Guides CPD Certificate The Exam Provided by   This course is Accredited by NACS and Administered by the IECB Who Should Attend?   The ISO 37001 Internal Auditor training course is intended for: Auditors seeking to perform and lead ABMS audits Managers or consultants seeking to master the ABMS audit process Individuals responsible for maintaining conformity to ISO 37001 requirements in an organization Technical experts seeking to prepare for an ABMS audit Expert advisors in anti-bribery management  

  The IECB ISO 14001 Internal Auditor training course enables you to acquire the necessary competencies to conduct effective environmental management system (EMS) audits by applying widely recognized audit principles, procedures, and techniques. About This Course   This training course combines the requirements of ISO/IEC 17021-1, the recommendations of ISO 19011, and other best practices of auditing and integrates them into a comprehensive methodology which enables you to effectively plan and conduct ISO 14001 conformity assessment audits. In addition to providing a solid theoretical foundation, this training course adopts a practical approach by incorporating examples, exercises, and quizzes that help you practice the most important aspects of conformity assessment audits, such as the interpretation of ISO 14001 requirements in the context of an audit, the application of auditing principles and methods, the utilization of approaches to evidence collection and verification, leading an audit team, drafting nonconformity reports, and preparing the final audit report. After completing the training course, you can sit for the exam. After passing the exam, you gain the 'Certified ISO 14001 Lead Auditor' credential, which validates your professional expertise and demonstrates that you have the knowledge and skills to audit environmental management systems that are based on the requirements of ISO 14001.   Learning objectives By the end of this training course, the participants will be able to: Explain the foundational concepts and principles of an environmental management system (EMS) based on ISO 14001 Interpret the ISO 14001 requirements for an EMS from the perspective of an auditor Evaluate the EMS conformity to ISO 14001 requirements, in accordance with the foundational audit concepts and principles Plan, conduct, and close an ISO 14001 compliance audit, in accordance with ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and other best practices of auditing Manage an ISO 14001 audit programme   Educational approach This training course is participant centred and: Elaborates theories, approaches, and best practices used in EMS audits Provides practical exercises which are based on scenarios inspired by real-life events Encourages interaction between the trainer and participants by means of questions and suggestions Provides quizzes consisting of stand-alone and scenario-based questions, tailored to prepare the participants for the certification exam   Course overview Module 1 Foundational principles and concepts of an environmental management system Module 2 Environmental management system requirements Module 3 Foundational audit concepts and principles Module 4 Preparing an ISO 14001 audit Module 5 Conducting an ISO 14001 audit Module 6 Closing an ISO 14001 audit Module 7 Operating an ISO 14001 audit programme   Course Agenda Day 1: Introduction to the environmental management system (EMS) and ISO 14001 Day 2: Audit principles and the preparation for and initiation of an audit Day 3: On-site audit activities, Closing of the audit and the Certification exam Provided by   This course is Accredited by NACSand Administered by the IECB Accreditation Assessment   All candidates at official training courses are tested throughout their course with quizzes and exercises, in combination with a final exam held on the last day of the course. Both elements are a part of the overall score. For this course, the final exam constitutes a 10 question essay type exam which should be completed within 125 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store. Exam results are returned within 24 hours, with successful candidates receiving both a digital badge and a Certificate of Achievement Prerequisites   In order to fully benefit from this training course, participants should have an understanding of environmental concepts, ISO 14001, and audit principles. What's Included?   Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Guides CPD Certificate The Exam Who Should Attend?   The ISO 14001 Internal Auditor training course is intended for: Auditors seeking to conduct internal EMS audits Managers or consultants seeking to master the EMS audit process Individuals responsible for maintaining conformity to the requirements of ISO 14001 in an organization Technical experts seeking to prepare for EMS audits Expert advisors in environmental management