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ISO 7101 Healthcare Quality Management System Lead Auditor Course provides participants with the knowledge and skills necessary to lead audits of quality management systems within healthcare organizations. This comprehensive training program covers the principles, processes, and practices of auditing healthcare quality management systems, focusing on key standards and regulations applicable to the healthcare industry.

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.

  Being ISO 27701 Certified proves your Information Privacy Systems Audit experience, skills and knowledge, and demonstrates you are capable in the assessment of vulnerabilities, Compliance with GDPR and institutional controls within the enterprise.   Gain an in-depth understanding of GDPR solutions and how they map to compliance requirements Learn how to perform and lead Privacy Information Management System (PIMS) certification audits to ISO 19011 standards Enhance your existing or learn with new skills in the field of Data Protection Candidates deliver Assurance services to organisations by advising on conformance with PIMS requirements Become a Technical expert on the preparation required for ISO 27701 Certification Understand a Privacy Information Management System (PIMS) and its processes based on ISO/IEC 27701 Identify the relationship between ISO/IEC 27701, ISO/IEC 27001, ISO/IEC 27002, and other standards and regulatory frameworks Acquire the competences of the auditor's role in planning, leading, and following up on a management system audit in accordance with ISO 19011. Learn how to interpret the requirements of ISO/IEC 27701 in the context of a PIMS audit About This Course   ISO 27701 Internal Auditor Certification;    Confirms your knowledge and experience Quantifies and markets your expertise Demonstrates that you have gained and maintained the level of knowledge required to meet the dynamic challenges of a modern enterprise Is globally recognized as the mark of excellence for the Information Privacy Audit professional Increases your value to your organization Gives you a competitive advantage over peers when seeking a new role Is administered by the International Examination & Certification Board (IECB), based in Estonia, and fully aligned to the ISO/IEC 17024:2012 standard (Conformity assessment - General requirements for bodies operating certification of persons)   Certified Individuals:    Are highly qualified, experienced professionals in the field of Data Protection Systems Audit Provide the enterprise with a Certification route for Information Privacy Assurance that is recognized by multinational clients, lending credibility to the enterprise Are excellent indicators of proficiency in control requirements creation and monitoring Demonstrate competence in five domains, including standards and practices; organization and management; processes; integrity, confidentiality and availability; and software development, acquisition and maintenance Demonstrate a commitment to providing the enterprise with trust in and value from your Privacy Compliance Framework Maintain ongoing professional development for successful on -the -job performance   The below job practice is organized by domains. Each domain is covered in the course.   Domain 1-The Process of Auditing Information Privacy Systems and Solutions   Provide audit services in accordance with ISO 19011 audit standards to assist the organization in protecting and controlling information privacy systems.    Domain 2 - Governance and Management of Information Privacy Technology   Provide assurance that the necessary leadership and organizational structures and processes are in place to achieve objectives and to support the organization's strategy.    Domain 3-Information Systems Acquisition, Development and Implementation   Provide assurance that the practices for the acquisition, development, testing and implementation of information systems meet the organization's strategies and objectives.    Domain 4-Information Systems Operations, Maintenance and Service Management Provide assurance that the processes for information systems operations, maintenance and service management meet the organization's strategies and objectives.   Domain 5-Protection of Personally Identifiable Information (PII) Assets   Provide assurance that the organization's policies, standards, procedures and controls ensure the confidentiality, integrity and availability of PII.   Prerequisites   A thorough understanding of current Data Protection legislation, Information Security & Risk Management knowledge as well as ISO 19011 Auditing Standards is required to successfully pass the examination. What's Included?   Teas, Coffees, refreshments and a full Lunch* Course Slides Study Guide Exam Fees * For Classroom based Courses only Accreditation   Who Should Attend?   Auditors seeking to perform and lead Privacy Information Management System (PIMS) certification audits Managers or consultants seeking to master a PIMS audit process Individuals responsible for maintaining conformance with PIMS requirements Technical experts seeking to prepare for a PIMS audit Expert advisors in the protection of Personally Identifiable Information (PII)   Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 3 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. 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 offered for retakes - come back within a year and train for free. 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

  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  

  ISO 45001 is the first global occupational health and safety management system standard that replaces OHSAS 18001. The IECB Certified ISO 45001 Lead Auditor training course helps in developing the necessary skillset to perform occupational health and safety management system (OH&S MS) audits by applying widely recognized audit principles, procedures, and methods.   About This Course   This training course has been developed to reflect the importance of an effective internal audit. It strengthens your knowledge and skills to plan and carry out an OH&S MS audit 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 provided for this training course are designed to help you practice the most important aspects of an OH&S MS audit: ISO 45001 requirements, auditing principles, tools and techniques used to obtain evidence, leading a team of auditors, conducting interviews with auditees, 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 45001 Internal Auditor' credential, which validates your professional capabilities and demonstrates your ability to audit an OH&S MS based on ISO 45001.   Learning objectives By the end of this training course, the participants will be able to: Explain the foundational concepts and principles of an occupational health and safety management system (OH&S MS) based on ISO 45001 Interpret the ISO 45001 requirements for an OH&S MS from the perspective of an auditor Evaluate the OH&S MS conformity to ISO 45001 requirements, in accordance with the foundational audit concepts and principles Plan, conduct, and close an ISO 45001 internal audit, in accordance with ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and other best practices of auditing Manage an ISO 45001 internal audit programme   Educational approach This training course is participant centred and contains: Theories, best practices used in occupational health and safety management auditing Lecture sessions, which are illustrated with practical exercises based on a case study that includes role-playing and discussions Interactions, made between participants by means of questions and suggestions Quizzes, which are a simulation and preview of the certification exam   Course Overview Module 1 Foundational principles and concepts of an occupational health and safety management system Module 2 ISO 45001 requirements for an OH&S MS - Clauses 4 to 10 Module 3 Foundational audit concepts and principles Module 4 Preparing for an ISO 45001 audit Module 5 Conducting an internal ISO 45001 audit Module 6 Closing an ISO 45001 audit Module 7 Managing an ISO 45001 internal audit programme   Course Agenda Day 1: Introduction to OH&S MS and ISO 45001 Day 2: Audit principles and the preparation for and initiation of an audit Day 3: On-site audit activities and closing the audit, as well as 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   The main requirements for participating in this training course are: a foundational understanding of ISO 45001 and a comprehensive knowledge of audit principles. Provided by   This course is Accredited by NACSand 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 interested in performing OH&S MS internal audits Managers or consultants interested in advancing their knowledge of the OH&S MS audit process Internal auditors and individuals responsible for maintaining conformity to the requirements of ISO 45001 Technical experts interested in preparing for an OH&S MS audit Expert advisors in occupational health and safety management