This highly interactive program focuses on building the business focus on value to be achieved from initiatives. The practices in this program apply equally to projects and programs. Participants will gain insight into the capabilities needed to develop the culture, processes, and tools behind validation, what true initiatives' success looks like, which can be closely linked to achieving value. They will learn and experiment with a variety of value definition and management techniques. Working in small groups, they will collaborate with others to brainstorm, share experiences, and apply concepts to the ongoing value confirmation goal. Participants will also discover the importance of designing metrics around value and addressing blind spots that could happen when the focus is on the wrong metrics and how that could lead to the wrong behaviors being practiced. Participants will also gain insights into key skills for leading and working in the future. Hands-on experimentation activities enhance the theoretical learning, grounding it in real life and giving opportunities to practice creativity in capturing value.
Portfolio Management for Stakeholders: In-House Training This course equips and enables project, program, and functional managers (line managers) to support and contribute to starting, restarting or sustaining the implementation and effectiveness of portfolio management in an organization. Emphasis is on improving collaboration and planning between functional business areas and project/program organizations responsible for delivering investments in business change through successful delivery of projects and programs. Good functional, project, and program managers become 'great' when they understand, advocate, and effectively contribute to achieving 'real' business value through portfolio management. What you Will Learn At the end of this program, you will be able to: Outline the benefits of portfolio management State the importance of linking the strategic objectives to the initiatives in the organization Chart the portfolio governance structure Assist in the inventory of ongoing and new initiatives Identify portfolio and sub-portfolio categories Support the PMO in the prioritization of initiatives using Multi-criteria Analysis and other selection tools Collaborate with the PMO in balancing the portfolio based on the optimal use of resources and priorities Participate in resource forecasting and planning Demonstrate thresholds and variance reporting criteria Describe the purpose of Stage Gate Funding Report status against a portfolio delivery plan Present your initiative in Stage Gate Reviews List the benefits that are being realized by the initiative Foundation Concepts Portfolio Life Cycles Portfolio Governance Prioritizing Initiatives Prioritize Foundation Multi-Criteria Analysis Analytical Hierarchy Process (AHP) Strategic Alignment Balancing the Portfolio Resources, Budgets, and Equipment Communicating Decisions Planning the Portfolio Planning Review Cycles Using Stage Gate Funding Setting Thresholds and Variance Reporting Tool Examples Portfolio Delivery 'Cycle' Project and Program Life Cycles Stage Gate Reviews Interaction with the Portfolio Delivery Board Project, Program, and Functional Managers Roles and Responsibilities
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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
Global leading Asset Management course online. This online IAM Certificate course will be hosted through Teams.
The IECB ISO 9001 Internal Auditor training course enables you to develop the necessary competence to perform quality management system (QMS) 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 good practices of auditing and integrates them into a comprehensive methodology which enables you to successfully plan, conduct, and close ISO 9001 conformity assessment audits. Apart from a theoretical basis, the training course also provides examples, exercises, and quizzes to help you practice the most important aspects of conformity assessment audits: interpretation of ISO 9001 requirements in the context of an audit, principles of auditing, application of audit methods, approaches to evidence collection and verification, leading an audit team, drafting nonconformity reports, and preparing the final audit report. The successful completion of the training course is followed by an exam. If you successfully pass the exam, you gain the 'Certified ISO 9001 Internal Auditor' credential. This certificate validates your professional capabilities and demonstrates that you have the knowledge and skills to audit a QMS based on ISO 9001. Learning objectives By the end of this training course, the participant will be able to: Explain the foundational concepts and principles of a quality management system (QMS) based on ISO 9001 Interpret the ISO 9001 requirements for a QMS from the perspective of an auditor Evaluate the QMS conformity to ISO 9001 requirements, in accordance with the foundational audit concepts and principles Plan, conduct, and close an ISO 9001 compliance audit, in accordance with ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and other best practices of auditing Manage an ISO 9001 audit programme Educational approach This training course is participant centred and contains: Theories, approaches, and best practices used in ISO management system audits Lecture sessions illustrated with examples based on case studies Practical exercises based on a case study Interaction between participants by means of questions and suggestions Stand-alone and scenario-based quizzes, tailored to prepare the participants for the certification exam Course Overview Module 1 Foundational principles and concepts of a quality management system Module 2 Quality management system (QMS) requirements Module 3 Foundational audit concepts and principles Module 4 Preparing an ISO 9001 audit Module 5 Conducting an ISO 9001 audit Module 6 Closing an ISO 9001 audit Module 7 Managing an ISO 9001 Internal audit programme Course Agenda Day 1: Introduction to the quality management system (QMS) and ISO 9001 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 The main requirements for participating in this training course are a foundational understanding of ISO 9001 requirements for a QMS 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? The ISO 9001 Internal Auditor training course is intended for: Auditors seeking to perform and lead QMS audits on behalf of their organisation bodies Professionals wishing to adopt a recognised methodology for conducting audits based on ISO 19011 Individuals responsible for maintaining conformity to the requirements of ISO 9001 Technical experts seeking to prepare for a QMS audit Professionals wanting to pursue a career in conformity assessment
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.
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 About This Course Learning outcomes 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 Course Overview Domain 1-The Process of Auditing Information Privacy Systems & Solutions Domain 2-Governance & Management of Information Privacy Technology Domain 3-Information Systems Acquisition, Development & Implementation Domain 4-Information Systems Operations, Maintenance & Service Management Domain 5-Protection of Personally Identifiable Information (PII) Assets Course Agenda Day 1: Introduction to Privacy Information Management System (PIMS) and ISO/IEC 27701 Day 2: Audit principles, preparation, and launching of an audit Day 3: On-site audit activities and Closing the Audit Accreditation This course is Accredited by NAS and Administered by the IECB Assessment All candidates at official training courses will be tested throughout the course delivery, with quizzes and exercises. The final exam is a 10 question essay type exam, offered on the afternoon of the final day. This exam should be completed within 180 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store. Prerequisites None, but candidates would benefit from having a fundamental understanding of Audit principles What's Included? Comprehensive course materials totalling some 450 pages Case Study Exam fees Exam pass guarantee 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)
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