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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.

Agile Release Plans: In-House Training While many Agile frameworks provide guidance on a focus on value and iterative development, many do not explain how that value is delivered to the customer. Release Plans have become an accepted and common practice to bridge the gap between the Product Vision and the Product Backlog (Agile requirements). In this course, you will be provided with an introduction to Agile and to Scrum, the most utilized Agile framework. You will also learn how the Vision, Roadmap, and Charter help to establish the Release Plan. The goal of this course is to equip you with the necessary knowledge, skills, and techniques to build Release Plans to ensure you deliver the most value to your customers. What you will Learn At the end of this program, you will be able to: Recall the Scrum framework elements (roles, events, and artifacts) Examine the benefits of Agile Develop a Product Vision and Roadmap Create an Agile Project Charter Prepare a Release Plan Write user stories to support a Product Backlog Foundation Concepts Introduction to Scrum Scrum Overview Agile Benefits Product Definition Business Goals Product Vision Product Roadmap Agile Project Charter Product Scope Project Risks Release Deadlines Sprint Durations Team Norms Release Planning Release Plan Process Select Stories and a Release Date Product Backlog User stories Building the product backlog Product Backlog Refinement Transitioning to the Scrum Team

Assuring Quality Through Acceptance Testing: In-House Training It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. It is the business analyst's job to define the business problem to be solved by IT. It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. The business analyst is not only concerned with the testing itself, but also with the management and monitoring of the users doing the acceptance testing, and recording, analyzing, and evaluating the results. What you will Learn Upon completion, participants will be able to: Create a set of acceptance test cases Manage and monitor an acceptance test stage where users perform the testing Work with the development team in the systems testing stage Assess the solution once it is in the business environment Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide BA roles and relationships through the project life cycle Introduction to assuring software quality through acceptance testing The Scope of IT Testing Overview of testing stages The testing process Testing documentation Pre-Acceptance Testing The BA's role in testing Early development testing stages (unit and integration) Late development testing stage (system) The Acceptance Test Stage - Part I (Planning, Design, and Development) Overview of user acceptance testing Acceptance test planning Designing user acceptance tests Developing individual user acceptance test cases Building effective user acceptance test scenarios The Acceptance Test Stage - Part II (Execution and Reporting) Operating guidelines Execution Reporting Post-Acceptance Testing Overview Project implementation Project transition (project closure) Production through retirement Testing Commercial Off-the-Shelf (COTS) Software Overview Selecting the software Implementing the software Summary What did we learn and how can we implement this in our work environments?

Earned Value Management: In-House Training: In-House Training Earned Value Management (EVM) incorporates a set of proven practices appropriate for project or program management methodologies. These include integration of program scope, schedule, and cost objectives, establishment of a baseline plan for accomplishment of program objectives and use of earned value techniques for performance measurement during the execution of a program. Earned Value Management (EVM) incorporates a set of proven practices appropriate for project or program management methodologies. These include integration of program scope, schedule, and cost objectives, establishment of a baseline plan for accomplishment of program objectives and use of earned value techniques for performance measurement during the execution of a program. EVM provides a solid platform for risk identification, corrective actions, and management re-planning as may be required over the life of a project or program. The course emphasis is on the latest EVM principles and concepts in accordance with changes and guidelines for Earned Value Management in The Guide to the Project Management Body of Knowledge (PMBOK® Guide) and The Practice Standard for Earned Value Management published by the Project Management Institute. What you Will Learn You'll learn how to: Develop a project baseline, using an effective WBS Record actual project performance Calculate EVM measures Evaluate project performance based on EVM measures Respond to project variances Integrate EVM and risk management Determine how EVM will add value to your organization Develop an EVM implementation plan for your organization Getting Started Introductions Course structure Course goals and objectives Expectations Foundation Concepts Introduction to Earned Value Management (EVM) Benefits of EVM EVM Process Overview Applications of EVM Creating a Work Breakdown Structure Reviewing WBS concepts Reviewing WBS development process (decomposition) Using a WBS to support EVM Building a Project Baseline Defining a project baseline Developing a project baseline Using a project baseline Recording Actuals Recording actuals overview Collecting data for actual project performance Determining earned value - various methods EVM Performance Measures Using current status measures Using forecasting measures Analyzing EVM measures EVM and Risk Management Integrating EVM and Risk Management Using EVM measures in the risk register Exploring how EVM can facilitate reserves management Drawing down contingency reserves Responding to Variances Introduction to variances Process for responding to variances Response options Reporting Project Performance EVM reporting overview Meeting EVM reporting needs Addressing EVM reporting challenges Implementing an EVMS Defining EVMS requirements EVM for Agile projects Tailoring the EVMS Summary and Next Steps Review of content Review of objectives / expectations Personal action plan

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

  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 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

  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