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  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

  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

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Disciplined Agile Senior Scrum Master (DASSM): Virtual In-House Training Do you want to take Disciplined Agile® to a new level? Are you looking for tools to solve complex problems and enhance your organization's agility? Do you want to learn how to lead your team to excellence? Expand your knowledge and build practical skills around Disciplined Agile®, business agility, leadership, and team development. Disciplined Agile Senior Scrum Master is a nine-lesson, instructor-led course that shows you how to use the Disciplined Agile tool kit to solve a variety of advanced problems, work with allies within your organization, and optimize how teams work. You will gain knowledge in planning, reporting and metrics, and coordinating activities, as well as how to meet challenges in these areas. And you'll develop the skills you need to foster emotional intelligence, resolve conflicts, and lead high-performance teams at any stage of development. Filled with activities, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Senior Scrum Master (DASSM) exam and, equally important, start using Disciplined Agile immediately within your leadership role. What You Will Learn After the completion of this course, you will be able to: Accelerate your ability to lead high-profile initiatives that are critical to enterprise success Take a deep dive into the Disciplined Agile® tool kit to develop a comprehensive understanding of the hundreds of practices and strategies it contains and the trade-offs of applying them Apply the Disciplined Agile tool kit in hands-on exercises to guide your team in choosing and evolving your best way of working (WoW) in real-life situations Use the tool kit to solve complex challenges commonly encountered in development and operational teams, the value stream, and at the enterprise level Learn how to design and implement metrics that measure your improvements in areas where your teams are struggling Understand how to nurture emotional intelligence Feel confident empowering others on your team(s) Learn how to lead your teams in any situation to improve value delivery for your customers Apply the Disciplined Agile tool kit to guide your team in choosing and evolving the best way of working (WoW) in the situation you face Be prepared to take the Disciplined Agile® Senior Scrum Master (DASSM) exam and earn a valuable, credible certification Roles and responsibilities of DASSM Tuckman Team Development Model Emotional intelligence and why it is essential to team performance Business agility Tactical scaling factors in more complex situations Disciplined DevOps layer 'Test-first' method as it relates to the quality of requirements Scope and purpose of the value stream layer Coordinate activities process goal and why it is important Value creation structure of teams DA™ tool kit to optimize the flow of work and solve challenges related to coordinating and collaborating across teams, or within a larger team of teams Thomas-Kilmann Conflict Resolution Planning Five levels of scope Metrics

The course will be delivered through 9 online virtual classroom sessions. The 10th and last session will involve the additional practical work for the course as well as the written examination (multiple choice for City & Guilds and written for Hi-Tech Training) which will take place at our training centre at 43 North Great Georges Street, Dublin 1 (completed online for non ROI learners). During the virtual classroom sessions, trainees will have a live video feed with their instructor talking to them, doing practical live demonstrations on equipment being involved actively in the learning. We will send out a practical kit so that trainees can complete assignments and practical work at home. The kit is the property of Hi-Tech Training and will be returned to Hi-Tech Training on the last day of the course. (The kits may also be purchased by the learner….see the Kits Page Link for more details). The kit consists of power supply unit breadboard, multimeter, cables, The kit consists of breadboard, multimeter, oscilloscope, battery and connectors, components including resistors, LEDs and ICs (AND, NAND, OR, NOR, X-OR, X-NOR, Inverter, Buffer, Latches, Flip-Flops, Timers, etc). Trainees will build various projects as part of the course. The kit forms an integral part of the course, so full course fees need to be paid at least 7 days prior to course commencement to allow time to ship the kit in time for the course.

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

Project Management Fundamentals for IT Projects: In-House Training A number of factors impact the new project manager's role within IT - for instance, the need to fully integrate IT into the business improvement process and the advent of distributed technology and Business Process Reengineering. As a result, the range of activities required of a new project manager has greatly increased, as well as the range of people with whom he or she interacts. This workshop enables you to minimize the problems inherent in managing a systems development project. What You Will Learn You'll learn how to: Articulate the benefit of using a project management methodology, processes, and various life cycles for IT projects Articulate on various standards and maturity models that provide benefits to performing organizations that manage IT projects Describe governance, gating, and the processes required for project origination Conduct a stakeholder analysis and describe its benefits throughout the project life cycle Gather good requirements, develop a work breakdown structure (WBS), and establish a baseline project plan Execute against the baseline project plan while managing change and configuration items Monitor and control the project activities using the baseline project plan and earned value management concepts Close the project by conducting scope verification, procurement audits, gathering lessons learned, archiving project records, and releasing resources Getting Started Course goal Course structure Course goals and objectives Foundation Concepts Key definitions and concepts Methodologies, processes, and project life cycles Project success factors and the benefits of standards and models Project Originating and Initiating Originating projects Initiating projects Planning Stakeholder Engagement and Resource Management Planning stakeholder engagement Planning human resources management Developing effective leadership skills Planning Scope and Quality Management Planning project scope Planning project quality Planning Schedule Management Planning project time Identifying schedule activities Sequencing schedule activities Estimating activity resources and time Developing project schedule Optimizing the project schedule Planning Risk and Cost Management Planning for project risks Planning project costs Estimating project costs Developing a project budget Planning Communication and Procurement Management Planning project communications Planning project procurements Project Executing, Monitoring and Controlling, and Closing Project executing Project monitoring and controlling Project closing

Risk Management for IT Projects: In-House Training IT projects may have direct bottom-line impact on the organization, cost millions of dollars, cause organizational change and change the way the organization is perceived by clients. Many IT projects are notoriously hard to predict and are filled with risk. IT Risk Management takes a comprehensive look at IT project risk management using PMI's PMBOK® Guide Risk Management Model in the context of IT Project Life Cycle phases. The goal of this course is to arm the practitioner with a rigorous, common-sense approach to addressing uncertainty in projects. This approach includes the ability to influence project outcomes, avoid many potential project risks, and be ready to calmly and efficiently respond to unavoidable challenges. What you will Learn You'll learn how to: Describe the risk management process, using the PMBOK® Guide's standard models and terminology Discuss the potential barriers to managing risk effectively in IT project organizations Develop an effective risk management plan for IT projects Identify project risks using IT-specific, practical tools Analyze individual risk events and overall project risk using IT-specific, practical approaches Plan effective responses to IT-specific risk based on the results of risk analysis and integrate risk responses into project schedules and cost estimates Manage and control risk throughout the IT project life cycle Implement selected elements of IT project risk management on your next project Foundation Concepts Basic concepts and purpose Risk and project constraints Risk and corporate cultures Risk management and IT PLC standards Plan Risk Management for IT Projects Plan Risk management process Plan Risk management activities Design a standard template Assess the project-specific needs Tailor the template Produce a project-specific risk management plan Gain consensus and submit as part of overall project plan A risk management plan of IT projects Identify Risks for IT Projects Identify risk process overview Risk categories and examples Risk identification tools Risk events by project life-cycle phases Perform Risk Analysis for IT Projects Perform qualitative risk analysis overview Core qualitative tools for IT projects Auxiliary qualitative tools for cost and schedule estimates When to use quantitative analysis for IT projects Plan Risk Response for IT Projects Plan risk response overview Active risk response strategies for IT projects (Threat and Opportunity) Acceptance and contingency reserves Contingency planning for IT projects Plan risk responses for IT projects Implement Risk Response for IT Projects Implement Risk Responses Executing Risk Response Plans Techniques and Tools Used Continuous Risk Management Monitor Risks for IT Projects Monitor risks overview Monitor risks tips for IT projects Technical performance measurement systems Risk management implementation for IT projects

Implementing Scrum for Teams: In-House Training Scrum is an iterative, incremental framework for developing products. It allows the team to deliver a potentially shippable set of functionalities for each iteration, providing the agility needed to respond to rapidly changing requirements. These characteristics have led to Scrum becoming the most popular method in the world of Agile projects. This two-day course provides a practical approach to implementing the Scrum method on your projects. You will learn how to initiate a Scrum project, how to build a Product Backlog, containing user stories, and how to plan and estimate releases and iterations. You will learn how to conduct Scrum events, such as the Sprint Planning Meeting, and how to track progress during an iteration. You will apply what you learn in a series of hands-on, team-based activities and simulations that take you through the entire Scrum process. The overall goal of the course is to enable you to successfully apply the Scrum method on appropriate projects in your environment. What you will Learn At the end of this program, you will be able to: Teach-back Agile and Scrum foundation concepts Initiate a Scrum Project Conduct Team Sprint Planning and Sprint Review meetings Develop Release Plans (including effective user stories and priorities) Build a Sprint plan (including effective estimates) Executive a Sprint (including essential Scrum ceremonies) Implement Scrum in your environment Foundation Concepts Agile Mindset, Values, and Tenets Agile Benefits and Methods Scrum Overview Teams: Self-Managing, Self-Organizing, and Self-Improving Initiating a Scrum Project 'Sprint Zero' Activities Defining the Vision The Product Backlog and User Stories Acceptance Criteria Story Map Planning Releases Planning releases Estimating user stories Prioritizing user stories Selecting a Sprint length Estimating velocity Creating a release plan Planning a Sprint The Sprint Planning Meeting Building the Sprint Backlog Creating a Sprint Plan Running a Sprint Conduct a Sprint Burn-down and Burn-up Charts Negotiating Changes During a Sprint The Sprint Review Meeting Sprint Retrospective Releasing into Production Closing the Scrum Project Implementing Scrum Scrum Simulation Exercise Conditions of Success for Implementing Scrum