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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

City & Guilds 18th edition course with 2382-22 final exam only £234.00. Exams available every week across the UK, same day results, quick certificate, best prices..

PfMP® Exam Prep This is an intensive PfMP® Exam preparation course. This learning experience guides you through the multi-faceted discipline of portfolio management by focusing on the related technical, leadership, and business skills required to navigate it in the real world. First and foremost, this is an intensive PfMP® exam preparation course. Over the course, we go beyond exam prep to provide selected practice in applying key portfolio management skills, tools, and techniques. This learning experience guides you through the multi-faceted discipline of portfolio management by focusing on the related technical, leadership, and business skills required to navigate it in the real world. The journey zooms in and out between governance context and specific operational activities. The ultimate goal is practical application, with the bonus of certification along the way. What You Will Learn By the end of this program, you will be able to: Align and manage the portfolio, strategically, to satisfy organizational objectives and priorities, through benefit realization Articulate and emulate the role of a portfolio manager Apply the principles and skills of a portfolio manager to your real-world environment Study and prepare for the PfMP® Examination Apply for the certification, per the PMI PfMP Handbook and pass the initial panel review on your application Getting Started Course Overview Details of the PfMP® Certification process Foundation Concepts Projects, program, and portfolios A portfolio management process Strategy and value The role of the portfolio manager The role of key stakeholders Life cycle management The Portfolio Life Cycle Overview of Life Cycle Portfolio Management Information System (PMIS) Governance within the Portfolio Life Cycle Strategic Management Strategy concepts Supporting documentation and the strategic plan Planning and optimization Organizational risk appetite Managing strategic change Governance Management Overview and Guiding Principles The Concept of Governance Effective Design Factors Governance Roles Capacity and Capability Management Overview and Guiding Principles Capacity Management and Planning Supply and Demand (Management and Optimization) Organization Capabilities (Assessment and Development) Performance Management (Reporting, Analytics, and Balance) Stakeholder Engagement The Importance of Stakeholders Overview and Guiding Principles Definition and Identification Analysis and Planning Communications Approaches and Management Value Management Overview (Guiding Principles, Definition, and Components) Negotiating Expected Value Maximizing Value Assuring Value Realizing Value Measuring and Reporting Value A Look at Tools Risk Management Overview and Guiding Principles Portfolio Risk Planning Portfolio Risk Identification Portfolio Risk Assessment Portfolio Risk Response Examination Content Outline (ECO) Overview Structure Strategic Tasks Mapping Governance Tasks Mapping Performance Tasks Mapping Risk Tasks Mapping Communication Tasks Mapping List of Knowledge and Skills Exam Prep and Practice Overview Documenting experience Submitting the application Preparing to sit for the exam

PMI-PBA® Exam Prep The course provides targeted exam preparation support for PMI®'s Professional in Business Analysis exam candidates, including a content review of The PMI Guide to Business Analysis, a review of the PMI-PBA® reference books, and an exam preparation tutorial. You will be given a Study Guide that you can re-use to assess your knowledge gaps as part of your Personal Action Plan. Your score on this for each Knowledge Area can be compared to your results on the quiz at the end of each course module to guide your study efforts. What you will Learn Upon completion, participants will be able to: Demonstrate familiarity with the structure, content and framework of The PMI Guide to Business Analysis Explain the six Knowledge Areas of The PMI Guide to Business Analysis, as well as, their inter-relationships with each other and the six Process Groups Differentiate among the five business analysis domains in the project life cycle Create a personal action plan to study and prepare for the PMI-PBA® Exam Getting Started PMI-PBA Examination Certification Process The Credential Examination Foundation Concepts for PMI-PBA® Prep Business analysis terminology and definitions Business analysis project, program, and portfolio management Product and project life cycles Skills and qualities of a business analyst Introduction to Business Analysis in Projects Business analysis overview How organizations implement business analysis Business analyst and project manager relationships Requirements definitions and types Practice quiz On-Demand Segment A: Define the Business Problem (Pre-work for Needs Assessment) Needs Assessment Review Needs Assessment knowledge area Identify problem or opportunity Assess current and future state Determine options and provide recommendations Facilitate product roadmap development Assemble business case Practice quiz Stakeholder Engagement Review Stakeholder Engagement knowledge area Identify Stakeholders and conduct analysis Determine Stakeholder engagement and communication approach Conduct business analysis planning Practice quiz On-Demand Segment B: The Elicitation Plan (Pre-work for Elicitation) Elicitation Review Elicitation knowledge area Determine Elicitation approach Preparing for Elicitation Conducting Elicitation Confirming Elicitation results Practice quiz On-Demand Segment C: Overview of Requirements Analysis (Pre-work for Analysis) Analysis Review Analysis knowledge area Determine Analysis approach Create and analyze models Define requirements and acceptance criteria Verify, validate, and prioritize requirements Identify and analyze product risks Assess product design options Practice quiz Traceability and Monitoring Review Traceability and Monitoring knowledge area Determine Traceability and Monitoring approach Establish relationships and dependencies Select and approve requirements Make changes to requirements and other product information Practice quiz Solution Evaluation Review Solution Evaluation knowledge area Evaluate solution performance Determine solution evaluation approach Evaluate acceptance results and address defects Obtain solution acceptance for release Practice quiz Exam Application and Preparation Process Applying for the Exam Studying for the Exam Sitting for the Exam Reviewing your Knowledge Gap Practice Exam Study Guide - a reliable learning aid Summary and Next Steps Crystallizing the Business Analysis Domains Developing a Personal Action Plan for Exam Study

PMI-RMP® Exam Prep This course is aimed at preparing the participant to pass the PMI-RMP® (Risk Management Professional) exam. The course will also provide practical tips and tools that can be used in any organization's project management risk practices. In this expanded session, you will also have time to practice your exam taking skills with coaching from a credentialed instructor. The course includes the tool RMP-IQ, with sample exam questions to practice for the exam and allow participants to see their knowledge level in the various domains. What You Will Learn At the end of this course, participants will be able to: Explain the value and benefits of the PMI-RMP® credential Perform a self-assessment of your knowledge and skills Prepare a study plan that will allow you to pass the exam Foundation Concepts The Risk Management Professional (PMI-RMP®) Exam PMI's Standard for Risk Management Portfolios, Programs and Projects Key risk definitions Risk management life cycle Levels of Risk Management Enterprise Risk Management Portfolio Risk Management Program Risk Management Project Risk Management Risk Strategy and Planning: Part 1 Task 1: Perform a preliminary document analysis Task 2: Assess project environment for threats and opportunities Task 3: Confirm risk thresholds based on risk appetites Risk Strategy and Planning: Part 2 Task 4: Establish risk management strategy Task 5: Document the risk management plan Task 6: Plan and lead risk management activities with stakeholders Agile, programs, and portfolio aspects of risk strategy and planning Risk Identification: Part 1 Objectivity and bias Task 1: Conduct risk identification exercises Risk Identification: Part 2 Task 2: Examine assumption and constraint analysis Task 3: Document risk triggers and thresholds based on context / environment Task 4: Develop risk register Agile, programs, and portfolio aspects of risk identification Risk Analysis: Part 1 Task 1: Perform qualitative analysis Risk analysis in an agile environment Risk Analysis: Part 2 Task 2: Perform quantitative analysis Task 3: Identify threats and opportunities Program and portfolio aspects of risk analysis Risk Response Task 1: Plan risk responses Agile, programs, and portfolio aspects of risk response planning Task 2: Implement risk responses Monitor and Close Risks: Part 1 Task 1: Gather and analyze performance data Monitor and Close Risks: Part 2 Task 2: Monitor residual and secondary risks Task 4: Monitor project risk levels Task 3: Provide information required to update relevant project documents Agile, programs, and portfolio aspects of monitoring and closing risks

PMI-ACP® Exam Prep This course builds on the candidates' practical experience of Agile in the workplace to equip them with the broad range of knowledge and skills required for the PMI® Agile Certification exam. It will follow the PMI® requirements and reference the suggested reading list, including the Agile Practice Guide, but will not be limited to those areas. Within the profession and discipline of project management, Agile continues to develop as a significant and important aspect of bringing change to an organization. Where the products of change must be delivered to the business 'on time,' Agile is often the chosen methodology. In addition to equipping candidates for the PMI® Agile Certification examination, this course will also support candidates in taking a more informed and effective role in Agile projects. It will also enable them to take a significant role in encouraging and enabling the organization to become or develop as an Agile environment. What you will Learn You will learn how to: Appreciate the wider aspects of Agile project management tools and techniques Integrate various disciplines within Agile Tailor / customize Agile to suit the needs of different projects Prepare yourself for the PMI® Agile Certification examination Getting Started Introductions Agenda Expectations Foundation Concepts Defining 'Traditional' Project Management Project management parameters The 'traditional' approach to the parameters Strengths and weaknesses of the traditional approach Defining 'Agile' Project Management Project management parameters revisited The 'agile' approach to the parameters Strengths and weaknesses of agile Managing projects with traditional and agile methods Can the two approaches co-exist? Leveraging the benefits of both methods Options for using both methods on a project Avoiding the elephant traps Key aspects of the PMI® Agile Certified Practitioner (PMI-ACP)® Handbook Overview Eligibility requirements Exam information Exam Blueprint Continuing certification requirements Key aspects of the PMI Agile Certification Examination Content Outline Introduction Agile exam content outline Tools and techniques Knowledge and skills Domains and tasks (not examined) An Introduction to Agile and Implementing Agile Definable work vs. high-uncertainty work Project factors that influence tailoring The Agile Manifesto and 12 Principles Agile mindset Agile domains and tasks Agile Tools and Techniques Related to PM 'Hard Skills' Planning, monitoring, and adapting The need for planning, monitoring, and adapting The Agile approach to planning and plans The Agile planning tools and techniques The Agile monitoring tools and techniques The Agile approach to adapting Product quality A definition of 'product quality' Setting the standard for product quality Agile tools and techniques for achieving product quality Risk management A definition of 'risk' What is 'at risk'? The acceptability of risks The Agile tools and techniques for managing risks Agile Tools and Techniques Related to PM 'Soft Skills' The difference between PM 'hard and soft' skills Communications The importance of communications Forms of agile communications Communications within the project Communications from the project Communications to the project Making communications the cultural norm Interpersonal Skills Defining and understanding management Defining and understanding leadership Defining and understanding servant leadership Delegating vs. empowering Playing to people's strengths Overcoming the roadblocks Core Agile Tools and Techniques The philosophy of core Agile tools and techniques Agile estimation Will traditional forms of estimating work for agile? The relationship between estimating and guessing The relationship between estimating and sizing The where, who, and how of agile estimating Agile analysis and design Product analysis and design from a user point of view Product analysis and design from a supplier point of view Product analysis and design from an agile project point of view Value-Based Agile Tools and Techniques The role of value-based tools and techniques in bridging traditional PM with Agile Value-based prioritization Value-based prioritization and agile projects Investment appraisal methods Regulatory driven Customer driven Ranking methods (MMF, MoSCoW) Metrics What should we measure / track? Methods of measuring / tracking Adding value with metrics Process Improvement Value-stream analysis Value-stream mapping Agile Knowledge and Skills Context of Agile Knowledge and Skills vis-à-vis Agile Tools and Techniques Agile Knowledge and Skills Process focused People focused Product focused Project focused Exam Preparation and Course Closure The application process - where are you now? The 'Exam-Focused Journal' - what you still have to do Further preparation - self-study schedule Exam topic review Practice exam Practice exam debrief Course closure

Scrum Master Exam Prep This workshop prepares you for the Scrum.org Professional Scrum Master (PSM)™ I certification. A voucher for the exam and the access information you will need to take the exam will be provided to you via email after you have completed the course. NOTE: If you have participated in any of IIL's other Scrum workshops, you can bypass this program and focus on reading/studying the Scrum Guide and taking practice exams from Scrum.org. A Scrum Master helps project teams properly use the Scrum framework, increasing the likelihood of the project's overall success. Scrum Masters understand Scrum values, practices, and applications and provide a level of knowledge and expertise above and beyond that of typical project managers. Scrum Masters act as 'servant leaders', helping the rest of the Scrum Team work together and learn the Scrum framework. Scrum Masters also protect the team from both internal and external distractions. The Professional Scrum Master™ I (PSM I) certificate is a Scrum.org credential that enables successful candidates to demonstrate a fundamental level of Scrum mastery. PSM I credential holders will grasp Scrum as described inThe Scrum Guide™1 and recognize how those concepts can be applied. They will also share a consistent terminology and approach to Scrum with other certified professionals. What you will Learn You'll learn how to: Successfully prepare for the Scrum.org PSM I exam Comprehend the Agile Manifesto and mindset Explain the fundamental principles of Scrum, including events, artifacts, and roles Guide the Scrum team in their responsibilities Define Ready and Done Write requirements in the form of user stories Estimate using planning poker and prioritize using MoSCoW Facilitate the team through the 5 Sprint events Fulfill the role of Scrum Master in a Scrum project Create Information Radiators to enable transparency Define the structure of the retrospective Getting Started Introductions Workshop orientation Exam prep preview Foundation Concepts Agile History, Values, and Mindset Introduction to Scrum Scrum events Scrum artifacts Scrum Roles and Responsibilities Product Owner responsibilities Scrum Master responsibilities The Team responsibilities Cross-functional teams Building effective teams The Product Backlog and User Stories The Product Backlog User Stories Definition of Done Backlog grooming Estimating User Stories Story points, planning poker Prioritizing User Stories The Sprint Team capacity and velocity The Sprint Planning Meeting The Sprint Backlog The Sprint Learning to self-manage, self-organize, self-improve Sprint Review and Retrospective Project Progress and Completion The Daily Scrum The Task Board and The Burndown Chart Information Radiators Closing a Scrum Project Summary and Next Steps Review of course goals, objectives, and content Exam prep next steps