1906 Object courses in Cardiff delivered Live Online

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

Certified ScrumMaster®: In-House Training This course is an introduction to Scrum and the principles and tools required to be an effective Scrum Product Owner. You will come away with a good understanding of the Scrum framework and the underlying principles required to make effective decisions regarding the application of the Scrum framework to different situations. Participants successfully completing this course earn a Certified Scrum Product Owner® (CSPO®) designation. The Scrum Alliance certification includes a one-year membership with Scrum Alliance. What You Will Learn You'll learn how to: Use the principles, practices, and tools required to be an effective Scrum Product Owner Make effective decisions regarding the application of the Scrum framework to different situations, including: Setting product vision and goals Chartering the project Writing user stories and structuring your product backlog Scaling the Product Owner Estimating for forward planning Applying prioritization techniques Planning and tracking release progress Getting Started Introduction Course structure Course goals and objectives Agile Principles and Scrum Overview Process control models Incremental and iterative development Shifting the focus on product management Overview of the Scrum process Agile principles Lean principles Scrum Roles and Responsibilities Scrum roles Cross-functional teams Product Owner Responsibilities The Scrum Project Community What happens to my traditional role in Scrum? Chartering the Project Establishing a shared vision Elevator Statement Data sheets Product Vision Box Magazine Review / Press Release Product Backlog and User Stories Product uncertainty and progressive refinement User role modeling User Stories Product backlog characteristics Getting backlog items ready Slicing User Stories Using the product backlog to manage expectations Sprints Done and Scaling Done The Scrum process in detail Sustainable pace The Product Owner's role in each of the Scrum meetings Scaling the Product Owner Scaling Scrum Approaches to scaling the Product Owner Estimation for Forward Planning Why comparative estimation works Planning Poker Affinity Estimation Prioritization Techniques Additional Product Backlog Prioritization Techniques Kano Analysis Theme Screening Release Planning and Tracking Progress Velocity Release Planning Tracking release progress

Certified ScrumMaster®: In-House Training This course covers Scrum and the principles and tools required to be an effective ScrumMaster. You will come away with a good understanding of the Scrum framework and the underlying principles required to make effective decisions regarding the application of Scrum to different situations. At the end of the course, you will receive membership to the Scrum Alliance for two years and, following completion of an online test, will become a Scrum Alliance Certified ScrumMaster®. Our Certified Scrum Trainers pay the initial, two-year membership fee for each student who successfully completes our Certified ScrumMaster® course. This membership fee also covers the cost of the CSM Test. A link to the test will be sent to you following your course. The CSM test has a passing score of 37 out of 50 questions within a 60-minute timeframe. You will have two attempts within 90 days after you receive your welcome e-mail to pass the test at no cost. After two attempts or 90 days, you will be charged $25 for each additional attempt. What you will Learn At the end of this program, you will be able to: Provide a clear understanding of the fundamental principles of Scrum Use the principles, practices, and tools required to be an effective ScrumMaster Make effective decisions regarding the application of the Scrum framework to different situations, including: Practical, project-proven practices The essentials for getting a project off on the right foot How to write user stories and structure your product backlog How to help both new and experienced teams be more successful How to successfully scale Scrum Tips and tricks from the instructor's many years of using Scrum in a wide variety of environments Getting Started Introduction Course structure Course goals and objectives Agile Principles and Scrum Overview Agile Principles Lean Principles Process control models Incremental and Iterative development Shifting the focus on product management Overview of the Scrum process The Team Dedicated cross-functional teams T-shaped people Sprint Planning Team capacity Facilitating the Sprint Planning meeting The Sprint backlog Sprint Burndown chart Scrum Roles and Responsibilities The team and building effective teams ScrumMaster responsibilities Product Owner responsibilities The Scrum project community What happens to traditional roles in Scrum? Scrum Meetings Daily Scrum Reviews Retrospectives Product Backlog and User Stories Product backlog characteristics User stories Getting your first backlog Getting backlog items ready Slicing User stories Estimation for Forward Planning Why comparative estimation works Planning poker Affinity estimation Release Planning and Tracking Progress Velocity Release planning Tracking release progress Scaling Scrum Scrum of Scrums Scaling the product backlog Scaling across a program and business areas Distributed teams

Develop your technical report writing and presentation skills with EnergyEdge's course designed for oil & gas professionals. Sign up now!

Bunnyfoot were the pioneers and are now one of the leading providers of the Certified Professional for Usability and User Experience – Foundation Level (CPUX-F) in the United Kingdom. Created in association with the international UXQB, this professional 3-day UX certification programme covers user experience methods and theories – and is independently assessed/certified.

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

This interactive programme will use the topic of equity, diversity, and inclusion to illustrate the problem of unconscious bias and the practical solutions to overcome it. The programme will provide the opportunity for self-reflection, open discussion, and training on some of the softer skills to maximise objectivity in the workplace.

Project Estimating and Scheduling: In-House Training Establishing realistic estimates and goals for projects that support business objectives and meet client expectations is one of the most challenging aspects of project planning. Delivering those results within the agreed-upon time, cost, and quality constraints is also challenging. Attempting to meet impossible deadlines with limited budgets often leads to unplanned product shortfalls, causing long-term support and utilization problems. We have all anguished about this recurring problem, but without having the skills or knowledge to take action, we are unable to break the cycle! The goal of this course is for you to be able to support business objectives and meet client expectations by selecting the right planning approach for realistic and cost effective schedules, as well as project budgets. To achieve that, you will focus on gaining the necessary knowledge, skills, and techniques. What You Will Learn At the end of this program, you will be able to: Use the work breakdown structure (WBS) as the basis for effective estimating of project resources Estimate effort and duration using a variety of techniques Develop preliminary schedules using the critical path method Apply a variety of optimization techniques to refine preliminary schedules Establish realistic schedule and cost baselines, with appropriate contingency reserves Explain how earned value management (EVM) contributes to control time and cost performance Foundation Concepts Project management basic definitions and concepts PES Key driver: competing constraints PES Process and success factors Project Definition and the WBS Project definition overview Work Breakdown Structure (WBS) Decomposition: WBS development technique Resource Planning Resource planning overview Identifying resource requirements Identifying and filling resource gaps Applying resource planning tools Effort and Duration Estimating Estimating overview Estimating perspectives and approaches Estimating techniques Effort and duration estimating best practices Project Scheduling Overview of project scheduling Dependencies and the project network diagram Critical path method (CPM) Optimizing the schedule Budget, Risk, and Contingency Planning Overview of budget, risk, and contingency planning Estimating costs Determining the budget Project risk management processes Planning contingency reserves Project Baseline and Control Overview of project baseline Negotiating and the project baseline Earned value management (EVM) Project variances and actions Project control

Managing Complex Projects: In-House Training As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environment As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. Complex projects don't necessarily follow the rules of traditional projects - in many instances the projects' end-products, and the methods by which they will be produced, are not easily defined. Stakeholder diversity and geographical dispersion contribute to the difficulties project managers face in their efforts to gain acceptance of project goals, objectives, and changes. Additionally, hierarchic leadership styles, traditional lifecycle approaches, and traditional project manager competencies may no longer maximize the efficiencies that need to be realized on complex projects. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environments. What you Will Learn The learning objectives of this workshop are to enable participants to: Appreciate complexity and its impact on the management of projects Describe the differences among traditional, complicated, and complex projects Explain the effects of complexity on the PMBOK® Guide's process groups Apply a high-level model in the management of real- world projects Complexity and Projects Some characteristics of complex systems Important models/characteristics of complex projects Major players in project complexity Landscapes and project typologies A supplemental framework for complex projects Framing Framing overview Potential pitfalls in framing complex projects Possible solutions Inception Centrality of risk management PM competencies, selection Stakeholder identification, analysis Blueprint Collaborative planning Stakeholder engagements Alternative methodologies/life cycles Collaborative scheduling Procurement management Oversight, Navigation, and Adjustment Leadership and the project team Stakeholder management Networks Close and Continuous Improvement Transition/support Post-project evaluations Rewards/Recognition

At HFX Training, we are passionate about business simulations because they bring learning to life through hands-on experience. This Level 1 Certification Program is the first step in our Instructor Training Certification Pathway, equipping you to confidently use the Healthcare Hero simulation in your teaching environment. In this program, you will experience the simulation as a student, navigating its complexities and dynamics. Upon successfully completing Level 1, you’ll be ready to advance to Level 2 Training, where you will deepen your expertise in simulation facilitation and administration. The program is cohort-based, and the timetable is coordinated in advance through discussions with the HFX team to ensure maximum participation. For more information on the program structure, instructional materials, and certification requirements, please read on. What to Expect: The Healthcare Hero simulation places you in charge of a fictional hospital. Over eight simulation rounds - each representing one quarter of business operations - you will make strategic decisions to optimize patient care while managing staffing, capacity, quality, and finances. Throughout the simulation, you’ll navigate challenges like healthcare and economic crises, all while balancing the needs of multiple stakeholders. Your ultimate goal is to outperform competing hospitals managed by other participants in the program. Program and Certification Requirements This program equips you to confidently lead the simulation by requiring more than attendance or participation. To earn certification, you must: Thoroughly Prepare: Review all instructional materials and the scenario manual before the course begins. Fully Participate: Attend all Zoom sessions and complete each simulation round with focus and effort. Demonstrate Mastery: Show a comprehensive understanding of the simulation’s dynamics, decision-making processes, and strategies during practice and live rounds. Engage in Reflection: Actively participate in debrief sessions, assess your performance, and identify strategies for improvement. This certification ensures you are equipped to facilitate this complex simulation with confidence. Auditing the course is an option, but participants who choose to audit will not receive certification. Program Format The program is delivered intensively over one or more Zoom sessions, totaling six hours. This compressed format demands your full attention and focus to successfully navigate the simulation’s complexities. Eligibility Requirements: By registering for this training program, you acknowledge the following: You have discussed your needs with the HFX team and confirmed that the simulation aligns with your class or program objectives. You are an instructor at an academic institution. You agree to the confidentiality terms and commit not to distribute, disclose, or replicate any program content for purposes outside of this training. This program is offered in goodwill to academic instructors as a resource to enhance their teaching. As part of this agreement, you understand that all materials, including the simulation itself, are proprietary to HFX and its partners. Any use of these materials for purposes beyond this program, such as developing similar tools or simulations, is strictly prohibited. Course Structure: After registering, you will gain immediate access to the simulation’s instructional materials. This includes: The Scenario Manual: Your guide to understanding the game. The Capacity Planner Worksheet and Financial Planning Worksheet: Tools to help you strategize. The Strategy Planning Exercise: Designed to align your decisions with overall objectives. The Portal Guide: A walkthrough of the simulation platform. The program unfolds in four key phases: Phase 1: Pre Zoom Call / Study / Set Up Register using the button at the bottom of this page. Review the instructional materials thoroughly. Once the cohort is finalized, you will be sent your login credentials for the simulation itself. Try to submit decisions for the first practice round using the simulation portal at www.simulationportal.com. Phase 2: Play We run two practice rounds over the first 2 hours of the zoom call. This allows you to familiarize yourself with the platform and decision-making process, and think through what your strategy might be in the live game. The simulation resets ("zeroed") after the practice rounds. A brief session will clarify lessons learned and expectations for the live rounds. Over eight rounds, you’ll compete against other participants while refining your strategic decisions. Phase 3: Feedback Reflect on your performance during a structured debrief, including: Strengths and areas for improvement. Insights into competitors’ strategies. Strategic lessons learned, and applicability to local healthcare organizations. Phase 4: Implementation Planning Work with the HFX team to plan your first application of the simulation in a teaching environment. Certification Outcome Upon completing this program, you will earn the HFX Instructor Training Certification: Level One, signifying your expertise in conducting impactful simulation-based training using Healthcare Hero.