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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
Microsoft Project Orange Belt® 2013 This workshop gives participants a full insight into creating effective schedules using Microsoft® Project 2013, allowing you to estimate, coordinate, budget, staff, and control projects and support other users. This workshop gives participants a full insight into creating effective schedules using Microsoft® Project 2013, allowing you to estimate, coordinate, budget, staff, and control projects and support other users. This workshop provides the eBook Dynamic Scheduling with Microsoft® Project 2013, and is kept up to date with the framework of knowledge outlined by the Project Management Institute's PMBOK® Guide and the Practice Standard for Scheduling. What you Will Learn You'll learn how to: Understand what's new in Project 2013 Explain where Project 2013 fits in the Microsoft® EPM solution Initialize Project 2013 to start project planning Create a well-formed project schedule Understand task types and the schedule formula Assign resources and costs to tasks Analyze resource utilization and optimize the schedule Set a baseline and track progress Create and manage project reports Customize views and fields Apply Earned Value Management Understand the basics of managing multiple projects Getting Started Introductions Course structure Course goals and objectives Enterprise Project Management Concepts and Framework Getting Started with Project 2013 Project 2013: What's New and General Overview Setting Up a New Project Schedule (templates, options, save, etc.) Setting the Project Calendar Entering Tasks The Planning Processes Importing Tasks (Word, Excel, SharePoint) Synchronizing with SharePoint Tasks List Creating and managing the WBS (include tasks, manually scheduled tasks, summary tasks and milestones, as well as custom WBS coding) Entering Estimates Tendencies in Estimating The Rolling Wave Approach Entering Duration and Work Estimates Types of Tasks Entering Dependencies The Principle of Dynamic Scheduling Choosing the Right Type of Dependency Entering Dependencies in Project 2013 Different Applications of Dependencies Entering Deadlines, Constraints, and Task Calendars Use of Deadlines and Constraints Entering Deadlines and Constraints in Project 2013 Entering Resources and Costs Types of Resources Entering Resources in Project 2013 Calendars and Resources Entering Costs in Project 2013 Entering Assignments Assignments in a Schedule Assignments and Task Types Entering Assignments in Project 2013 Assignments, Budgets, and Costs Optimizing the Schedule The Critical Path Method and the Resource Critical Path Resource Leveling Optimizing Time, Cost, and Resources in Project 2013 Updating the Schedule The Baseline Updating Strategies and Situations Prepare the Status and Forecast Report in Project 2013 Reporting Using Reports Using Visual Reports Formatting and Printing in Project 2013 Customizing Fields in Project 2013 Earned Value Management (EVM) Overview of EVM Applying EVM with Project 2013 Evaluating the Project Evaluating the Project Performance Project Benefits and Results Templates for Future Projects Summary Tools and Checklist Best Practices Checklist Consolidated Schedules Creating Consolidated Schedules Using a Resource Pool Links across Projects Solving common problems Analyzing the Critical Path across Projects
Microsoft Project Orange Belt® 2013: In-House Training This workshop gives participants a full insight into creating effective schedules using Microsoft® Project 2013, allowing you to estimate, coordinate, budget, staff, and control projects and support other users. This workshop gives participants a full insight into creating effective schedules using Microsoft® Project 2013, allowing you to estimate, coordinate, budget, staff, and control projects and support other users. This workshop provides the eBook Dynamic Scheduling with Microsoft® Project 2013, and is kept up to date with the framework of knowledge outlined by the Project Management Institute's PMBOK® Guide and the Practice Standard for Scheduling. What you Will Learn You'll learn how to: Understand what's new in Project 2013 Explain where Project 2013 fits in the Microsoft® EPM solution Initialize Project 2013 to start project planning Create a well-formed project schedule Understand task types and the schedule formula Assign resources and costs to tasks Analyze resource utilization and optimize the schedule Set a baseline and track progress Create and manage project reports Customize views and fields Apply Earned Value Management Understand the basics of managing multiple projects Getting Started Introductions Course structure Course goals and objectives Enterprise Project Management Concepts and Framework Getting Started with Project 2013 Project 2013: What's New and General Overview Setting Up a New Project Schedule (templates, options, save, etc.) Setting the Project Calendar Entering Tasks The Planning Processes Importing Tasks (Word, Excel, SharePoint) Synchronizing with SharePoint Tasks List Creating and managing the WBS (include tasks, manually scheduled tasks, summary tasks and milestones, as well as custom WBS coding) Entering Estimates Tendencies in Estimating The Rolling Wave Approach Entering Duration and Work Estimates Types of Tasks Entering Dependencies The Principle of Dynamic Scheduling Choosing the Right Type of Dependency Entering Dependencies in Project 2013 Different Applications of Dependencies Entering Deadlines, Constraints, and Task Calendars Use of Deadlines and Constraints Entering Deadlines and Constraints in Project 2013 Entering Resources and Costs Types of Resources Entering Resources in Project 2013 Calendars and Resources Entering Costs in Project 2013 Entering Assignments Assignments in a Schedule Assignments and Task Types Entering Assignments in Project 2013 Assignments, Budgets, and Costs Optimizing the Schedule The Critical Path Method and the Resource Critical Path Resource Leveling Optimizing Time, Cost, and Resources in Project 2013 Updating the Schedule The Baseline Updating Strategies and Situations Prepare the Status and Forecast Report in Project 2013 Reporting Using Reports Using Visual Reports Formatting and Printing in Project 2013 Customizing Fields in Project 2013 Earned Value Management (EVM) Overview of EVM Applying EVM with Project 2013 Evaluating the Project Evaluating the Project Performance Project Benefits and Results Templates for Future Projects Summary Tools and Checklist Best Practices Checklist Consolidated Schedules Creating Consolidated Schedules Using a Resource Pool Links across Projects Solving common problems Analyzing the Critical Path across Projects
Assuring Quality Through Acceptance Testing: Virtual 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?
This beginner-friendly course takes us on a journey into data visualization. You will learn to transform raw data into stunning visuals using Matplotlib, Seaborn, and Plotly. From charts to dynamic heatmaps, we will master the essentials. Fuel your curiosity, enhance your skills, and communicate insights effectively to become a Python data visualization pro!
This is a hands-on course that comes packed with source code ready for you to use through the lessons. The objective of this course is to guide you through the essentials of HTML5 Canvas drawing and how it works. You must have prior coding experience in JavaScript and HTML and familiarity with web development before getting started with this course.
A payment plan is available, please contact us for more details. WSET Level 3 in Wines Award is an advanced level qualification for professionals working in the wine industry and for wine enthusiasts. If you are looking to delve deeper into the world of wines, this qualification provides a detailed understanding of grape growing and wine making. Upon completion you will be able to assess wines accurately, and use your understanding to confidently explain wine style and quality. What the course covers Wine Tasting: Taste, describe and analyse wines using the WSET Systematic Approach to Tasting Food and Wine Matching: A guide to the key considerations when matching food and wine successfully Labelling: Learn how to decode and understand labels Wine Production: Learn about the production factors influencing the style, quality and price of wine from vineyard to bottling Light Wines: Learn about the styles of wines produced in the key wine regions and districts of the world: France, Italy, Spain, Portugal, Austria, Germany, Greece, South Africa, Australia, New Zealand, North and South America, England and Wales Sparkling Wines: Learn about the methods of production and the main styles of sparkling wines from the key wine producing countries: France, Spain, Italy, Germany, New World - Australia, California, New Zealand, South Africa Fortified Wines: Learn about the methods of production/main styles of fortified wines from the key wine countries: Spain, Portugal, France, Australia Examination: The examination is in two parts and takes place in the afternoon session of the final day of the course. The WSET Exam fee is included in the course cost. Theory paper: a combined theory paper consisting of a 50 question multiple-choice section and a four question short answer written section. 2 hours. Tasting: a blind tasting of two wines. A mark of 55% required in all sections to pass. 1 hour. The qualification has full accreditation from the UK Government’s Qualifications & Curriculum Authority as a Level 3 Vocational Qualification. To view the full course specification, including examples of exam questions, please click HERE. Recommended Private Study: 56 hours additional private study is recommended for this course. It is strongly recommended the majority of the private study is done in preparation for each session. Private study is essential to ensure that you are ready and prepared for the exam. Entry requirements: Although not essential, we do recommend you have completed the WSET Level 2 Award in Wines before enrolling on the course. The syllabus assumes that candidates already possess a good basic understanding of simple wine making techniques, key grape varieties and viticultural patterns. The fee of £825 includes All WSET course materials including; 'Accounting For Style And Quality' course manual (comprehensive 250 page textbook), Study Guide and Full SAT Tasting Card All wine tasting samples (60 to 70 wines) The use of professional ISO tasting glasses 6 days of professional WSET tuition by a WSET Certified tutor Teaching of the WSET Level 3 Systematic Approach to Tasting Wine (SAT) ® which will enable you to analyse wines objectively and consistently in preparation for the tasting exam Two fully marked mock tasting exams and weekly written exam technique sessions to ensure you are fully prepared for the exam Comprehensive student support by WSET certified educator outside of class time should you have any questions before, during and after the course Registration with WSET and all examination fees Internationally-recognised certificate and pin badge upon successful completion VAT at 20% (VAT receipt can be provided on request) Special Educational Needs Please make us aware if you have a condition that may mean you qualify for additional help during the exam such as dyslexia. Funding Funding for this course is available: DEVELOP is the educational programme of The Drinks Trust, the drinks and hospitality industry charity. DEVELOP offers fully funded training and skills courses, delivered by industry-leading providers for people already working, or with an ambition to work, in the drinks and hospitality industry. Manchester Wine SChool has partnered with The Drinks Trust to bring courses free of charge to eligible students. All of the WSET courses are available for funding with DEVELOP. To learn more please visit the Drinks Trust website HERE Criteria of eligibility for DEVELOP funding: must be 18 or over, eligible to work in the UK, have a National Insurance Number, and be earning less than £26k/pa
In this course we explore Mental Health and address how such needs can be met in mainstream classrooms. Course Category Behaviour and Relationships Meeting Emotional Needs Description This is our lead workshop/training day on understanding mental health, behaviour and relationship work in schools other settings and is both a values primer and a practical guide to successful innovative strategies for improving behaviour and strengthening relationships for challenging children and young people of all ages. Not just another day on ‘Behaviour Management’ – Our Mental Health Day goes well beyond a rewards and sanctions approach to ‘behaviour’. We will be focused on those young people for whom rewards and punishments do not always work and who confuse the adults who work with them. We aim to take a relationships-based approach and to give those attending an opportunity to think more deeply about why young people do the things they do and what our part as adults is in creating, sustaining and changing these behaviours. The day gives those present opportunities to reflect on their attitudes and practice in relation to children’s behaviour and relationship building. If your usual approaches to managing tackling mental health needs aren’t working with particular individuals then take a tour through this range of cutting edge strategies for bringing about positive behaviour change, and for meeting challenging emotional needs Learning Objectives reinforce and affirm good practice re-energise, stimulate and challenge thinking about inclusion of challenging pupils and children increased understanding of mental health increased confidence in managing challenging pupils in mainstream schools access to a wider range of practical strategies to impact on behaviour problems opportunity to reflect on professional attitudes and behaviour towards mental health in families and pupils Who Is It For ? Anyone concerned with understanding and meeting emotional and mental health needs Course Content Circle of Courage – belonging-achievement-generosity – independence – model for understanding mental health Compass of Anxiety – understanding and going deeper Active listening – Listening to the person underneath the behaviour Involving other children and young people in solutions and interventions - Circles of friends: peer support, counselling and mediation Team Problem Solving – Solution Circles: a 30 minute group problem solving process to get Teams ‘unstuck’ and to generate positive first action steps Restorative justice and restitution: principles and practice of this approach to repairing harm and restoring relationships without reliance on punishment Understanding the effects of Separation, Loss, Trauma and Neglect on children’s learning and relationships in school and what adults can do to reach and support these children