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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
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The YMCA qualifications support every learner, whether they are taking their first steps into fitness or simply wish to boost their skills. Course Overview Through completion of this qualification, learners will develop an awareness of mental health and be able to signpost others to mainstream medical or alternative support organisations. The purpose of this qualification is to develop learners' understanding of mental health, mental ill health and the risks associated with mental health conditions. Learners will also learn about sources of support available to individuals with mental health conditions. Endorsed by the Chartered Institute for the Management of Sport and Physical Activity (CIMSPA), this qualification can be used towards members' annual Continuous Professional Development (CPD) requirements. Enables learners to understand: • Mental health, mental ill health and mental health conditions • Attitudes to mental health • The importance of physical activity and exercise for mental health. Provides learners with knowledge of: • Risks associated with mental health conditions • Mainstream and alternative methods of supporting individuals with mental health conditions. Structure and Assessment: To achieve the YMCA Level 2 Award in Mental Health Awareness and Understanding Approaches to Support Individuals (603/7146/8), learners must successfully complete one unit. Entry Requirments Learners should be aged 16 plus No formal prerequisites, however it is recommended that learners hold YMCA Awards Level 2 Certificate in Fitness Instructing or equivalent. Progression Routes This qualification doesn't provide automatic progression onto another YMCA Awards qualification, however it may provide progression opportunities on to qualifications related to careers in mental health, health and social care, counselling or psychology. Learners taking this qualification may also consider further training at the same and higher levels in a range of qualifications. For example: • YMCA Level 2 Award in Nutrition for Healthy Living (600/5269/7). • YMCA Level 2 Certificate in Gym Instructing (603/2767/4). • YMCA Level 2Certificate in Group Exercise Instructing (603/7154/7). • YMCA Level 2 Diploma in Exercise and Fitness Instructing (Coming soon). • YMCA Level 3 Award in Emergency First Aid at Work (603/1902/1). • YMCA Level 3 Award in First Aid at Work (603/1903/3). • YMCA Level 3 Diploma in Personal Training (Practitioner) (603/2438/7). • YMCA Level 3 Diploma in Teaching Pilates (Practitioner) (603/3855/6). • YMCA Level 3 Diploma in Teaching Yoga (Practitioner) (603/3617/1). DURATION 29 Hours WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate
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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