Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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 19 Points Development Level Develop
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Looking for a running club that’s more about good vibes and deep conversations than chasing personal bests? Welcome to the Numinity Running Club! We’re redefining the run club experience, blending mindfulness with movement to create an inclusive and supportive community of runners. What to Expect: Join us every Sunday for a refreshing run through the scenic paths of Hampstead Heath, one of London’s most beautiful green spaces. Our flexible route offers both 5k and 10k options, perfect whether you're just starting out or a more seasoned runner. No matter your pace, you're welcome. Details: Bag Drop: 11am drop your bag at our favorite local spot, Never for Ever. Run Start: 11.15am sharp – we hit the pavement together! Route: We’ll guide you through the lush landscapes of Hampstead Heath, offering a mix of beautiful trails. Post-Run: Unwind with us back at Never for Ever for a well-deserved bite to eat and to connect with like-minded souls. Why Join? Mindful Movement: Experience running as a way to clear your mind, connect with others, and embrace the present moment. Great Company: Meet new people who value connection over competition. Flexible Distance: Choose between a 5k or 10k route – whatever your body needs. Hampstead Heath: Enjoy the natural beauty of this iconic London park. Post-Run Social: Stick around after the run at Never for Ever for some delicious food, drinks, and good conversation. How to Prepare: Wear comfortable running gear and don’t forget your water bottle. Arrive at Never for Ever from 11am to drop your bag and get settled. We’ll start at 11:15am sharp. Come for the run, stay for the community. See you on Sunday! Let's Connect: Join our Whatsapp Group to connect with the community. Follow us on Instagram
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Join Sherien from "Let Go" for an immersive FREE Breathwork Class designed to empower you through the art of mindful breathing! In this class, you'll discover how to use your breath to support better physical health, reduce stress, and enhance mental clarity. Whether you're looking to improve your energy levels, sleep patterns, or simply want to feel more balanced and centered, these breathing techniques can bring profound benefits This class offers you the chance to: - Learn breathwork methods that improve oxygen flow and boost vitality. - Reduce tension and anxiety through guided breathing exercises. - Experience greater focus, emotional balance, and relaxation. - Connect with a supportive community in a calm, nurturing environment. No prior experience is necessary—just come with an open heart and a willingness to breathe deeply and let go. Don't miss this transformative opportunity! Reserve your FREE spot today and take a step towards improved well-being and self-awareness. This class is sponsored by The Volant Charitable Trust Small Grants Programme, administered by Foundation Scotland. It is FREE and is aimed at WOMEN only from ETHNIC MINORITY BACKGROUNDS living in Edinburgh as per this funding application . This means “international”, from every foreign country. (Irish, any other white background, mixed ethnic, Asian/Asian British, Black/African/Caribbean, Black British, Arabic or other ethic groups) However we do welcome locals too so just sign up. We prioritize the area of Gorgie-Dalry-Saughton where our studio is based. By attending this class you release the teacher, Giada Gaslini and Art and Spirituality Cic, from any liability arising out of any personal injuries, emotional or physical release, death, expectations of results, theft in the venue or damages that may happen to people and objects while attending.