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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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What you Will Learn Plan and prioritize each day's activities in a more efficient, productive manner Establish strategies to execute priorities and overcome procrastination Understand how to make trade-offs when faced with fire drills How to set and communicate boundary conditions Getting Started Introductions Course orientation Participants' expectations Foundation Concepts Exercise: A day in your life Resources to implement change Mind-set Tool-set Skill-set What is your time really worth? The dynamics of procrastination The myth of multi-tasking Brain Rules - how to optimize your efficiency Organization and Prioritization Time management best practices Goal setting Exercise: Identifying your priorities The importance of organization Time management framework Prioritizing time Time Management Techniques Tips for managing time Nine ways to overcome procrastination The STING technique Managing your time o Handling unplanned urgencies o Dealing with information overload Delegation and managing others' time Creating your personal action plan Summary Course summary and next steps Applying what you have learned

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BTST Academy are proud to host this amazing 1x day manual therapy CPD course covering patient assessment, treatment and rehabilitation for the Shoulder with Osteopath Becky Tyler and in association with Rehab my Patient Focusing on anatomy and biomechanics of the shoulder in order to enable the therapist to fully grasp the concept and mechanism of the most common injuries and dysfunctions seen in clinic. Critical factors related to each joint pathophysiology including injury repair and healing time will also be addressed along with proven strategies of treatment and exercise rehabilitation prescription to enable you as the therapist to feel confident in all aspects of your patients treatment. The process of examination, evaluation, diagnosis & prognosis for disorders of the shoulder will be explored in detail with a nice mix of Theory and Practical delivery. Venue BTST Academy & Clinic, Holly Farm, Clipstone Road, Edwinstowe, Nottingham, NG21 9JD Course Price £175 Tutor Becky Tyler BOst, PGCertSPOP, DipSMT Conditions covered: Common injuries and dysfunctions covered include; Shoulder Impingement ACJ Osteoarthritis Rotator Cuff Pathologies Frozen Shoulder Dislocations Labral Tear Biceps Tendinopathy ACJ Separation And more Rehab Exercises; During the course a 5x step approach to rehabilitation will be covered with example exercises to help you get your patients moving again. T&Cs Deposit: Payment in full required at time of booking Entrance requirements: Must be a qualified manual therapist such as an; Osteopath, Physiotherapist, Chiropractor, Sports Therapist, Sports Massage Therapist Etc. We may ask you to provide a copy of your qualification. Course Terms & Conditions & Cancellation Policy Click here for the terms and conditions.