287 Medicine courses in Middlewich

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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

When there is a shooting, stabbing or bomb explosion the initial priority will be public safety. This can delay the time before the emergency services are able to reach the injured. Our 3 hour citizenAID course enables the general public to be effective in these situations before the emergency services are available to provide professional medical support. This course can be delivered on-site or at our training centre in Poole, Dorset. -------------------------------------------------------------------------------- Qualification Information [https://www.immersemedical.co.uk/first-aid-at-work-initial#1563543325397-2de0f1af-5ca6] This qualification and learning outcomes are based on the blended recommendations of: * European Resuscitation Council, Section 9. First Aid * British Army, Battlefield Casualty Drills -------------------------------------------------------------------------------- Course Content Following this course students will: * Be able to use the citizenAID app/pocket guide in an emergency situation. * Be able to provide immediate first aid to an unresponsive casualty who is breathing. * Be able to provide first aid to a casualty with severe external bleeding. -------------------------------------------------------------------------------- Who should attend? This qualification is for all members of the public who wish to learn lifesaving skills and techniques in the event of a deliberate multiple casualty incident. -------------------------------------------------------------------------------- Pre-requisites Students must be at least 14 years old on the first day of training. -------------------------------------------------------------------------------- Assessment and Certifications Assessment of this course is continuous and will take place through knowledge and skills observations. Successful students will receive an Immerse Training Certificate, which is valid for three years. This certificate will be issued by Qualsafe, the awarding body for Immerse Training. -------------------------------------------------------------------------------- Additional Information Course fees include a copy of the citizenAID pocket guide. -------------------------------------------------------------------------------- WHAT MAKES US DIFFERENT? Fun & Engaging – Gone are the days of boring first aid training. Although professional, our trainers teach in an informal way that encourages student interaction and retention of knowledge. Technology Enhanced Learning – We utilise a range of technologies to make our courses memorable fun and effective. Bespoke Courses – Our on-site courses are designed with the specific risks of your business in mind. Training by doctors, nurses and paramedics – We have years of experience working on the front line of emergency medicine; giving us real world knowledge and skills in managing injured or unwell people.

COURSE INFORMATION Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. * Apply risk management techniques to audit planning * Plan and conduct computerised system audits * Assess system validation documentation to verify compliance * Evaluate data integrity and security issues * Prepare for regulatory inspection. THE COURSE IS STRUCTURED TO ENCOURAGE DELEGATES TO: * Discuss and develop ideas * Solve specific problems * Understand the vulnerabilities of computerised systems * Learn how to create a compliance checklist * Link system development with good business practice. IS THIS COURSE FOR YOU? * Auditors * Audit programme managers * Individuals subject to audits. -------------------------------------------------------------------------------- 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 AND INTRODUCTIONS 09:45 WHY WE VALIDATE AND REGULATORY TRENDS 10:30 BREAK 10:45 AUDIT OVERVIEW, HIGH LEVEL PROCESS AND SCHEDULING 11:30 SYSTEM LIFECYCLE 12:30 LUNCH 13:15 EXERCISE 1 - AUDIT SCHEDULING 14:45 EXERCISE 1 - FEEDBACK 15:15 BREAK 15:30 VALIDATION DELIVERABLES 16:30 RISK ASSESSMENTS 17:30 CLOSE OF DAY 1 DAY 2 09:00 SUPPLIER ASSESSMENT 10:30 BREAK 10:45 EXERCISE 2 - PLANNING A SUPPLIER AUDIT 12:00 EXERCISE 2 - FEEDBACK 12:30 LUNCH 13:15 EXERCISE 3 - AUDITING A COMPUTERISED SYSTEM VALIDATION PACKAGE 15:30 BREAK 15:45 EXERCISE 3 - FEEDBACK 16:30 CHANGE CONTROL 17:15 CLOSE OF DAY DAY 3 09:00 INFRASTRUCTURE QUALIFICATION 09:45 MAINTAINING A VALIDATED STATE - OPERATIONAL PROCESSES 11:00 BREAK 11:15 EXERCISE 4 - AUDITING SYSTEMS IN OPERATIONAL USE 12:45 LUNCH 13:30 EXERCISE 4 - FEEDBACK 14:15 EXERCISE 5 - AUDITING TRAIL REVIEW 15:30 BREAK 15:45 EXERCISE 5 - FEEDBACK 16:15 COURSE OBJECTIVES SUMMARY AND ANY ADDITIONAL QUESTIONS 16:45 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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