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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The NVQ Level 2 Diploma in Decorative Finishing & Industrial Painting is appropriate for individuals aged 16 and over working in the construction sector who specialise in painting and decorating activity and are looking to become eligible for the Blue CSCS Card. The aim of this qualification is to recognise the knowledge, skills and competence of individuals who specialise in painting and decorating activity. Upon completion of the qualification, you will be awarded the NVQ Level 2 Diploma in Decorative Finishing & Industrial Painting. CSCS Cards We can provide CSCS tests and CSCS Cards alongside the qualifications without the need to attend the test centre. Speak with our friendly and helpful team for more information.
Where should management effort be directed? In controlling costs and ensuring proper engineering in live projects? - yes, of course, but true cost control comes by understanding, eliminating and minimising risk prior to a business committing any funds. This course studies the stages required for practical financial and business appraisals of projects and capital expenditure. This course has two primary objectives: To impart the knowledge and skills required to ensure as risk-free as possible expenditure of that scarce resource, cash - the investors', governments' or shareholders' money must not be squandered To improve the quality of the appraisal process in the widest sense - demonstrating how the process of project and capital expenditure appraisal can be used to dramatically improve cost control and deliver as risk-free as possible expenditure As a result of the course, participants will be able to: Understand the economics of appraisal Be in control of their projects from the start Understand the economics of their projects - and devise the most appropriate mode Carry out sensitivity analysis and identify risk Improve their methods of appraisal and approach Focus on the risk areas and take out risk and control costs before they over-run The benefits of attending this course will be demonstrable from day one. Thorough appraisals and risk assessment follow through to success in project management and detailed cost control and project management. 1 Introduction Why appraise? Taking risk out of investment The short- and long-term results of not appraising business expenditure 2 Developing an appraisal process The process - overall and stage-by-stage objectives Understand business and technical risks Manage resources and time Do you invest enough time and effort at this stage? Take out the risks - control costs before you are committed to contracts and action Checklists 3 Appraisal arithmetic Review of the arithmetic of appraisalThe time value of moneyThe effects of different interest or required ratesThe effects of inflation (or deflation) in prices and costs Understanding the economics of appraisal is essential 4 Appraisal measures Meaning and use of appraisal measures Identifying the most appropriate measures for your particular business Payback Discounted cash flow measures - NPV and IRR Other measures - FW, AW, Profitability Index The meaning of the measures and their application in practice 5 Cost benefit analysis The effect on decision-making of more intangible benefits Cost benefit analysis Ensuring costs are genuine Measuring intangible benefits Environmental issues Consideration of intangible benefits in the appraisal decision-making process 6 Developing appropriate models Developing models - examples of spreadsheet models and measures for many different situations Modelling investment opportunities - summarising outcomes Sensitivity analysis - identifying, quantifying and taking out risk 7 Developing an appraisal process The process - managing risk from the outset Using the process in risk management, negotiating and project management Take out risk by thoroughly knowing your project - developing your own process
Aimed at owners who have either attended one of our Level One Courses or have a good understanding of how an aircooled vehicle works and want to learn more about maintaining their vehicle. ADVANCED AIRCOOLED MAINTENANCE Workshop objective: To give you the knowledge and confidence to carry out routine maintenance on your aircooled vehicle. Workshop Contents: Morning (All Hands On) Electrical Fault Finding Right Tools for the Job Basic Electrical Checks Tracing Faults Engine Tuning Manual Timing Using Strobe Timing Gun Carb tuning After Lunch (All Hands On) Braking Systems Brake Adjusting (different types) Brake Bleeding Steering Systems Checking and adjusting Full notes supplied to support course
Aimed at owners & potential owners wanting to learn more about the vehicle they drive and how to look after it. INTRODUCTION TO AIRCOOLED Vehicles Workshop objective: To give you the knowledge and confidence to successfully look after your aircooled vehicle. Workshop Contents: Morning How an air-cooled engine works How to get the best out of your engine What can go wrong and how to prevent them from happening Key things you need to know about an MOT Key things on keeping you, your passengers safe. After Lunch (Hands On) How to maintain your aircooled vehicle Adjusting points, timing and valve clearances Changing Oil & Strainer Changing Spark Plugs Changing the fan belt Carrying spares to help breakdown services getting you back home safely Further reading and learning more