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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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We have expanded our asbestos awareness courses to specifically cover the awareness of asbestos in soils, made-ground and construction and demolition materials. Essential for geotechnical engineers, plant operators, civil engineering contractors and ground workers. The content of this course is designed to provide anyone whose work could foreseeably expose them to asbestos with sufficient knowledge to avoid putting themselves or others at risk, in line with regulatory requirements laid out in Control of Asbestos Regulations 2012, and specifically for those working on land with potential asbestos-contamination.

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Highfield Level 1 Award In Health And Safety Within A Construction Environment (RQF) Highfield Level 1 Award in Health and Safety within a Construction Environment (RQF) One day course For those applying for the Green Labourer CSCS Card Includes the Health, Safety, Environment Test For Operatives and Specialists book or DVD by CITB! Face to Face: One day course + time for self-study required This course is supported by the Construction Industry Training Board (CITB) This course is designed to give learners a route to applying for the Green Labourer CSCS Card Course Contents: The purpose of a risk assessment The purpose of a method statement The legal requirements of risk assessments and method statements The common causes of work-related fatalities and injuries The implications of not preventing accidents and ill-health at work Health and safety definitions Hazards and potential risks of a a range of situations The importance of reporting accidents and near misses Accident reporting procedures Risk assessments and dynamic risk assessments The reasons for using safe manual handling in the workplace The employees' responsibilities under current legislation and official guidance in relation to manual handling in the workplace The procedures for safe manual handling Working at height Employees' legal responsibilities in relation to working at height Potential hazards when working at height Controlling risks and hazards while working at height Regulations regarding working at height COSHH: substances hazardous to health Common risks to health within a construction environment Drugs and alcohol Personal Hygiene Asbestos PPE (Personal Protective Equipment) Working around plant and equipment safely Benefits of this course: In 2018/19, 1.4 million people suffered from a work-related illness They have a much higher rate of work-related ill-health than those working in many other industries Construction workers have the highest rate of musculoskeletal disorders compared to other occupations This course develops learners’ knowledge and understanding of health and safety in a construction environment so they can work safely on a construction site Those who successfully complete this Level 1 Award in Health and Safety in a Construction Environment and have completed the CITB Health, Safety & Environment Test within the last 2 years can then apply for a Green Labourer CSCS card. Our Health And Safety In A Construction Environment Training Course is a nationally recognised, Ofqual regulated qualification accredited by Highfields Qualifications.This course leads to the obtainment of the CSCS labour card, allowing workers to work on construction sites.The Ofqual Register number for this course is 603/2442/9

For higher risk or larger workplaces/organisations such as engineering, factories, restaurants, warehousing, construction or for those who use chemicals. This is also the appropriate course for larger low risk workplaces or workplaces who have employees with medical conditions. No previous experience required HSE Compliant Certificate valid for 3 years Taught by experienced trainers Interactive & engaging delivery techniques All age groups covered (adults, children & infants) All learners will have the skills and knowledge to provide the organisation with First Aider’s that can provide treatment to their casualties in a prompt, safe and effective manner. Duration FAW Initial - 18 hours (2 days face to face + 6hrs of elearning) RFAW Requal - 12 hours (2 days face to face, with a valid previous certificate) Syllabus A range of subjects are covered including: Day 1 Role of the First Aider Primary Survey Unresponsive (Breathing) - Recovery Position & Monitoring Unresponsive (Not-Breathing) - CPR & AED Bleeding (Catesrophic, Severe & Minor) Burns Choking Seizures Shock Day 2 Fractures, dislocations and spinal injuries Poisoning Heart attacks Head injuries Chest injuries Asthma Stroke Shock Severe Allergic Reaction Eye injuries Sprains and strains Diabetes Day 3 (elearning) For those who are completing the qualification for the first time or do not have a valid existing certificate, will be required to complete elearning, which can be done before the training or within 30 days after the training. Those re-qualifying, need not complete the elearning. Assessment Continual assessment is used, combined with a number of observed practical activities and 3 short theoretical assessments, supported by our experienced trainers. Instructions Please ensure that this is shared with those who are attending the course Thank you for booking with Certifi Training, we are looking forward to having you on our course. You must bring a form of Photo ID to your training. This can be a passport, driving licence, government issued biometric card, rail card, Police Warrant Card or Official Work ID. Please arrive in good time for your training (we advise 15 mins before the start time). Late learners will not be accepted and will turned away without refund. Please wear clothing suitable for practical activities (no skirts or high heels). You must attend the entire course, learners who leave early will not be issued a certificate. Covid-19 - due to this being a healthcare course, you are prohibited from attending if you have contracted Covid-19. Practical Elements - in order to pass the course, you will be required to kneel down on the floor (primary survey), be rolled onto your side (recovery position) and perform 2 mins of rescue breaths and chest compressions (CPR). This will all have to be completed unaided. Cancellation and Postponement - our policy is found here (https://bookwhen.com/certifitraining/page/refund_policy) Injuries & Medical Conditions - if you have an injury or medical condition which would prevent you from performing practical activities, this may prevent us from being able to issue you with a qualification, please contact us if concerned. Allergies & Sensitivities - if you have an allergy or sesitivity towards hand santizers or cleaning products, please let your trainer know. Our equipment is latex free. Pregnancy - Please alert your trainer if you are or maybe pregnant. It will not stop you from being able to participate in the course, however your trainer will make a couple of adaptions during recovery position and choking activities. Reading & Writing - you must be able to read and write in English, however this can be supported by your trainer if you have a learning need (such as dyslexia) or English is your 2nd language. Certificates - certificates will be issued to the person who booked your course if you pass the course criteria. Certificates are in PDF format and will be issued within 2 weeks of the course. Elearning Certain Courses will be required to complete elearning, which can be done 30 days before or after the training, however it is beneficial if... [Read more]

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