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
Develop a deep understanding of electricity pricing and marginal cost analysis with EnergyEdge's virtual instructor-led training course. Enroll now for a rewarding learning journey!
Data Ethics for Business Professionals is designed for individuals who are seeking to demonstrate an understanding of the ethical uses of data in business settings.
A half day course for those who find themselves taking and presenting minutes for different kinds of meetings. The session will provide practical tips on how to write minutes that are clear and more concise and how to save time during the minute-taking process. It will be a useful session for both novice and experienced minute takers.
The importance of building services to the success of an organisation has never been greater and continues to grow. Developers and occupiers are becoming more aware of the contribution that building services make to the well being of occupants and hence their perception of the quality of the working environment. Those involved with the design, construction, maintenance and operation will increasingly be required to deliver building services that demonstrable contribution to the occupier's business. Energy efficiency, carbon management and occupant satisfaction depend substantially on the way building services are designed, managed and operated. To optimise these aspects, an informed strategic approach is essential. Tried and tested techniques and processes are available that, when applied holistically, will deliver substantial benefits. This course reviews best practice in the area and inspires participants to ensure that building services perform at their optimal level. To provide a better understanding of how building services can be designed, managed and operated to: Maximise occupant comfort, satisfaction and wellbeing Add value and contribute to the success of the business of the occupier Improve health safety Reduce operating cost, energy use, carbon emissions and environmental impact Optimise cost and value Provide strategies for continuous improvement and sustainable operation 1 Building services fundamentals The function of services in commercial buildings and their importance to the core business 2 Techniques and processes for optimising cost and value Programmed operation evaluation Continuous commissioning Lifetime product management Performance-based service Energy efficiency and the scope for environmental improvement 3 Making the business case and preparing the strategy Motivating decision-makers Empowering those who have to deliver the results Managing business risk 4 Strategy implementation and monitoring results Ensuring that rich and robust feedback is available to support continuous improvement and strategy enhancementWhen to get feedbackWhyHowWhat to do with it 5 Case histories and 'air time' Sharing experience and addressing specific issues of interest to participants Course review Close
Join us for some Mindfulness as part of our Therapeutic Arts Series of workshops. Our wonderful glass Artist Debs will guide you in relaxation, mindful practise and will encourage you to engage your creative flow. With demonstration and guidance you will complete a fused glass and enamel mandala design. The finished piece can be an art display or coaster. During these sessions we utilise Aromatherapy, gentle music and relaxation techniques to help us to engage in quiet peaceful making. We discourage chatter to allow for full immersion in the process. All workshop facilitators in this series are Therapeutic Arts Practitioners. This workshop is in the fully accessible area of our studio.
We deliver Workplace PAT Testing Courses across most of the UK to assist businesses with Compliance. We also work with Bridges into Work and ReACT in association with Careers Wales and the Welsh Government to offer work based skills which some Candidates could be eligible for Government funding.
IPAF training is the most widely recognised standard for Mobile Elevated Work Platform operators. These are commonly known as MEWP’s or Scissor Lifts and Cherry Pickers. MHA Training is a fully approved and registered IPAF member and we can deliver a wide range of courses. This can be done at our training centre in Warrington or On-Site at customer premises Nationwide. The International Powered Access Federation (IPAF) promotes the safe and effective use of powered access worldwide. Set up in 1983, IPAF is a non-profit organisation that represents the interests of member training companies. Over the years, IPAF has played a key role in promoting many of the design safety and testing procedures that are now established in the powered access industry. Companies such as MHA Training in Warrington are responsible for training for over 90,000 operators each year. Those who successfully complete their training at our centre in Warrington, or out On-Site nationwide are awarded the PAL Smart card. The (Powered Access Licence) is the most widely held and recognised qualification for mobile platform operators. The PAL Smart card is valid for five years and shows the machine categories that an operator has been trained on. It also features the holders photo and signature, and can be verified on their website. IPAF itself does not provide any training, it is provided by approved quality training centres like MHA Training. Approved training centres are regularly audited by IPAF, which ensures the highest standards are consistently met. Class sizes are kept small and courses generally last 1-2 days and are a mixture of theory and practical. To ensure success candidates must then undergo a 30 question multiple choice paper and a practical test. Course material is available in many languages and training centre’s receive regular updates. MHA Training was established in 2008 based at our training centre in Warrington, Cheshire. We provide an array of services On-Site also for clients around the North West in areas such as Manchester, Liverpool, Widnes, St. Helens, Runcorn, Wigan, Preston and Leeds. Over the years we have expanded and have instructors available Nationwide. IPAF E-Learning. IPAF’s new E-learning module is part of its full training programme for mobile elevating work platforms (MEWPs). The E-learning module delivers flexibility and interactive tools, with the same emphasis on practical training. Together with supervised written and practical testing of operator skills. E-learning can lead to a PAL Card (Powered Access Licence) which proves that the operator has successfully completed the training and is able to operate MEWP’s safely. Benefits: Flexible. Trainees complete the theory part anytime, anywhere, on any device, at their own pace. Interactive. Engages trainees with games, quizzes, videos and simulations. Operator E-learning does not replace practical training. Trainees who complete the online session must still pass a supervised theory test with an IPAF centre like MHA training. Also must successfully complete a minimum half-day of practical training and testing before being issued a PAL Card as proof of successfully completed operator training. Training Courses Available: Operators. Demonstrators. Static Boom (1b). Mobile Vertical (3a). Mobile Boom (3b). Push Around Vertical (PAV). Other courses: Harness Use and Inspection (H).
Immerse Training is a fully regulated First Aid Training Provider. We love working in schools, nurseries and youth groups teaching young people how to keep each other safe and what to do if something goes wrong. With sessions sessions from 1 hour tasters for every class in a school, to after school first aid clubs, Immerse Training are certain to design a programme that’s right for you, your budget and your children. We currently deliver First Aid and Life-Saving skills across a variety of settings to groups of children and young people from 4 to 14 years old, when they are able to participate in accredited First Aid courses. All of our First Aid Training for Children courses are designed in collaboration with qualified childcare practitioners and child health clinicians. Our programmes can be tailored to meet any area of the curriculum from Early Years Foundation Stage through to Key Stage 3. First Aid Training for Children is a great way to prepare young people for specific activities such as Duke of Edinburgh expeditions, babysitting and sports leadership. First Aid Courses For Young People Programmes and sessions for young people focusing on how to keep each other safe and what to do if something goes wrong. Sessions are designed with age and national curriculum in mind, from 1 hour tasters to sessions for large groups, perfect as part of NCS and Duke of Edinburgh programmes. Our training for young people is fun, engaging and focuses on fundamental life saving skills. All courses can be delivered at our training centre in Poole, Dorset or we can deliver on-site across Bournemouth, Poole, Dorset, Hampshire and the South of England.
A relaxed and informal Blackwork Embroidery course in the lovely setting of a converted 18th Century cotton mill in Warwick Bridge, Carlisle. This course has been designed to guide the complete beginner or act as a refresher for those who may have dabbled in Blackwork embroidery in the past. We will cover the history, styles of Blackwork embroidery, threads and techniques.