Explore the latest in transport tech & policy. Join our in-person workshop to gain practical insights and stay ahead in the future mobility landscape.
Enhance your knowledge in coal power plant life cycle management and flexible operations with EnergyEdge. Learn about decommissioning, preservation, repurposing, and recommissioning.
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
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
A Day in Wales. Join me for this fantastic photography workshop of woodland, lakes and waterfalls.In this course we cover all of the above. What do you need to bring with you?Camera/lenses/Spare memory card/batteries/tripod - A digital camera with "semi-automatic/manual" controls (Aperture and Shutter priority) is recommended to get the most from the course. Filters (if you have them) A packed lunch/snacks The relevant user manual for your camera Warm/waterproof clothing and suitable footwear - weather can be unpredictable all year round in Snowdonia. A notepad and pen What happens in bad weather?I monitor weather forecasts and if conditions are predicted to be completely unsuitable, to ensure both your safety and enjoyment of the day, it may be necessary to cancel a workshop. I will endeavour to provide at least 24hrs notice, although this cannot always be guaranteed; you will be offered either a full refund or a place on a future course.
This very practical workshop is designed to enable participants to improve the impact, clarity and accuracy of their business documents - both internal and external.: This workshop will help participants: Identify the purpose of writing their documents - to themselves and to their readers Recognise and meet the needs of their readers Plan documents systematically and improve the layout, flow and structure Express the content more clearly, concisely and correctly Adapt the tone and style of writing to the circumstances Proof-read and edit work effectively, using formal marks and techniques Improve visual layout, format and appearance 1 Course objectives Welcome and Introductions The problems now - group discussion 2 Writing better business documents What points to highlight / exclude Starting off Introductions Conclusions Executive summaries 3 Rules and standards George Orwell's famous maxim Why write? - clarifying your aims and objectives A seven-step method for better preparation The three-stage process for writing well Grouping information for your reader 4 Proof-reading and editing The difference between proof-reading and editing Proof-reading methods and strategies Proof-reading marks and techniques Training your eye for detail Knowing what to look for 5 Effective editing Grammar and English standards Words - usage and spelling Sentences - units of thought Paragraphs - themes Punctuation - spotting and correcting common errors Say what you mean - active v passive language 6 How's your English? Grammar quizzes and punctuation test Spotting spelling errors Rephrasing jargons and clicheÌs Common error's and mistakes 7 Document layout House style Use of white space Fonts and effects 8 One-to-one workshops These are practical sessions with one-to-one consultation with colleagues and the trainer They are held at key points to consolidate the learning from different sessions 9 Course summary Summary of key points Action plans
A 4 week intermediate pottery course at our pottery studio in Golborne, Warrington. Phoenix Pottery and Art Studio offer a variety of art, craft and pottery classes. A regular calendar of pottery courses for beginners plus pottery studio space for experienced ceramicists to work on their own projects. From Watercolour painting classes, mixed media art, wreath making, glass fusing, to Mindfulness with clay workshops and Lots of other seasonal events. All the festive classes and workshops are available to book now. Close to Warrington, Manchester , Liverpool, Wigan, Lancs and the Northwest. With easy Motorway access
Phoenix pottery and Art Studio is an Artist owned studio, offering pottery and art/craft classes in Cheshire. We have a range of pottery classes and ceramic art workshops, for beginners to experienced. We are close to the towns of Warrington, Wigan, St Helens and cities of Liverpool and Manchester . With easy motorway access from, M6 , M62 and East Lancs Rd.