2802 Courses in Lymm

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

About this Virtual Instructor Led Training (VILT)  Electrification of the transportation sector will impact the power system in several ways. Besides the additional load, local impact on the grid needs to be managed by the grid operators. Simultaneously charging of many electric vehicles (EVs) might exceed the limits in specific locations. On the other hand, EVs can provide flexibility and other ancillary services that will help grid operators. This 3 half-day VILT course will provide a complete overview of integrating electric vehicles (EVs) into the power grid. It will cover the whole value chain from grid operations to the car battery. This includes the control room, possible grid reinforcement, demand side management and power electronics. This course will demonstrate the impact on the grid and solutions for a safe & cost-effective grid plan and operation, with examples of successful integration of EVs. The course will also provide vital knowledge about technology used for EVs such as power electronics, demand side management, communication and batteries. In this context, the focus will be on power electronics as it has the highest impact on the grid. The grid planning tool, pandapower, is introduced as an open source tool for power system modelling. The set-up of the training course allows for discussion and questions. Questions can be formulated by the participants upfront or during the training. This course is delivered in partnership with Fraunhofer IEE. Training Objectives At the end of this course, the participants will: Understand the charging options for EVs and its impact on the grid and batteries Identify system services for EVs with regards to voltage quality at the point of common coupling Discover what are the 'grid friendly' and grid supporting functions in EVs Uncover the different applications, standards and data researched on EVs Examine the application of a grid planning tool (pandapower) for power system modelling Be able to develop code snippets with pandapower Apply and execute a code example for power system modelling with pandapower Target Audience EV and grid project developers and administrators Power grid operators and planners EPC organisations involved in grid development EV/ battery manufacturers and designers EV transport planners and designers Government regulators and policy makers Training Methods The VILT will be delivered online in 3 half-day sessions comprising 4 hours per day, with 2 x 10 minutes breaks per day, including time for lectures, discussion, quizzes and short interactive exercises. Additionally, some self-study will be requested. Participants are invited but not obliged to bring a short presentation (10 mins max) on a practical problem they encountered in their work. This will then be explained and discussed during the VILT. A short test or quiz will be held at the end of every session/day. Trainer Our first course expert is Head of Department Converters and Electrical Drive Systems at Fraunhofer IEE and Professor for Electromobility and Electrical Infrastructure at Bonn-Rhein-Sieg University of Applied Sciences. He received his engineering degree in automation in 2008 by the THM Technische Hochschule Mittelhessen (FH Giessen-Friedberg). Afterwards he studied power engineering at University of Kassel and received his diploma certificate in 2010. In 2016 he received the Ph.D. (Dr.-Ing.) from the University of Hannover. The title of his dissertation is Optimized multifunctional bi-directional charger for electric vehicles. He has been a researcher at the Fraunhofer IEE in Kassel since 2010 and deals with power converters for electric vehicles, photovoltaics and wind energy. His current research interests include the bidirectional inductive power transfer, battery charger and inverter as well as new power electronic components such as SiC MOSFETs and chokes. Additionally, our key expert is Chairman of the IEEE Joint IAS/PELS/IES German Chapter and a member of the International Scientific Committee of the EPE Association. Our second course expert is deputy head of energy storage department at Fraunhofer IEE. Prior to this he was the Director of Grid Integration department at SMA Solar Technology AG, one of the world's largest manufacturers of PV power converters. Before joining SMA, our course expert was manager of the Front Office System Planning at Amprion GmbH (formerly RWE TSO), one of the four German transmission system operators. He holds a degree of electrical engineering of the University of Kassel, Germany. In 2003 he finished his Ph.D. (Dr.-Ing.) on the topic of wind power forecasting at the 'Institute of Solar Energy Supply Technology' (now Fraunhofer IEE) in Kassel. In 2004 he started his career at RWE TSO with main focus on wind power integration and congestion management. Our course expert is chairman of the IEC SC 8A 'Grid Integration of Large-capacity Renewable Energy (RE) Generation' and has published several papers about grid integration of renewable energy source and forecasting systems on books, magazines, international conferences and workshops. Our third course expert is Research Associate at Fraunhofer IEE. He is actively working on different projects related to the integration of electric vehicle charging into the electric distribution grid. The focus of this work concerns time series based simulations for grid planning and operation in order to investigate the effect of a future rollout of electric vehicles and charging infrastructure on economics e.g. costs for grid reinforcement. He completed his master degree (MSc.) in Business Administration and Engineering: Electrical Power Engineering at RWTH Aachen University, Germany. Our trainers are experts from Fraunhofer Institute for Energy Economics and Energy System Technology (Fraunhofer, IEE), Germany. The Fraunhofer IEE researches for the national and international transformation of energy supply systems POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information about post training coaching support and fees applicable for this. Accreditions And Affliations

Plasma pen fibroblast training for the face and body including soft surgery. Train one to one or very small groups. International accreditation. Lifelong support. Train with Carol May LMA Skin Clinic. On completion you will be able to offer your clients: Wrinkle rejuvenation & face lifting Hooded eyes & eye bags Glabella lines Nasal labia Marionette lines Neck lines Stretch marks & scar repair Mole removal Skin tags Cherry angioma Thread veins Xanthelasma Seborrheic keratosis plus many more soft surgery options You will benefit from online pre study plus in-clinic training and ongoing support Models can be provided if required You will receive a genuine medical grade plasma device (not electrical arcing) Total price is £2400 Your training fee can be paid in installments with Klarna We welcome national and International students

The NVQ Diploma in Construction Site Management – Retrofit qualification is suited to those who are working in a management role in the Retrofit construction sector and are looking to become eligible for the Black CSCS Card. Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.

The NVQ Diploma in Construction Site Management qualification is suited to those who are working in a management role in the construction industry and are looking to become eligible for the Black CSCS Card. Candidates follow one of five pathways depending on their job role: Building and Civil Engineering Highways and Maintenance Repair Residential Development Conservation Demolition Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.

The NVQ Level 4 Diploma in Construction Site Supervision – Retrofit is appropriate for individuals who work as a Construction Site Supervisor/ Foreman or Assistant Site Manager in the Retrofit construction sector and are looking to become eligible for the Gold ‘Site Supervisor’ CSCS Card. Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.

The NVQ Diploma in Construction Contracting Operations Management qualification is suited to those who are working in a management role in the construction industry and are looking to become eligible for the Black CSCS Card. Candidates follow one of five pathways depending on their job role: General Estimating Buying Planning Surveying Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.

The NVQ Diploma in Senior Construction Management Qualification is suited to those who are engaged in high level management activity of a construction business and who working in a senior management role and are seeking to obtain the Black CSCS Card. Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Complete your qualification quickly with the support of your assessor in as little as 10 to 12 weeks providing that you work with your assessor to provide the required evidence. We offer two other qualifications that lead to the Black CSCS card, follow the links below for more information (open in new window): Level 6 NVQ Diploma in Construction Contracting Operations Management – 8 Units – Complete in as little as 10 weeks. Level 6 NVQ Diploma in Construction Site Management – 19 units – Complete in as little 16 to 20 weeks. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.

The NVQ Level 4 Diploma in Construction Site Supervision is appropriate for individuals who work as a Construction Site Supervisor/ Foreman or Assistant Site Manager in the construction sector and are looking to become eligible for the Gold ‘Site Supervisor’ CSCS Card. Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.