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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Introduction to Virtualization course description A comprehensive tour of virtualization. The course concentrates on the actual technologies involved as opposed to any one vendor solution. What will you learn Explain the concepts of virtualization. Partition servers. Create Virtual Machines. Introduction to Virtualization course details Who will benefit: Anyone looking for an introduction to Virtualization. Prerequisites: None. Duration 2 days Introduction to Virtualization course contents Virtualization Concepts What is Virtualisation? What are virtual machines (VMs)? Virtualisation Landscape. Network Virtualisation. Suitability for Organisations. Advantages of deploying Virtualisation. Downsides of deploying Virtualisation. Overview of Virtualisation products. Hypervisors What is a hypervisor? Difference between type 1 and 2 hypervisors. Available hypervisors. Hypervisors and device drivers. Hands on: Installing Oracle VirtualBox on Windows. Creating/Importing/Configuring VMs. Virtualization Hosts Hardware and resource requirements. Installation of the hypervisor. Hands on: Installing Hyper-V role into Windows Server. Creating/Importing/Configuring VMs. Virtual Machines Creating virtual machines. Resource requirements. Settings. Installation of the guest OS. Additional tools/ extensions for hypervisor integration. VM files and their uses. Virtual hard disk and their formats. Hardware pass through. Hands on: Connecting to VMWare ESXi via WebGUI and using ESXi to create/import/configure VMs. VM Snapshots/Checkpoints What is a snapshot? How to use them and how they impact performance? Creating/deleting/merging of snapshots. Hands on: Using ESXi to create/manage snapshots. Command Line use on the Hypervisor Interacting with the hypervisor through the command line. Simple commands to configure the hypervisor and VMs. Simple scripts. Hands on: Connecting to VMWare ESXi via PowerCLI to manipulate VMs and snaphshots. Virtualization Storage Different types of storage: local vs remote. Local and remote storage technologies. Configuring storage. Hands on: Using ESXi to deploy VMs on remote NFS storage. Virtual Networking How is networking done in virtualization environments. What is a virtual switch and vNIC and what are their performance characteristics? NIC teaming and trunking in the virtual world. Port groups and isolation. Physical NICs and their use in virtual switches. Hands on: Using ESXi to create and configure vswitches and networking. Templates and clones What is a template? What is a clone? When to use templates and clones to optimize VM deployment. Migrating/Importing VMs What is migration? Migrating compute and storage. Importing VMs from files or physical machines. Hands on: Using VMWare vCenter Server to clone/ template/migrate VMs, tag resources, create local user accounts and assign permissions. VMs and Backups Taking backups of your VMs. Restoring your VMs from backups. Virtualization and Licensing Different licensing models and costs. Containerization Concepts What is a container and how is it different from a virtual machine. When to use containers. Docker and Kubernetes
Basic Life Support (BLS) Course
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
Helping people become more efficient in how they manage and prioritise their working day, and for leaders and managers, how they can work efficiently by collaborating effectively with their people.
Management of Value (MoV®) Practitioner: In-House Training This interactive MoV® Practitioner course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn The MoV Practitioner Course prepares you for the MoV Practitioner exam. Individuals certified at the MoV Practitioner level will be able to: Apply Management of Value (MoV) principles, processes and techniques, and advocate the benefits of this application appropriately to the senior Management. Develop a plan of MoV activities for the whole lifecycle of small and large projects and programs. Plan an MoV study, tailoring it to particular projects or programs and developing practical study or workshop handbooks as required. Understand and articulate value in relation to organizational objectives. Prioritize value drivers using function analysis and use these to demonstrate how value might be improved. Quantify monetary and non-monetary value using the Value Index, Value Metrics and the Value for Money ratio. Describe and comment on the application of various techniques relevant to MoV. Monitor improvements in value realized throughout a project lifecycle and capture learning which can be transferred to future projects. Offer suggestions and guidance about embedding MoV into an organization, including policy issues, undertake a health check, assess maturity and competence, and provide guidance on typical roles and responsibilities. Understand and articulate the use of MoV within other Best Management Practice methods and its contributions to them Benefits of Taking This Course Upon successful completion of this course, you will be able to: Organise and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach, and environment Analyse a company, programme or project to establish its organisational value includes identification and weighting of Value Drivers Pass the AXELOS Practitioner Examination Function Analysis Customer FAST Diagram Value Tree Development Weighting Attributes Paired Comparisons Developing a Value Profile Developing a Value Index Value for Money Ratio Stimulating Innovation Value Engineering Option Evaluation and Selection Evaluation Matrix Value and Value for Money Timing and Planning Teams and Stakeholders MoV in the Organization Integrating with Best Management Practice Relationship between Process and Approach
Our suite of modules are based around helping the customer to buy and enabling salespeople to maximise their conversations with their customers.