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
Overview In this competitive era no matter how much hard work and solid efforts are contributed still, too many projects end up creating unneeded and unsellable products. There is a significant risk that the outcome of the project may not be relevant to the client/user requirements or become outdated when needs change. Here is where Design Thinking and Agile Management play their role. The combination of Agile and Design Thinking should be used in order to achieve impactful outcomes. Agile and design thinking together works well and gives an effective approach to product development, one that results in efficient resolutions to significant problems. In this course, you'll learn how to define and determine what's important to a user primary in the process, to frontload value, by directing your team on testable narratives about the user and generating an effectively shared perspective. For more dates and Venue, Please email sales@gbacorporate.co.uk
This half-day workshop delivered face-to-face or online is designed for anyone in your organisation that wants to become a Neurodiversity Champion - someone who wants to educate and change the way that Neurodiversity is viewed in the workplace.
This half-day Suicide First Aid Lite training course gives learners the knowledge and tools to understand that suicide is one of the most preventable deaths and some basic skills can help someone with thoughts of suicide stay safe from their thoughts and stay alive.
Microsoft Active Directory course description A thorough understanding of this system is essential for anyone managing enterprise MS networks. Essential theory is complimented with a high level of hands on practice allowing delegates to observe the idiosyncrasies of Active Directory and Group Policy at first hand. Delegates learn the fundamental theory of AD and progress onto building a multi-domain network in the classroom. The course includes troubleshooting methods, and essential maintenance procedures. This course is designed to teach you the skills needed for day to day management of these technologies. What will you learn Install AD on multiple PCs. Use the tools to create and manage objects. Create appropriate group policies to restrict selected user's desktops and network access. Install DNS to support Active Directory without loosing Internet Connectivity. Maintain and troubleshoot AD problems Backup Active Directory. Microsoft Active Directory course details Who will benefit: Technical staff working with AD based networks. Prerequisites: Supporting Windows server. Duration 3 days Microsoft Active Directory course contents Introduction to Active Directory Network authentication methods, Active Directory defined, AD naming conventions, network management with AD, AD structures: Domains, Organisational Units, Forests & Trees, Sites, The Global Catalogue. Windows 2003 new features, installing AD. Hands on Installing an AD network. Windows overview Management methods Server management tools, installing the additional tools, Terminal Server: Administration mode, Administrator accounts in AD, Local Security Policy. Hands on Install the management tools, Management using Terminal Services. Creating & Managing Objects (a quick look) AD management tools, AD users and computers, Creating & managing OUs, User Accounts and groups, controlling access to AD objects, moving objects, Publishing resources, locating objects in AD, delegating authority. Hands on Creating a control OU structure and delegating authority. Introduction to Group Policies What are Group Policies? Where Group Policy data is stored, security, Group Policy flow. Hands on Implementing Group Policies Working with Group Policies Local security templates, administrative templates, scripts, folder redirection, software deployment. Hands on Scripts, redirecting the start menu, creating a secure, robust desktop environment. Implementing DNS DNS basics, troubleshooting, implementing DNS zones. Hands on Building a unified DNS solution. Maintaining and managing the AD database AD support tools, database internal structure, replication, replication tools, Single Operations Masters, tools for maintenance, maintenance techniques, Backing up AD, Directory Services restore mode, NTDSUtil, Authoritative & non-authoritative restoration, rebuilding. Hands on NTDSUtil.
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.