78 Courses in Manchester

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

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

Certified Business Analysis Professional™ (CBAP®) Boot Camp: In-House Training The course provides targeted exam preparation support for IIBA® Level 3 - CBAP® exam candidates, including both a BABOK® Guide Version 3.0 content review and exam preparation tutorial. The class is interactive, combining discussion, application of concepts, study tips, and a practice exam. Knowledge Check quizzes and self-assessments allow candidates to identify areas of weakness and create a custom study plan tailored to their individual needs as well as study aids to support their exam preparation after the course. The course materials include a copy of A Guide to the Business Analysis Body of Knowledge® (BABOK® Guide) Version 3.0. What you will Learn Upon completion, participants will be able to: Demonstrate familiarity with the structure and content of the IIBA® BABOK® Guide Improve their probability of passing the Level 3 - CBAP® Exam Identify their knowledge gaps through the use of module Knowledge Check quizzes Gauge their readiness for taking the exam by IIBA® BABOK® Guide Knowledge Are Foundation Concepts for IIBA® CBAP® Prep IIBA® - the Organization Business Analysis - the Profession Knowledge Check Terminology and Key Concepts IIBA®'s BABOK® Guide - the Standard Underlying Competencies BA Techniques Business Analysis Planning and Monitoring Knowledge Check Overview BAP&M Tasks BAP&M Techniques Elicitation and Collaboration Knowledge Check Overview E&C Tasks E&C Techniques Requirements Life Cycle Management Knowledge Check Overview RLCM Tasks RLCM Techniques Strategy Analysis Knowledge Check Overview SA Tasks SA Techniques Requirements Analysis and Design Definition Knowledge Check Overview RA&DD Tasks RA&DD Techniques Solution Evaluation Knowledge Check Overview SE Tasks SE Techniques Exam Preparation Practice Exam and debrief Exam Preparation Study Tips Manage Study Plan Exam Process Exam day

PMI-PBA® Exam Prep: In-House Training The course provides targeted exam preparation support for PMI®'s Professional in Business Analysis exam candidates, including a content review of The PMI Guide to Business Analysis, a review of the PMI-PBA® reference books, and an exam preparation tutorial. You will be given a Study Guide that you can re-use to assess your knowledge gaps as part of your Personal Action Plan. Your score on this for each Knowledge Area can be compared to your results on the quiz at the end of each course module to guide your study efforts. What you will Learn Upon completion, participants will be able to: Demonstrate familiarity with the structure, content and framework of The PMI Guide to Business Analysis Explain the six Knowledge Areas of The PMI Guide to Business Analysis, as well as, their inter-relationships with each other and the six Process Groups Differentiate among the five business analysis domains in the project life cycle Create a personal action plan to study and prepare for the PMI-PBA® Exam Getting Started PMI-PBA Examination Certification Process The Credential Examination Foundation Concepts for PMI-PBA® Prep Business analysis terminology and definitions Business analysis project, program, and portfolio management Product and project life cycles Skills and qualities of a business analyst Introduction to Business Analysis in Projects Business analysis overview How organizations implement business analysis Business analyst and project manager relationships Requirements definitions and types Practice quiz On-Demand Segment A: Define the Business Problem (Pre-work for Needs Assessment) Needs Assessment Review Needs Assessment knowledge area Identify problem or opportunity Assess current and future state Determine options and provide recommendations Facilitate product roadmap development Assemble business case Practice quiz Stakeholder Engagement Review Stakeholder Engagement knowledge area Identify Stakeholders and conduct analysis Determine Stakeholder engagement and communication approach Conduct business analysis planning Practice quiz On-Demand Segment B: The Elicitation Plan (Pre-work for Elicitation) Elicitation Review Elicitation knowledge area Determine Elicitation approach Preparing for Elicitation Conducting Elicitation Confirming Elicitation results Practice quiz On-Demand Segment C: Overview of Requirements Analysis (Pre-work for Analysis) Analysis Review Analysis knowledge area Determine Analysis approach Create and analyze models Define requirements and acceptance criteria Verify, validate, and prioritize requirements Identify and analyze product risks Assess product design options Practice quiz Traceability and Monitoring Review Traceability and Monitoring knowledge area Determine Traceability and Monitoring approach Establish relationships and dependencies Select and approve requirements Make changes to requirements and other product information Practice quiz Solution Evaluation Review Solution Evaluation knowledge area Evaluate solution performance Determine solution evaluation approach Evaluate acceptance results and address defects Obtain solution acceptance for release Practice quiz Exam Application and Preparation Process Applying for the Exam Studying for the Exam Sitting for the Exam Reviewing your Knowledge Gap Practice Exam Study Guide - a reliable learning aid Summary and Next Steps Crystallizing the Business Analysis Domains Developing a Personal Action Plan for Exam Study

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.

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