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 This training course will give participants a developed knowledge of credit analysis. Through a mix of lectures and interactive case studies, participants will be able to perform detailed credit analysis, including analysing market and environment, computing key financial ratios, interpreting cash flows and analysing financing needs. Key Topics Financial needs and the business operating cycle Review of financial statements Financial ratio analysis Corporate cash flow analysis Cash flow projections for debt service Key lending policy guidelines
If you want to start installing independently or with an electrical contractor look no further as this course will give you the skills and knowledge required. This package which will allow you to become a fully qualified domestic installer and enable you to join a Competent Person Self-Certification Scheme and certify your own domestic work.
In the modern work environment, managers and leaders must treat all colleagues with respect, including those who are challenging. Understanding the causes of difficult behaviour and being self-aware are crucial for creating a fair and inclusive workplace. This training session equips participants with the knowledge and communication tools to manage and overcome difficult behaviours effectively. This course is available to book for delivery in-house for your organisation and people exclusively, for either a half or full days training workshop. Prices are dependent on size of group ranging from a minimum of 4 to a maximum of 12 delegates. If you have a smaller number of delegates the Puritas 1:1 Leadership Coaching Programme is recommended.
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Are you passionate about the business side of film? Do you have an entrepreneurial mindset and ambitions to pave a career in a fast-growing creative industry? The BA (Hons) Film Business & Production degree reflects current demands for professionally ready graduates equipped with the vital creative, business and entrepreneurial skills to navigate the modern film, screen and media environment.
APM Project Management Qualification (PMQ): In-House Training The APM Project Management Qualification (PMQ) (IPMA Level D) is a knowledge-based qualification that allows candidates to demonstrate knowledge of all elements of project management. Candidates will be able to demonstrate an understanding of how these elements interact and how their project fits into their strategic and commercial environment. The course will cover the 67 assessment criteria defined by APM and prepare you to sit the examination on the fifth and final day. In addition to the instructor-led sessions, you should also expect to complete some self-directed study in the evenings. The APM Project Management Qualification (PMQ) examination is a three-hour paper where candidates must answer 10 out of 16 questions that can cover all 67 assessment criteria topics. What you will Learn You'll learn how to: Provide organizations with a proven project management methodology that will allow individuals to plan, organize, and control the successful implementation of projects Achieve the APM Project Management Qualification (PMQ), the UK's leading project management qualification Provide practical skills and techniques to help further your career in project management Getting Started Introductions Course structure Course goals and objectives Overview of the APM Project Management Qualification (PMQ) examination Structure of Organizations and Projects Organization structures Project sponsorship Organization roles Project Office Governance Legislation Project Lifecycle Project Lifecycles Handover and closure Project reviews Situational Context of Projects Project Management Programme Management Portfolio Management The Project Environment Communication Communication Conflict Management Negotiation Leadership and Teamwork Leadership Teamwork Planning for Success Business Case Investment Appraisal Success and Benefits Management Information Management and Reporting Project Management Plan Estimating Earned Value Management Stakeholder Management Scope Management Scope Management Requirements Management Change Control Configuration Management Schedule and Resource Management Schedule Management Resource Management Budgeting and Cost Management Procurement Procurement Contracts Provider Selection and Management Risk Management and Issue Management Risk Management Issue Management Quality Management and Examination Preparation Quality Management Preparation and Examination Preparation and examination briefing APM Project Management Qualification (PMQ) examination
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