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
The course will cover special procedures and the benefits of using IP and OP in your compliance.
This module aims to develop knowledge and understanding of the impact of Import/Export freight movement on the environment and the opportunities available to organisations to use sustainable options. we will cover CBAM , Deforestation, GSPR and many challenges facing Exporters and Importers.
International markets offer huge Export opportunities for UK businesses. Finding and developing new markets for products is a hugely valuable avenue for expansion and in some sectors in particular, global demand for British brands and products makes international trade an excellent means of growth.
You have 2 options here: Emergency Paediatric First Aid (EPFA) is a 1 day course designed to prepere you for worst case scenarios with children and babies. 1 day face to face 9am untill 4pm Paediatric First Aid Blended (PFAB) is a 2 day course covering everything from EPFA above and adding on a range of additional conditions and injuries you may need to deal with when caring for children. 2 days, 1 online in your own time and 1 classroom day 9am to 5.15 pm First Aid Training is a relaxed and enjoyable day, assessment will not be stressful, we aim to help you learn and support you to get what you need from the day. There are some practical and some multiple choice assessments for First Aid qualifications. First Aid can be quite physical, you will need to be able to kneel on the floor to perform CPR and recovery position.
This course covers import documentation and procedures, commercial considerations, the importance of your purchase order, calculating VAT and duty, and how to reduce import customs clearance delays.
Trauma Informed Practice in Education is a research evidence based whole school systems approach that starts with you. Improved attendance, improved learning outcomes, reduced suspensions and exclusions and better staff recruitment, retention and wellbeing all begin from a place of understanding child development, the impact of adversity on child development and the role of us as educators in supporting opportunities for growth and resilience. Systems change takes teamwork, however the most important member of that team is you. On this Trauma Informed Practice Day you will learn the why and how to keep you well and resourced in order to support the emotional and academic progress of the children in your school. You may already have some knowledge or you may be coming as a complete novice. Either and anything in between is fine. Numbers are limited to keep the group small for the benefit of more enriched learning. On this practice day you will; • Take a deep learning dive into the nervous system and how this applies to you, your setting and the progress of your learners. • Learn practical skills and strategies to support yourself and others. • Have opportunities to discuss children you are working with through small group supervision sessions • Benefit from a day of immersion into the topic with two highly qualified and experienced practitioners.
Introduction to International Trade This module provides a foundational understanding of the development and significance of international trade, focusing on the UK's trade strategy and its global role. Participants will explore key topics such as trade definitions, the World Trade Organization (WTO), the evolution of customs, and major post-WW2 trade developments. Additionally, the module covers the UK's entry into and exit from the EU, and the current UK Digital Strategy for International Trade. **Agenda Highlights**: - Definitions and importance of international trade - Overview of the WTO - Customs fundamentals - Post-WW2 global trade growth - Impact of EU membership and Brexit - UK Digital Strategy for international trade growth
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.
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.