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 Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) is usually a one-year pre-university qualification that provides students with an entry route to an overseas university. The L3IFDHES prepares students with the essential English language skills, key transferable study skills, cultural knowledge, and chosen specialisms that universities feel bridges the gap between high school and undergraduate study. In January 2023 we offer pathways in business and higher finance. With agreements in place with over 70 universities across the globe, students’ can progress with confidence to a higher education course for further study. Entry Requirements For entry onto the NCC Education Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) qualification students must have successfully completed secondary school education. Students must also meet the English language entry requirements of: • IELTS minimum score of 4.5 or above OR • GCE ‘O’ Level English D7 or above Alternatively, a student can take the free NCC Education Higher English Placement Test which is administered by our Accredited Partner Centre’s.
The Gold Card Training Programme is the most comprehensive electrician course available. We offer weekday, weekend and evening delivery options. JIB ECS (Gold) Card is quickly becoming a necessity when seeking work on commercial sites, or sub-contracting to larger contractors.
The shortage of electricians has lead to an increased demand nationwide and in turn a sharp rise in salary. Our training solutions can help you gain nationally recognised qualifications such as City & Guilds and NVQ. Not only you will train in state-of-the-art training centres, but you can also have the opportunity to attain the Work Based Performance Units and complete a portfolio of diverse evidence of onsite work.
Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud, corruption and associated financial crime and money laundering.
Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud and corruption.
4and20Million run Sustainable Excellence, a course designed to help people unlock their productivity, without resorting to longer hours and unnecessary stress. For full details, further information and learning more about how to boost your career prospects, please contact: dan@4and20million.com alex@4and20million.com
In-house training courses on electric and hydrogen vehicle technologies, charging infrastructure and how they work.