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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
This market-leading health and safety course enables companies to demonstrate compliance and embed health and safety into the company culture. Whilst anyone can attend, it is particularly beneficial for line managers, team leaders and supervisors. It is tried, tested and trusted.
This training focuses on performance management as a continuous process that drives development. It helps bring consistency in applying performance management within the business. The course will help managers recognise their role and contribution to effectively manage performance and conduct at work.
We need to talk openly about how we are performing and we sometimes need to have an 'honest' conversation with our manager. We all know this, but it can be difficult. This short, focused workshop will give you the confidence and skills to have a conversation with your manager (or anyone else for that matter) about your performance and how you can add value. It will focus on how to get yourself heard and build better working relationships with those key to your success. The programme will help you: Overcome the barriers to effective performance conversations Receive feedback without taking it personally Improve working relationships with your manager Agree realistic expectations and targets (and get 'buy-in' for them) Improve your communication style Plan and prepare for honest conversations in the workplace 1 What is an honest conversation? Why don't we have them more often? What stops us? The cost of not having them 2 Asking for feedback 3 Preparing for challenge 4 The expectations conversation 5 Your communication styles 6 Planning and preparing for an honest conversation
The course will increase participants knowledge relating to how drugs work, potential risks and hazards associated with medicines, and provide an overview of the legal and professional aspects of medicines management.
Five half-day Leadership modules with mini work placed projects to bring the learning into action in the workplace.
Five half-day Leadership modules with mini work placed projects to bring the learning into action in the workplace.
Four half-day Leadership modules with mini work placed projects to bring the learning into action in the workplace.
Helping people become more efficient in how they manage and prioritise their working day, and for leaders and managers, how they can work efficiently by collaborating effectively with their people.