120 Environmental courses in Manchester

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

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ITIL® 4 Leader: Digital and IT Strategy: In-House Training The ITIL® 4 Leader: Digital and IT Strategy (DITS) is one of the two modules in the ITIL® 4 Strategic Leader (SL) certification scheme. The other module in the SL designation is the ITIL® 4 Strategist: Direct, Plan & Improve. Accredited training for the ITIL® 4 Strategic Leader modules is mandatory to enable full understanding of the core material. The ITIL ® 4 Digital and IT Strategy certification focuses on enabling business success through the creation of digital and IT strategies. The IT and Digital Strategy certification adds a new perspective to the ITIL suite and elevates the discussion around ITIL concepts to a strategic level among business leaders and aspiring leaders. The ITIL® 4 Digital and IT Strategy course is based on the ITIL® 4 Digital and IT Strategy exam specification from AXELOS. With the help of ITIL® 4 concepts and terminology, exercises, and examples included in the course, you will acquire relevant knowledge to pass the certification exam. The core learning material in the course is supported by interactive case study, discussions and activities. What You Will Learn The ITIL ® 4 Digital and IT Strategy course covers the content in relation to the following learning outcomes of the exam specification for ITIL ® 4 Digital and IT Strategy: Demonstrate the use of the ITIL guiding principles in Digital and IT Strategy decisions and activities Understand how to leverage digital strategy to react to digital disruption Understand the relationship between the concepts of Digital and IT Strategy, the service value system and the service value chain, and explain how to utilize them to create value Understand how an organization uses Digital and IT Strategy to remain viable in environments disrupted by digital technology Understand strategic approaches made possible by digital and information technology to achieve customer/market relevance and operational excellence Understand the risks and opportunities of Digital and IT Strategy Understand the steps and techniques involved in defining and advocating for a Digital and IT Strategy Understand how to implement a Digital and IT Strategy Key Concepts of Digital and IT Strategy Digital, Information, and Communication Technology Digital Transformation Services, Products, and Competitive Advantage Tiers of Strategy Business Models Operating Models Strategy and the Service Value System Opportunity and Demand Value Governance ITIL® Guiding Principles Continual Improvement ITIL® Practices What is Vision? Disruptions Vision Digital Disruptions Balanced Strategic Focus Positioning Tools for Digital Organizations Assignment 1: Digital Disruption and Digital Positioning Where Are We Now? Environmental Analysis Opportunity Analysis Digital Readiness Assessment How Do We Get There (Strategic Planning) Strategy Planning Financial Aspects of Digital and IT Strategy Business Models for Strategy Planning Portfolio Optimization How Do We Get There (Strategic Approaches) Strategic Approaches for Digital Organizations Strategic Approaches for Operational Excellence Strategic Approaches to Evolution Strategic Approaches to Social Responsibility and Sustainability Assignment 2: Strategic Approaches for Digital Organizations Take Action (Managing Strategic Initiatives) How Strategies are Implemented Coordinating Strategy and Strategic Initiatives Leading Digital Transformation Digital Leadership Assignment 3: Strategy Planning and Communication Did We Get There? (Measuring Strategy) Key Facts About Measurement Measuring a Strategy Instrumenting Strategy How Do We Keep the Momentum Going Long-Term Momentum: Ensuring Organizational Viability Short-Term Momentum: Parallel Operation Assignment: Digital Strategy in VUCA Environment Managing Innovation and Emerging Technologies Managing Innovation Formal Approach to Innovation Management Culture that Supports Innovation Approaches to Innovation Evaluating and Adopting Emerging Technology Managing Strategic Risk Risk Management Risk Identification Risk Posture Risk Treatment

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