11119 Courses

PRINCE2® Foundation Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends

ITIL® 4 Foundation ITIL® 4 is built on the established core of best practice in the ITIL® guidance. ITIL® 4 provides a practical and flexible approach to move to the new world of digital transformation and embrace an end-to-end operating model for the delivery and operation of products and services. ITIL® 4 also provides a holistic end-to-end picture that integrates frameworks such as Lean IT, Agile, and DevOps. The ITIL® 4 Foundation is based on the exam specifications specified by AXELOS for the ITIL® 4 Foundation certification. The fundamental objective of this course is to help the participants understand the key concepts of service management and the ITIL® 4 service management framework and prepare for the ITIL® 4 Foundation exam. In addition, this course offers a rich learning experience that helps the participants relate ITIL® to their own work environment. The course includes a case study (based on a fictitious organization, 'Axle Car Hire') that will help the participants understand and experience the ITIL® guiding principles, service value, practices through real-world challenges and opportunities. The rich learning experience is supported by additional learning tools such as pre-course reading materials, post-course reading material, and a set of quick reference cards. What You Will Learn At the end of this program, you will be able to: Understand the key concepts of ITIL® service management Understand how ITIL® guiding principles can help an organization to adopt and adapt ITIL® service management Understand the four dimensions of ITIL® service management Understand the purpose and components of the ITIL® service value system, and activities of the service value chain, and how they interconnect Understand the key concepts of continual improvement Learn the various ITIL® practices and how they contribute to value chain activities Course Introduction Let's Get to Know Each Other Course Overview Course Learning Objectives Course Structure Course Agenda Introduction to IT Service Management in the Modern World Introduction to ITIL® 4 Structure and Benefits of ITIL® 4 Case Study: Axle Car Hire Case Study: Meet the Key People at Axle Case Study: The CIOs Vision for Axle Exam Details ITIL® 4 Certification Scheme Service Management - Key Concepts Intent and Context Key Terms Covered in the Module Module Learning Objectives Value and Value Co-Creation Value: Service, Products, and Resources Service Relationships Value: Outcomes, Costs, and Risks Exercise: Multiple-Choice Questions The Guiding Principles Intent and Context Identifying Guiding Principles Key Terms Covered in the Module Module Learning Objectives The Seven Guiding Principles Applying the Guiding Principles Exercise: Multiple-Choice Questions The Four Dimensions of Service Management Intent and Context The Four Dimensions Key Terms Covered in the Module The Four Dimensions and Service Value System Module Learning Objectives Organizations and People Information and Technology Partners and Suppliers Value Streams and Processes External Factors and Pestle Model Exercise: Multiple-Choice Questions Service Value System Intent and Context Service Value System and Service Value Chain Module Learning Objectives Overview of Service Value System Overview of the Service Value Chain Exercise: Multiple-Choice Questions Continual Improvement Intent and Context Key Terms Covered in the Module Introduction to Continual Improvement Module Learning Objectives The Continual Improvement Model Relationship between Continual Improvement and Guiding Principles Exercise: Multiple-Choice Questions The ITIL® Practices Intent and Context ITIL® Management Practices Key Terms Covered in the Module Module Learning Objectives The Continual Improvement Practice The Change Control Practice The Incident Management Practice The Problem Management Practice The Service Request Management Practice The Service Desk Practice The Service Level Management Practice Purpose of ITIL® Practices Exercise: Crossword Puzzle

PMI-RMP® Exam Prep This course is aimed at preparing the participant to pass the PMI-RMP® (Risk Management Professional) exam. The course will also provide practical tips and tools that can be used in any organization's project management risk practices. In this expanded session, you will also have time to practice your exam taking skills with coaching from a credentialed instructor. The course includes the tool RMP-IQ, with sample exam questions to practice for the exam and allow participants to see their knowledge level in the various domains. What You Will Learn At the end of this course, participants will be able to: Explain the value and benefits of the PMI-RMP® credential Perform a self-assessment of your knowledge and skills Prepare a study plan that will allow you to pass the exam Foundation Concepts The Risk Management Professional (PMI-RMP®) Exam PMI's Standard for Risk Management Portfolios, Programs and Projects Key risk definitions Risk management life cycle Levels of Risk Management Enterprise Risk Management Portfolio Risk Management Program Risk Management Project Risk Management Risk Strategy and Planning: Part 1 Task 1: Perform a preliminary document analysis Task 2: Assess project environment for threats and opportunities Task 3: Confirm risk thresholds based on risk appetites Risk Strategy and Planning: Part 2 Task 4: Establish risk management strategy Task 5: Document the risk management plan Task 6: Plan and lead risk management activities with stakeholders Agile, programs, and portfolio aspects of risk strategy and planning Risk Identification: Part 1 Objectivity and bias Task 1: Conduct risk identification exercises Risk Identification: Part 2 Task 2: Examine assumption and constraint analysis Task 3: Document risk triggers and thresholds based on context / environment Task 4: Develop risk register Agile, programs, and portfolio aspects of risk identification Risk Analysis: Part 1 Task 1: Perform qualitative analysis Risk analysis in an agile environment Risk Analysis: Part 2 Task 2: Perform quantitative analysis Task 3: Identify threats and opportunities Program and portfolio aspects of risk analysis Risk Response Task 1: Plan risk responses Agile, programs, and portfolio aspects of risk response planning Task 2: Implement risk responses Monitor and Close Risks: Part 1 Task 1: Gather and analyze performance data Monitor and Close Risks: Part 2 Task 2: Monitor residual and secondary risks Task 4: Monitor project risk levels Task 3: Provide information required to update relevant project documents Agile, programs, and portfolio aspects of monitoring and closing risks

PRINCE2 Agile® Foundation PRINCE2 Agile® provides structure, governance, and control when working with agile concepts, methods, and techniques. It is a solution combining the flexibility and responsiveness of Agile with the clearly defined framework of PRINCE2. PRINCE2 Agile® framework covers a wide range of agile concepts, including SCRUM, Kanban, and Lean Startup. The PRINCE2 Agile® Foundation certificate is designed to help professionals deliver agile projects by tailoring PRINCE2® management controls with a broad toolset of agile delivery techniques and frameworks. PRINCE2 Agile® is an extension module tailored for forward-thinking organizations and individuals already benefiting from PRINCE2®. It provides further guidance on how to apply agile methods to the world's most recognized project management method. The purpose of the Practitioner qualification is to demonstrate that you can apply and tailor PRINCE2 Agile® in a scenario situation. What you will Learn Understand the key aspects of PRINCE2® Understand basic concepts behind common agile ways of working Demonstrate the purpose of combining PRINCE2® with agile Be able to fix and flex the aspects of a project in an agile context Apply the PRINCE2® principles and tailor the themes, processes, and management products to a project in an agile context Incorporate the areas that can support a PRINCE2 Agile® implementation To prepare Participants for the PRINCE2 Agile® Foundation exam Benefits Agile methods allow organizations to realize the benefits of products and potentially an earlier return on investment while products are being developed and improved. Improved communication through the use of common terminology across PRINCE2® and agile disciplines. Develop a clear definition of how agile can govern a project's delivery, while PRINCE2® governs projects as a whole. Seamless integration: PRINCE2 Agile® will complementPMBOK® GuideandAPM Body of Knowledge®just as PRINCE2® does currently. It will also be of interest for Program Managers with MSP® who need to understand how projects relate to the delivery mechanism. The most up-to-date and relevant view of Agile project management methodologies, PRINCE2 Agile® references the 'flow-based' working featured in Kanban in addition to other agile concepts not covered in other qualifications. Introduction - Getting Started Part 1 An overview of PRINCE2 Agile Overview Blending PRINCE2 and Agile What to fix and what to flex Part 2 Agile behaviors ad the PRINCE2 Principles Agile and the PRINCE2 Themes Part 3 Focus areas Agile and the PRINCE2 Processes Examination preparation Examination. Summary - What did we learn, and how can we implement this in our work environment?

PRINCE2 Agile® Practitioner PRINCE2 Agile® Practitioner is a solution combining the flexibility and responsiveness of Agile with the clearly defined framework of PRINCE2®. PRINCE2 Agile® framework covers a wide range of agile concepts, including SCRUM, Kanban, and Lean Startup. The PRINCE2 Agile® Practitioner certification teaches you to blend structure, governance, and control with agile methods, techniques, and approaches. The strength of PRINCE2® lies in the areas of project direction and project management, whereas Agile has a very strong focus on product delivery. When PRINCE2® and agile are combined, project direction, project management, and project delivery are optimized to create a complete project management solution. PRINCE2 Agile® is an extension module tailored for forward-thinking organizations and individuals already benefiting from PRINCE2®. It provides further guidance on how to apply agile methods to the world's most recognized project management method. The purpose of the Practitioner qualification is to demonstrate that you can apply and tailor PRINCE2 Agile® in a scenario situation. What you will Learn Understand the basic concepts of common agile ways of working Understand the purpose and context for combining PRINCE2® and the agile way of working Able to apply and evaluate the focus areas to a project in an agile context Able to fix and flex the aspects of a project in an agile context Apply the PRINCE2® principles and tailor the themes, processes, and management products to a project in an agile context To learn through the use of theory and practical exercises Prepare for the PRINCE2 Agile® Practitioner exam Benefits Agile methods allow organizations to realize the benefits of products and potentially an earlier return on investment while products are being developed and improved Improved communication through the use of common terminology across PRINCE2® and agile disciplines Develop a clear definition of how agile can govern a project's delivery, while PRINCE2® governs projects as a whole Seamless integration: PRINCE2 Agile® will complementPMBOK® GuideandAPM Body of Knowledge® just as PRINCE2® does currently. It will also be of interest for Program Managers with MSP® who need to understand how projects relate to the delivery mechanism. The most up-to-date and relevant view of Agile project management methodologies, PRINCE2 Agile® references the 'flow-based' working featured in Kanban in addition to other agile concepts not covered in other qualifications Agile Overview & Blending PRINCE2 and Agile Agile overview Blending PRINCE2 and Agile Fix and Flex, Agile and PRINCE2 Processes & Starting a Project Fix and Flex Agile and the PRINCE2 Processes; Starting up a project and Initiating a project Business case theme Change and Organization Themes& Principles Change theme Organization theme Agile and PRINCE2 Principles and the Agilometer Managing Product Delivery and Scrum & Plans and Progress Themes Managing product delivery and Scrum Plans Theme and Progress Theme Quality, Controlling & Managing a Stage and Directing Projects and Contracts Quality Theme Controlling a stage and Frequent Releases Managing a stage boundary Directing a project and contracts Closing a project Tailoring PRINCE2 Productsand Other Practices Tailoring PRINCE2 products and other practices

Better Business Cases™ Foundation Better Business Cases™ is based on the Five Case Model - which is the UK government's best practice approach to structuring spending proposals and making effective business decisions. Using this best practice approach will allow organizations to reduce unnecessary spending and improve the decision-making process which gives you a greater chance of securing necessary funding and support for initiatives. The goal of the foundation course is to enable participants to work effectively with a team to develop a strong business case in their work environment. What You Will Learn At the end of this program, you will be able to: Describe the philosophy and the underlying rationale of the Five Case Model Identify different types of business case, their purpose, who is responsible for them Recognize when the different types are required in the development of a spending proposal Develop the business case in relation to other recognized and recommended best practices for programme and project management Overview of the Five Case Model Five key components of a business case and the order in which they are presented Three key stages in the development of a spending proposal Definition of a programme / project and the key differences between programmes and projects Purpose of a Business Justification Case (BJC) and in what circumstances it should be considered Purpose of a Strategic Outline Case (SOC) Purpose of an Outline Business Case (OBC) Purpose of a Full Business Case (FBC) Relationship between policies, strategies, programmes, and projects and their deliverables Developing the Strategic Case Purpose and core content of a Strategic Case Purpose of SMART robust spending objectives and the key objectives for spend: economy, efficiency, effectiveness, re-procurement, and statutory or regulatory compliance Four main categories of benefits criteria and the parties involved in their development Three key categories of risk Purpose of identifying constraints and dependencies Difference between direct and indirect benefits Developing the Economic Case Purpose and core content of an Economic Case Purpose of critical success factors and the key critical success factors based upon the Five Case Model Purpose of the long list options and how to generate options and undertake SWOT analysis Minimum of four short-list options, how they are derived, and what they should include (Reference Project / Public Sector Comparator [PSC]) Difference between the preferred way forward and the preferred option Purpose, objectives, key participants, and outputs of Workshop Stage 2 - identifying and assessing the options Rules that should be followed for the treatment of costs and benefits Key differences between economic appraisals and financial appraisals Factors considered when selecting the preferred option Developing the Commercial Case Purpose and core content of a Commercial Case Guiding principles when apportioning risk between the contractual parties Purpose of payment mechanisms Purpose of Step 9 in the development framework: Contracting for the deal Developing the Financial Case Purpose and core content of a Financial Case The financial statements required for all projects The possible impacts to consider Developing the Management Case Purpose and core content of a Management Case Purpose of a programme / project management strategy, framework, and plan Purpose of a change management strategy, framework, and plan Purpose of a benefits realization strategy, framework, and register / plan Purpose of a risk management strategy, framework and register / plan Purpose of a post programme / project evaluation strategy, framework, and plan

RESILIA™ Foundation AXELOS RESILIA™: Cyber Resilience Best Practice is designed to help commercial and government organizations around the world prevent, detect, and correct any impact cyber attacks will have on the information required to do business. Adding RESILIA to the existing AXELOS global best practice portfolio, including ITIL® and PRINCE2®, brings a common cyber resilience best practice for security, IT service management, and business. Active cyber resilience is achieved through people, process, and technology. The RESILIA™ Foundation course starts with the purpose, key terms, the distinction between resilience and security, and the benefits of implementing cyber resilience. It introduces risk management and the key activities needed to address risks and opportunities. Further, it explains the relevance of common management standards and best practice frameworks to achieve cyber resilience. Subsequently, it identifies the cyber resilience processes, the associated control objectives, interactions, and activities that should be aligned with corresponding ITSM activities. In the final part of the course, it describes the segregation of duties and dual controls related to cyber resilience roles and responsibilities. What you will Learn At the end of this course, you will be able to: Demonstrate your knowledge of the purpose, benefits, and key terms of cyber resilience Demonstrate your knowledge of the risk management and the key activities needed to address risks and opportunities Demonstrate your knowledge of the purpose of a management system and how best practices and standards can contribute Demonstrate your knowledge of the cyber resilience strategy, the associated control objectives, and their interactions with ITSM activities Demonstrate your knowledge of cyber resilience design, the associated control objectives, and their interactions with ITSM activities Demonstrate your knowledge of cyber resilience transition, the associated control objectives, and their interactions with ITSM activities Demonstrate your knowledge of cyber resilience operation, the associated control objectives, and their interactions with ITSM activities Demonstrate your knowledge of cyber resilience continual improvement, the associated control objectives, and their interactions with ITSM activities Demonstrate your knowledge of the purpose and benefits of segregation of duties and dual controls Course Introduction Course Learning Objectives Course Agenda Activities Course Book Structure RESILIA Certification Introduction to Cyber Resilience What is Cyber Resilience? Defining Cyber Resilience Balancing in Cyber Resilience Characteristics of Cyber Resilience Risk Management Understanding Risk Management: Discussion Defining Risk Management Addressing Risks and Opportunities Managing Cyber Resilience Why and What of Management Systems? Management Systems Common Management Standards and Frameworks Cyber Resilience Strategy What is Strategy? Cyber Resilience Strategy and Activities Security Controls at Cyber Resilience Strategy Interaction Between ITSM Processes and Cyber Resilience Cyber Resilience Design Why Cyber Resilience Design? Cyber Resilience Design Activities Security Controls at Cyber Resilience Design Aligning ITSM Processes with Cyber Resilience Processes Cyber Resilience Transition Why Cyber Resilience Transition? Basics of Cyber Resilience Transition Cyber Resilience Transition: Controls Interaction Between ITSM Processes and Cyber Resilience Cyber Resilience Operation The Purpose of Cyber Resilience Operation Security Controls in Cyber Resilience Operation Interaction Between IT Processes and Cyber Resilience Interaction Between ITSM Functions and Cyber Resilience Cyber Resilience Continual Improvement Continual or Continuous Improvement Maturity Models Continual Improvement Controls The Seven-Step Improvement Process The ITIL CSI Approach Cyber Resilience Roles & Responsibilities Segregating Duties Dual Controls

This is an intensive installation, commissioning, and maintenance course for emergency lighting systems. It is a follow on from our Foundation course on emergency lighting where the requirements of installation, commissioning, and maintenance are considered.

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face 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 23 Points   Development Level Develop

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