11304 Courses

Management of Portfolios (MoP®) Practitioner In this MoP® Practitioner course, participants will have sufficient knowledge and understanding of how to apply and tailor the MoP guidance and to analyze portfolio data, documentation, and roles in relation to a given situation. MoP helps organizations ensure if the investments are done in the right, change initiatives, and implementing them correctly. This is achieved by: Prioritizing the programs and projects in terms of their contribution to the organization's strategic objectives and overall level of risk Managing the programs and projects consistently to ensure efficient and effective delivery Maximizing the benefit by providing the greatest return from the investment made What you will Learn Define the business case to get senior management approval for portfolio management Plan the implementation of portfolio management Select and adapt MoP principles, practices, and techniques to suit different organizational environments Evaluate examples of MoP information including documents and role descriptions Analyze the solutions adopted in relation to a given scenario Introduction Overview MoP Portfolio Definition Portfolio Management Roles Portfolio Management Documents MoP Practitioner Assignments Portfolio Management Documents Portfolio Delivery How to Implement Practice Exam MoP Practitioner Exam (taken online, after the class has ended)

Portfolio, Programme, and Project Offices (P3O®) Practitioner P3O® is the AXELOS standard for the design of decision-making processes regarding changes in organizations. P3O provides a guideline for the design of portfolio, programme, and project offices in organizations. The P3O Practitioner Course is an interactive learning experience. The P3O Practitioner-level content provides you with sufficient knowledge and understanding of the P3O guidance to design, implement, manage or work within any component office of a P3O model. It enables participants to successfully complete the associated P30 Practitioner exam and achieve the qualification. In this course, you will be prepared to successfully attempt the P3O Practitioner exam and learn how to implement or re-energize a P3O model in their own organization. What you will Learn At the end of the P3O Practitioner course, you will be able to: Define a business case to get senior management approval for P3O Build a right P3O model to adapt to the organization's needs, taking account of the organization's size and portfolio, programme and project management maturity Identify the elements, roles, and functions deployed in a generalized P3O model Use tools and techniques in running the P3O and advising those who shape the portfolio of programmes and projects Introduction to P3O What is the purpose of P3O? Definitions What are P3Os? Portfolio, programme, and project lifecycles Governance and the P3O Designing a P3O Model Factors that affect the design Design considerations What functions and services should the P3O offer? Roles and responsibilities Sizing and tailoring of the P3O model Why have a P3O? How a P3O adds value Maximizing that value Getting investment for the P3O Overcoming common barriers Timescales Why have a P3O (Extension)? The P3O Business Case The P3O Model Blueprint Vision Statement Demonstrating the Value KPIs The Benefits of Claimed Capabilities Benefit Realisation and Strategic Objectives Benefit Profile How to Implement or Re-Energize a P3O Implementation lifecycle for a permanent P3O Identify Define Deliver Close Implementation lifecycle for a temporary programme or project office Organizational context Definition and implementation Running Closing Recycling How to operate a P3O Overview of tools and techniques Benefits of using standard tools and techniques Critical success factors P3O tools P3O techniques

Management of Value (MoV®) Foundation This interactive MoV® Foundation course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn Upon completion of an MoV course candidates should be able to discuss and explain: The main processes and techniques used within MoV and the reasons for using them How MoV may be applied at portfolio, program, project and operational levels The differences in applying MoV at different stages in a project and the expected outputs from a MoV Study at each stage The circumstances under which MoV should be used The concept of value and how value may be improved The main benefits arising from the use of MoV Approaches for implementing MoV How to respond to external and internal influences The principles of embedding MoV into an organization The key topics in document checklists, the toolbox, health check, organizational maturity and individual competence. Upon successful completion of this course, you will be able to: Organize and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach and environment Analyse a company, program or project to establish its organizational value; includes identification and weighting of Value Drivers Pass the AXELOS MoV Foundation Examination Introduction to value management and MoV Value and Value Management Capabilities, Outcomes, Benefits and Disbenefits What is Value? What is Management of Value (MoV)? Why use MoV? Where use MoV? When MoV should be used? What using MoV involve? Selected MoV benefits Relationship with other AXELOS Global Best Practices and Models How MoV fits with other AXELOS Global Best Practice Guides MoV principles Align with organization's objectives Focus on functions and required outcomes Balance the variables to maximise value Apply throughout the investment decision Tailor MoV to suit the subject Learn from experience and improve Assign clear roles and responsibilities and build a supportive culture MoV processes Frame the programme or project Gather information Analyse information Process information Evaluate and select Develop Value Improving Proposals Implement and share outputs MoV techniques Function Analysis Function Analysis System Technique (FAST) Traditional (or classic) FAST Technical FAST Customer FAST Value Trees Measuring value Value profiling (a.k.a. value benchmarking) Simple multi-attribute rating technique (a.k.a. SMART) Value index Value metrics Value for money (VfM) ratio Value Engineering / Analysis Common techniques used in MoV Analysis of information Benchmarking Process Mapping Root Cause Analysis Discounted Cash Flow Analysis Generating Ideas Brainstorming Evaluation and option selection Option Selection Matrix Idea selection Allocation to Categories Idea Selection Matrix Weighting techniques Paired Comparisons Points Distribution Developing VIPs Developing Proposals Cost Benefit Analysis Building Decisions Implementing VIPs Implementation Plans Feedback Following up Tracking Benefits Approach to Implementation Generic approach to MoV implementation Plan the MoV activities Understand and articulate value Prioritize value Improve value Quantify value Monitor improvements in value Learn lessons Environmental factors Portfolio Considerations Programme considerations Project considerations Operational Considerations Embedding MoV into an organization Benefits of Embedding MoV into an organization MoV Policy MoV Policy Composition Embedding MoV into an organisation Key steps Suggested MoV Management Structure Overcoming barriers We do it anyway It takes up too much time We can't afford to make the changes What's in it for me? Don't fix it if it ain't broke Fixed returns on investment MoV products Briefing Meeting Agenda (A.1) Communications Checklist (A.2) Equipment list for an Effective Study/Workshop (A.3) Invitation to join the Study Team (A.4) Option Evaluation Matrix (A.5) Plan the Study (A.6) Recording Idea Selection (A.7) Reporting Study outputs (A.8) Scoping the Study (A.9) Study or Workshop Handbook (A.10) Value-Improvement Proposal Forms (A.11) Value Improvement Tracking Report (A.12) MoV toolbox MoV health check and maturity model P3M3 Maturity Model MoV Maturity Model (aligned with P3M3)

Better Business Cases™ Practitioner 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 practitioner course is to develop a candidate's ability to deliver a comprehensive business case, through encouraging expanded knowledge to guide the practical application of theoretical foundations. Upon the completion of this Practitioner course, a candidate will be able to start applying the model to a real business case development project. What You Will Learn At the end of this program, you will be able to: Develop the lifecycle of a business case and to establish the relationships between the five cases Apply the steps in the business case development framework, in order to support the production of a business case, using the Five Case Model, for a given scenario Overview of Better Business Cases Alignment with the strategic planning process Importance of the Business Case using the Five Case Model Overview of the Five Case Model Purpose of the key stages in the development of a spending proposal Purpose of a Business Justification Case Business Case Development Process Purpose of project / programme assurance and assurance reviews Responsibility for producing the Business Case Determining the Strategic Context and Undertaking the Strategic Assessment Scoping the Scheme and Preparing the Strategic Outline Case Planning the Scheme and Preparing the Outline Business Case Procuring the Solution and Preparing the Full Business Case Implementation and monitoring Evaluation and feedback Making the Case for Change Agree on the strategic context Determine spending objectives, existing arrangements, and business needs Determine potential business scope and key service requirements Determine benefits, risks, constraint, and dependencies Exploring the Preferred Way Forward Agree on critical success factors Determine long list options and SWOT analysis Recommend a preferred way forward Determining Potential Value for Money Revisit the short list Prepare the economic appraisal for short-listed options Undertake benefits appraisal Undertake risk appraisal Select preferred option and undertake sensitivity analysis Preparing for the Potential Deal Determine the procurement strategy Determine service streams and required outputs Outline potential risk apportionment Outline potential payment mechanisms Ascertain contractual issues and accountancy treatment Ascertaining Affordability and Funding Requirement Prepare the financial model Prepare the financial appraisals Planning for Successful Delivery Plan programme / project management Plan change and contract management Plan benefits realization Plan risk management Plan programme / project assurance and post project evaluation Procuring the Value for Money Solution Revisit the case for change Revisit the OBC options Detail procurement process and evaluation of best and final offers (BAFOs) Contracting for the Deal Set out the negotiated deal and contractual arrangements Set out the financial implications of the deal Ensuring Successful Delivery Finalize project management arrangements and plans Finalize change management arrangements and plans Finalize benefits realization arrangements and plans Finalize risk management arrangements and plans Finalize contract management arrangements and plans Finalize post-project evaluation arrangements and plans

Level Three, the final learning stage of our professional development courses, aims to bring you to the highest standard of advanced detailing skill through the spectrum of; rotary polisher techniques, wet sanding by machine and refinement, a full understanding of SMAT and DAT polishes and compounds and their role in efficiency and correction on different paint types, a wide selection of pads and equipment such as nano polishers and attachments. Mechanical training in wheel removal and jacking on multiple vehicle styles allowing deep cleaning access to vehicle arch and components, and specialist finishes on carbon fibre, GRP and gel coat are examined, demonstrated and explained. Level Three aims to bring you to the highest standard of advanced detailing skill, through the spectrum of rotary polisher techniques, wet sanding by machine, a full understanding of SMAT and DAT polishes and compounds, a wide selection of pads and equipment such as nano polishers and attachments. Mechanical training in wheel removal and jacking on multiple vehicle styles allowing deep cleaning access to vehicle arch and components, and specialist finishes on carbon fibre, GRP and gel coat are examined and explained. • DAT/SMAT technology • Pneumatic polishers and sanders • Advanced Dual Action technique • Rotary machine polishers • Glass polishing • Wheel removal • Under-arch cleaning • Cleaner chemistry • Time management and planning • Trim and seat removal • In-depth interior detailing • Cloth types • Advanced Dual Action technique • Rotary machine polishers • Mini/nano machine polishers • Wet-sanding • Advanced pad types • GRP, carbon and insulative substrates • Badge and trim removal • Texture levelling • Show preparation • Ceramic coatings • Polymer coatings • Coating troubleshooting • Coatings after-care • Fillers and glazes for show finishes • Business management • Business administration • Safe working practices • Safe vehicle lifting - ramp/jacking • Workshop planning • Advanced chemical knowledge • Risk assessments • Gloss meter usage • PPE • Employee management Following completion of training and ongoing assessment, case studies and exercises will lead to the level three exam and, upon grading, award of our advanced detailing Level 3 Detailing. Course Length 3 Days (0930 - 1600) Group Size One-to-One Location UK Detailing Academy, 2 Purlieus Barn, Ewen, Cirencester, GL7 6BY Experience / Qualification Completion of Level 2 Refreshments or Lunch Refreshments included

Launch your Detailing Career. Are you looking to launch a detailing career and need to start on the right foot? Level One is ideal for those just about to enter the detailing industry, or those who wish to reset, update and refresh their skills. The aim is to teach you the foundations of vehicle care from assessment up to entry-level machine polishing, to have a successful and reputable business from the very start. Business practices and health and safety are explored covering areas such as pricing, marketing, target clientele, SDS and environmental conformity. This is much more than just a 'how to wash a car'. It gives your new detailing business the best possible start, optimising it for success and backed with a resource for any issues you may encounter. Complete course guide book, ongoing support and certification exam fee are all included in the cost. The Level 1 Course is available as either this standard vehicle course or alternatively a motorbike-focused course. You can also book the Level 1 + Motorbike course as a bolt-on day, if you wish to cover both aspects and open your target market even further.   Available start dates are highlighted in the calendar below, all days are one-to-one so can be booked to suit your schedule. The aim of Level One is ideal for those just about to, or have recently entered the detailing industry, or those who wish to reset and refresh their skills. the aim is to familiarise the candidate with the processes and maintenance of vehicles from a professional and business view, teaching the foundations of correct vehicle cleaning up to the final familiarisation of entry-level dual action machine polishers. Business practices and health and safety are explored covering areas such as pricing, marketing, SDS and environmental conformity. The Level 1 Course is available as either a car or motorcycle course. Alternatively, candidates can book an additional day on Motorcycle Detailing as a bolt-on to an automotive Level 1 Course here. Modules covered on the course are: Washing stages Wash media Environmental considerations Drying methods Bonded contamination and its removal Wheel care and maintenance Glass and hard surfaces Engine bay cleaning Vulnerable surfaces Efficiency and process PPE and safety Clothing and working practices Risk assessment Chemical knowledge Van set-ups Interior detailing Leather and soft surface care Fillers/glazing Dual action machine polishers intro Minor defect identification Paint types LSPs Final presentation Marketing Conflict resolution and customer care Financing Insurance Pricing and quotes Business Administration Memberships Social Media Manual handling Safe working practices Pre-work inspection All levels are accompanied by a full course booklet to jog your memory when needed. Practical assessment takes place as part of the original training session, at the end of the course you will be assigned a (manageable) series of case studies and exercises to complete over 3 months to cement the knowledge. There is then a short externally assessed exam before the optional commencement of Level Two, to ensure there are no weak areas. After which the Level One accreditation is awarded and you can either progress or choose to practice the skills gained with ongoing support. Course Length 3 Days (0930 - 1600) Group Size One-to-One Location UK Detailing Academy, 2 Purlieus Barn, Ewen, Cirencester, GL7 6BY Experience / Qualification Open to all Refreshments or Lunch Refreshments included

Launch your Detailing Career. Level One Motorbike is ideal for those just about to enter the detailing industry, or those who wish to reset, update and refresh their skills. The aim is to familiarise the candidate with the processes and maintenance of vehicles from a professional and business view for a new detailing career, teaching the foundations of correct vehicle cleaning up to the final familiarisation of entry-level dual-action machine polishers. Business practices and health and safety are explored covering areas such as pricing, marketing, target clientele, SDS and environmental conformity. This is much more than just a 'how to wash a vehicle' course, and gives your business the best possible start, optimising it for success.   The aim of Level One Motorbike is ideal for those just about to, or have recently entered the motorbike detailing industry, or those who wish to reset and refresh their skills with a focus exclusively on motorbikes. The aim is to familiarise the candidate with the processes and maintenance of two-wheeled vehicles from a professional and business view, teaching the foundations of correct vehicle cleaning up to the final familiarisation of entry-level dual-action machine polishers. Business practices and health and safety are explored covering areas such as pricing, marketing, SDS and environmental conformity. The Level 1 Course is available as a motorbike focused, or alternatively our standard vehicle course. Alternatively, candidates can book an additional day on Motorcycle Detailing as a bolt-on to an automotive Level 1 Course here if they would like to learn both sets of skills. Along the way topics covered will be: Washing stages Wash media Environmental considerations Drying methods Bonded contamination and its removal Wheel care and maintenance Glass and hard surfaces Engine bay cleaning Vulnerable surfaces Efficiency and process PPE and safety Clothing and working practices Risk assessment Chemical knowledge Van set-ups Interior detailing Leather and soft surface care Fillers/glazing Dual action machine polishers intro Minor defect identification Paint types LSPs Final presentation Marketing Conflict resolution and customer care Financing Insurance Pricing and quotes Business Administration Memberships Social Media Manual handling Safe working practices Pre-work inspection All levels are accompanied by a full course booklet to jog your memory when needed. Practical assessment takes place as part of the original training session, at the end of the course you will be assigned a (manageable) series of case studies and exercises to complete over the period of 3 months to cement the knowledge. There is then a short externally assessed exam prior to the optional commencement of Level Two, to ensure there are no weak areas. After which the Level One accreditation is awarded and you can either progress or choose to practice the skills gained with ongoing support. Course Length 3 Days (0930 - 1600) Group Size One-to-One Location UK Detailing Academy, 2 Purlieus Barn, Ewen, Cirencester, GL7 6BY Experience / Qualification Open to all Refreshments or Lunch Refreshments included

Embark on a transformative journey with Kranti Yoga's 100-Hour Workshop, a soul-enriching experience designed to deepen your understanding of yoga, nurture self-discovery, and enhance overall well-being. Whether you're a seasoned practitioner or a novice, this immersive workshop invites you to explore the profound teachings of yoga in a supportive and tranquil environment.

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