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About this Virtual Instructor Led Training (VILT) Asia Pacific is set to be the largest and fastest growing Hydrogen market globally. This growth is driven by decarbonisation of energy-use, ammonia production and rising demand of fuel cell electric vehicles. Hydrogen as a fuel has outstanding energy carrying capacity and many application possibilities ranging from Petroleum refinery, Ammonia and Methanol production, Transportation and Power generation. Although the current petrochemical market segment will remain strongest in the near future, it is the transport and power sector which spurs the vision of a massive market takeoff in the next decade. The ever-rising share of renewable energies require flexible and scalable storage solutions, which in turn offers many additional revenue streams beyond pure electricity sales. Adding to this the strong impetus towards decarbonization of the transport sector from cars, trucks, trains to ships and even airplanes creates the breed for an exciting and yet untapped market potential. This course aims to clarify and assess the hydrogen business case along its value chain and versatile market applications. Training Objectives Understanding current hydrogen market status and recent developments Major drivers and inhibitors influencing the growth of the market Understanding and comparing various production technology processes Challenges and solutions in transport, distribution and storage of hydrogen Mapping the many petrochemical, energy and transport applications Analyse business cases from around the world and understand their economics Target Audience Project developers Equipment Manufacturers Oil, Gas and Petrochemical sector companies IPPs and utilities Transport sector companies and port operators Policy makers and regulators Investors and lenders Course Level Basic or Foundation Training Methods The VILT will be delivered online in 4 half-day sessions comprising 4 hours per day, including time for lectures, discussion, quizzes and short classroom exercises. Additionally, some self-study will be requested. Participants are invited but not obliged to bring a short presentation (10mins max) on a practical problem they encountered in their work. This will then be explained and discussed during the VILT. A short test or quiz will be held at the end the course. Trainer Your expert course leader is an internationally renowned energy communicator and business educator, focused on the interconnected clean energy transition topics of renewable power, energy storage, energy system electrification and hydrogen. His own independent technology tracking, market assessment and opportunity/risk analysis is delivered to clients through a mix of business advisory work, commissioned content, small-group training (online & in-person), and one-to-one executive coaching (online). In the hydrogen sector, he is currently lead consultant and trainer to the World Hydrogen Leaders network, and writer of their 'This Week in Hydrogen' news column. He is also co-presenter of the 'New Energy Chinwag' podcast, which regularly covers hydrogen-related issues. During more than 15 years as an independent energy expert, he has helped companies from large multinationals to innovative start-ups - totalling assignments in over 30 countries across 5 continents. Most recently, he has presented clean energy training in locations as diverse as Singapore, the UK, South Africa, The Philippines, the USA, Mexico, Spain and Dubai - and, in recent times of course, online to international audiences from across the world. Prior to this, he was Research Director for over 10 years at Informa, a $9 billion business intelligence provider; where he drove new market identification, analysis and project deployment work, and managed teams in the UK and US. He has a strong science background, holding a 1st Class Honours degree in Natural Sciences from the University of Cambridge, a PhD in Earth Sciences and a further Diploma in Economics & Sustainability from the UK's Open University. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information about post training coaching support and fees applicable for this. Accreditions And Affliations

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

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

The aim of this module is to enable delegates to perform entry-type injured person rescue operations, in a Wind Turbine Generator, using industry standard rescue equipment, rescue methods and techniques, exceeding those of GWO Working at Heights. Valid GWO BST Module Working at Heights, GWO First aid and GWO Manual Handling certificates are prerequisites for participation.

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About this Virtual Instructor Led Training (VILT)  This 4 half-day Virtual Instructor Led Training (VILT) course will address a variety of contract and loan structuring issues associated with geothermal energy projects as well as comparison with solar, wind and battery storage. The course is designed to investigate how various project finance techniques and contract structures can be used to achieve a competitive power prices while maintaining a satisfactory equity return. Distinctive project finance features of power facilities that depend on geothermal, wind, hydro or solar resources will be evaluated with financial models. The course will cover economic analysis of exploration and development of geothermal facilities and how to incorporate probability of failure and success into an IRR framework. Subsequent sessions will address the theory underlying liquidated damages for delay, and performance as well as design of other incentives that is inherent in different contract structures. Nuanced project finance issues associated with structuring debt for renewable projects will be discussed including under what conditions the DSCR drives debt capacity and when the debt to capital ratio is instrumental. The course will be taught with a combination of theoretical discussions, term sheet review and focused financial models. Training Objectives Evaluation of the economic risks that arise from uncertainty associated with drilling exploration wells and development wells for geothermal projects. Analyse the theoretical issues with computing LCOE for geothermal projects compared to other renewable and non-renewable resources and the importance of cost of capital for renewable projects; Understand differences in contract structures for renewable projects and dispatchable projects and how a single price structure can distort incentives for efficient construction and operation; Understand components of financing that influence the bid price required to meet a required rate of return on equity and can result in relatively low prices with reasonable returns. Understand the importance of debt sizing constraints and what strategies are relevant when the debt to capital constraint applies relative to when the debt service coverage ratio drives the debt size; Understand how to compute P50, P90 and P99 for different projects driven by resource risk; Understand the difference between mean reverting resource variation and estimation mistakes that do not correct as the basis for 1-year P90 and 10-year P90. Understand under what conditions debt sculpting can affect returns and how synthetic sculpting can be used to increase returns when the DSCR constraint applies. Understand the theory of credit spreads, variable rate debt and interest rates in different currencies and compute the implied probability of default that in inherent in credit spreads. Understand how to evaluate the costs to equity investors and the benefits to lenders for various credit enhancements including DSRA accounts, cash flow sweeps and covenants. Course Level Basic or Foundation Training Methods The VILT will be delivered online in 4 sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day, including time for lectures, discussion, quizzes and short classroom exercises. Trainer Your expert course leader provides financial and economic consulting services to a variety of clients, he teaches professional development courses in an assortment of modelling topics (project finance, M&A, and energy). He is passionate about teaching in Africa, South America, Asia and Europe. Many of the unique analytical concepts and modelling techniques he has developed have arisen from discussion with participants in his courses. He has taught customized courses for MIT's Sloan Business School, Bank Paribas, Shell Oil, Society General, General Electric, HSBC, GDF Suez, Citibank, CIMB, Lind Lakers, Saudi Aramco and many other energy and industrial clients. His consulting activities include developing complex project finance, corporate and simulation models, providing expert testimony on financial and economic issues before energy regulatory agencies, and advisory services to support merger and acquisition projects. Our key course expert has written a textbook titled Corporate and Project Finance Modelling, Theory and Practice published by Wiley Finance. The book introduces unique modelling techniques that address many complex issues that are not typically used by even the most experienced financial analysts. For example, it describes how to build user-defined functions to solve circular logic without cumbersome copy and paste macros; how to write function that derives the ratio of EV/EBITDA accounting for asset life, historical growth, taxes, return on investment, and cost of capital; and how to efficiently solve many project finance issues related to debt structuring. He is in the process of writing a second book that describes a series of valuation and analytical mistakes made in finance. This book uses many case studies from Harvard Business School that were thought to represent effective business strategies and later turned into valuation nightmares. Over the course of his career our key course expert has been involved in formulating significant government policy related to electricity deregulation; he has prepared models and analyses for many clients around the world; he has evaluated energy purchasing decisions for many corporations; and, he has provided advice on corporate strategy. His projects include development of a biomass plant, analysis and advisory work for purchase of electricity generation, distribution and transmission assets by the City of Chicago, formulation of rate policy for major metro systems and street lighting networks, advocacy testimony on behalf of low income consumers, risk analysis for toll roads, and evaluation of solar and wind projects. He has constructed many advisory analyses for project finance and merger and acquisition transactions. Lastly, our key course expert was formerly Vice President at the First National Bank of Chicago where he directed analysis of energy loans and also created financial modelling techniques used in advisory projects. He received an MBA specializing in econometrics (with honours) from the University of Chicago and a BSc in Finance from the University of Illinois (with highest university honours). POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information about post training coaching support and fees applicable for this. Accreditions And Affliations

Performance management, Managing Performance, Employee engagement,

ILM Level 3 Certificate in Leadership & Management – 9 day Accredited training course delivered in Nottingham A course for supervisors and junior managers which brings tangible benefits to the participants and to their organisations through applying the concepts taught at each stage directly to the work environment. The course is assessed in a practical manner through work based assignments for which tutorial guidance is supplied. The course is delivered in an interactive way to appeal to a variety of learning styles and to encourage participation.

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)

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