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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
The course is designed to help improve your understanding of the legal requirements, the theoretical and practical principles for both the initial verification and certification of an electrical installation, further your knowledge and practical skills in the testing and inspection of a range of existing electrical installations, and help improve your understanding of the legal requirements, the theoretical and practical principles for the periodic inspect and testing and certification of an electrical installation.
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Course Overview Lean Six Sigma is a proven combination of tools and techniques that has been used by leading organizations to improve efficiency, productivity and customer satisfaction. It achieves this by providing a rigorous and structured methodology and team approach to problem solving which leads to quality and performance improvements. Our Lean Six Sigma Green Belt training is a seven-day programme which includes an in-house project designed to provide participants with an understanding of the Six Sigma Green Belt Process and it’s practical application. Trainees will enhance their current skills by developing a thorough understanding of the DMAIC (Define/Measure/Analyse/Improve/Control) methodology and its applications, creating a culture of problem solving and continuous improvement in their organization. In this way, key personnel become valuable contributors in achieving the larger goals and objectives of their organization. This powerful tool will enable you and your team to identify opportunities for improvement, and assist in the implementation of projects leading to efficiency by equipping key personnel with the expertise and the tools needed to manage and participate in cost reduction projects with innovative solutions. Trainees will learn how to use data to pinpoint processes that need to be analysed and improved using the Six Sigma Tool sets, with a view to problem solving, increasing operational efficiency, improving productivity and customer satisfaction and the company’s overall business results. Our Lean Six Sigma Green Belt programme incorporates a project to be undertaken in your own organization during and after the training modules. This allows you to apply the tools, in your own working environment, to processes that are known to you, making the training relevant, and also leaving a improvement with measurable results in your organization. MINITAB (trial version can be downloaded free) and Excel software are used by participants during the training sessions and to complete their projects. Structure of the Course This 7-day training programme is divided into three modules as follows: Define / Measure Phase - 3 days from Nov 25th to 27th, 2024 Analyse Phase - 2 days on January 13th &14th, 2025 Improve / Control Phase - 2 days on February 17th & 18th, 2025 A gap of 4 weeks between each module provides an opportunity for trainees to work on a project within their workplace, applying the methodology and tools learned during the previous module. Extra support can be provided between modules for each trainees with their project work. We provide a Lean Six Sigma Green Belt Manual for all delegates, and a Certification is awarded upon completion of the Green Belt training and ONE project by each trainee in which the targeted outcomes have been achieved. An outcome report and/or project presentation which demonstrates the use of the tools and methodology is required. Cost: £1,800 + VAT per person. What is included Seven days of face-to-face training delivered in 3 modules as listed above Project review and support for all participants during modules 2 & 3. Remote support available for the duration of the programme for trainees to consult with the trainer. All training material, and a Lean Six Sigma Green Belt Manual for all delegates Refreshments and lunch provided each day of training Free car park for all delegates Lean Six Sigma Green Belt certificate In-house Option This workshop can also be delivered in-house as a stand-alone training workshop or integrated into wider improvement activities. Contact us for more details at compete@cforc.org and we will be happy to discuss in the context of your own business needs. If you are not yet a member but are already thinking about joining CforC, you can find more information on how to become a member and the benefits by clicking here.
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Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 19 Points Development Level Develop
This GRI, IEMA & CPD course is geared for busy professionals who want to understand how to proceed and create a 1st Class GRI Standards Sustainability Report and have a plan for immediate sustainability action without wasting time.
Lean Six Sigma Green Belt Certification Program - Become Green Belt Certified: On-Demand This course explores the DMAIC process in depth and enables you to achieve IIL's Lean Six Sigma Green Belt Certification. DMAIC is the foundation of Lean Six Sigma and process improvement. The incremental steps of "Define, Measure, Analyze, Improve, Control" give structure and guidance to improving quality, performance, and productivity. Green Belt is not just a role, it is also a competency required for leadership positions at many top companies. This learning series is designed to enable participants to fulfill the important role of a Lean Six Sigma Green Belt and to incorporate the Lean Six Sigma mindset into their leadership skills. With a real-world project focus, the series will teach the fundamental methodology, tools, and techniques of the Define, Measure, Analyze, Improve and Control Process Improvement Methodology. What You Will Learn At the end of this program, you will be able to: Identify strategies for effectively leading high performing process improvement teams Analyze whether projects align with business strategy Apply process improvement methodologies to DMAIC steps, based on real world scenarios Explain ways to appropriately respond to process variation Distinguish among best practice problem solving methodologies Evaluate and effectively communicate data-driven decisions, based on real world scenarios Introduction Lean Six Sigma & quality The vision The methodologies The metric Project Selection Why Projects Random idea generation Targeted idea generation CTQs (Critical to Quality) & projects Project screening criteria Quick improvements Introduction to Define Project Planning Developing the core charter Developing a project charter Facilitation Process Management Business process management Top-down process mapping Voice of the Customer Voice of Customer Stakeholder analysis Communication planning Kicking off the project Introduction to Measure Data Collection Fact-based decision making Data sampling Operations definitions Data collection plan Measurement system analysis Graphical Statistics for Continuous Data Meet Six SigmaXL Graphical & statistical tools Data stratification Graphical Statistics for Discrete Data Pareto analysis Dot plots Plotting data over time: Looking for patterns Variation Concepts Variation is reality Special Cause and Common Cause variation Example of standard business reporting Individuals Control Chart Process Capability Genesis of process capability Calculating the metrics of Six Sigma Yield metrics: Measuring process efficiency Cost of Poor Quality The Cost of Poor Quality (COPQ) Cost of Quality categories Calculating the Cost of Poor Quality Introduction to Analyze Process Analysis Introduction to process analysis Value-added analysis Cycle time analysis WIP & pull systems Analyzing bottlenecks and constraints Cause & Effect Analysis Fishbone/Ishikawa diagram 5-Whys analysis Graphical & statistical tools Advanced Analysis Why use hypothesis tests? Hypothesis tests Correlation and regression analysis Introduction to Improve Solutions Creativity techniques Generating alternative solutions Solution selection techniques Introduction to Design of Experiments Introduction to DOE DOE activity Error Proofing Failure mode & effect analysis Poka-Yoke Project Management Fundamentals Successful teams Project roles Conflict management Standardization Standardization The Visual Workplace 5S Piloting & Verifying Result What is a pilot? Evaluating results Introduction to Control Statistical Process Control Review of Special & Common Cause variation Review of Individual Control Chart P-Chart for discrete proportion data Transition Planning Control plan Project closure