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
Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud and corruption.
This module aims to develop knowledge from research activities to gain an understanding of international trade theory, global economic development and growth, currency and exchange rates, trade policies and their impact on an organisation, free trade agreements, direct investment from financial sources outside the UK, tariffs and no trade barriers, supply chain and logistics, intercultural management and international law and treaties.
Are you really passionate about film? Do you want to get your hands on the kit used to make real films? Do you want to learn your craft from real filmmakers? Screen and Film School is dedicated to one thing: Film. The BA (Hons) Filmmaking is focused on creating the next generation of filmmakers.
This module aims to develop knowledge from research activities to gain an understanding of international trade theory, global economic development and growth, currency and exchange rates, trade policies and their impact on an organisation, free trade agreements, direct investment from financial sources outside the UK, tariffs and no trade barriers, supply chain and logistics, intercultural management and international law and treaties.
This module aims to develop knowledge and understanding of the status of an authorised economic operator in the export and in import of goods. This includes the advantages of the status, trusted trader, and the process securing the authorised economic operator status.
About this Training Course This intermediate to advanced level 3 full-day training course has been designed to provide participants with a detailed and up-to-date overview of the fluid mechanic fundamentals and operating practice of pumps, compressors and gas and steam turbines. Upon the successful completion of this course, participants will have acquired the practical knowledge to enable them not only to choose the correct device for a particular application but also be in a position to resolve many commonly occurring operating problems. Troubleshooting is an important part of this course and will cover the important topics of Machinery Root Cause Failure Analysis (RCFA) together with Vibration Analysis. This course is ideal for those personnel in the oil, gas, petrochemical, chemical, power and other process industries who require a wider and deeper appreciation of pumps, compressors and turbines, including their design, performance and operation. The participants will be taken through an intensive primer of turbo-machinery principles, using the minimum of mathematics, and will learn how to solve the many and varied practical industrial problems that are encountered. The course makes use of an extensive collection of VIDEO material together with case studies and numerical exercises. Training Objectives Upon the successful completion of this course, each participant will be able to: Apply a comprehensive knowledge of pumps, compressors & turbines and troubleshoot rotating equipment in a professional manner Identify the different types of turbomachinery including basic design aspects and highlighted problem areas Minimise compressor work by understanding the processes involved and identifying their efficiency Understand the flow through turbomachines and the corresponding velocity triangles including torque and power calculations Analyse the different types of centrifugal machines including their design, installation, operation, maintenance, re-rate/retrofit, troubleshooting and control Recognise the various beneficial design aspects of turbomachines and understand the crucial process of cavitation Carry out proper methods of device installation, operation, maintenance and troubleshooting Understand and apply the powerful methods of Machinery Root Cause Failure Analysis Understand the various methods of vibration analysis applied to device diagnostics Target Audience This course provides an overview of all significant aspects and considerations of pumps, compressors and turbines for those who are involved in the design, selection, maintenance or troubleshooting of such equipment. This includes maintenance, reliability, integrity, engineering, production and operations managers, engineers and other technical staff. Course Level Intermediate Advanced Trainer Your expert course leader is a Senior Mechanical & Instrumentation Engineer (UK, B. Sc., M.Eng., Ph D) with over 45 years of industrial experience in Process Control & Instrumentation, Pumps, Compressors, Turbines and Control Valve Technology. He is currently a Senior Independent Consultant to various petrochemical industries in the UK, USA, Oman, Kuwait and KSA where he provides consultancy services on both the application and operational constraints of process equipment in the oil & gas industries. During his early career, he held key positions in Rolls Royce (UK) where he was involved in the design of turbine blading for jet engines, subject to pre-specified distributions of pressure. During this period and since, he has also been closely involved in various aspects of Turbomachinery, Thermodynamics and Fluid Mechanics where he has become a recognised authority in these areas. Later, he joined the academic staff of University of Liverpool in the UK as a Professor in Mechanical Engineering Courses. A substantial part of his work has been concerned with detailed aspects of Flowmetering - both of single & multiphase flows. He has supervised doctoral research students in this area in collaboration with various European flowmeter manufacturers. He joined Haward Technology Middle East in 2002 and was later appointed as European Manager (a post which has since lapsed) and has delivered over 150 training courses in Flowmeasurement (single- and multi-phase), Control, Heat Exchangers, Pumps, Turbines, Compressors, Valve and Valve Selection as well as other topics throughout the UK, USA, Oman and Kuwait. During the last two years, he has delivered courses with other training companies operating in the Far and Middle East. He has published about 150 papers in various Engineering Journals and International Conferences and has contributed to textbooks on the topics listed above. 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 post training support and fees applicable Accreditions And Affliations
About this Training Course This course will begin with a presentation of topics to familiarize Process and Instrumentation Engineers with procedures and practices involved in the choice of sensors related to the measurement of temperature, pressure, level and flow in relation to single-phase flows. It will provide guidance on the optimum commercially available devices through a detailed comparison of their relative merits. At the heart of this course is sensor calibration which is a crucial element for these topics. The course will also examine the various types of flow control valve, including Globe, Slide, Needle, Eccentric plug and Ball valves and their characteristics in industrial application, while focusing on the problems of Cavitation and Flashing and methods to minimise or eradicate these issues. With the use of examples, industry case studies and a wide range of videos, this course will also cover all aspects of proportional (P), derivative (D) and integral (I) control. In particular, it will address the advantages and disadvantages of PI and PID control. It will also describe Cascade, Feed forward, Split Range, Override and Ratio Control techniques. Training Objectives By attending this course, participants will acquire the following knowledge and skills: Apply an in-depth knowledge to the measurement of temperature, pressure, level and flow as well as to the fluid mechanics of pipe flows Assess the advantages and disadvantages of the major flowmeter types including the differential pressure, rotary positive displacement, rotary-inferential, electromagnetic, ultrasonic and Coriolis mass flowmeters to determine the optimum choice for a given application Make a considered judgement of the choice of fluid level measurement devices Understand the various types of flow calibration, metering systems and provers Carry out tank measurement and tank calibration methods and to calculate net sellable quantities Discuss valve characteristics & trim selection and illustrate the process of control valve sizing Explain the terms Open and Closed loop Define Process Variable, Measured Variable, Set Point and Error Define Direct and Reverse controller actions Explain the terms Process Lag, Measurement Lag, Transmission Lag, and Response Lag and their effect on controllability Explain ON/ OFF Control and the inherent disadvantages Explain Proportional Control, Offset, Gain and Proportional Band and the advantages and disadvantages of Proportional only control Explain the fundamentals and operation principles of Integral (I) Action and the disadvantages of proportional plus integral control Explain the fundamentals and operation principles of Derivative (D) Action in conjunction with P action Describe the operating principles of a PID Controller and explain the applications and advantages of PID control Describe Cascade, Forward, Split Range and Ratio Control operation principles Target Audience This course will benefit instrumentation, inspection, control, custody metering and process engineers and other technical staff. It is also suitable for piping engineers, pipelines engineers, mechanical engineers, operations engineers, maintenance engineers, plant/field supervisors and foremen and loss control coordinators. Trainer Your expert course leader is a Senior Mechanical & Instrumentation Engineer (UK, B. Sc., M.Eng., Ph D) with over 45 years of industrial experience in Process Control & Instrumentation, Pumps, Compressors, Turbines and Control Valve Technology. He is currently a Senior Independent Consultant to various petrochemical industries in the UK, USA, Oman, Kuwait and KSA where he provides consultancy services on both the application and operational constraints of process equipment in the oil & gas industries. During his early career, he held key positions in Rolls Royce (UK) where he was involved in the design of turbine blading for jet engines, subject to pre-specified distributions of pressure. During this period and since, he has also been closely involved in various aspects of Turbomachinery, Thermodynamics and Fluid Mechanics where he has become a recognised authority in these areas. Later, he joined the academic staff of University of Liverpool in the UK as a Professor in Mechanical Engineering Courses. A substantial part of his work has been concerned with detailed aspects of Flowmetering - both of single & multiphase flows. He has supervised doctoral research students in this area in collaboration with various European flowmeter manufacturers. He joined Haward Technology Middle East in 2002 and was later appointed as European Manager (a post which has since lapsed) and has delivered over 150 training courses in Flowmeasurement (single- and multi-phase), Control, Heat Exchangers, Pumps, Turbines, Compressors, Valve and Valve Selection as well as other topics throughout the UK, USA, Oman and Kuwait. During the last two years, he has delivered courses with other training companies operating in the Far and Middle East. He has published about 150 papers in various Engineering Journals and International Conferences and has contributed to textbooks on the topics listed above. 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 post training support and fees applicable Accreditions And Affliations
About this Training Course Exploration and production technology, equipment specification and processes have a unique language that must be conquered by executives such as you. A confident understanding of the technical jargon and a visual appreciation of the various pieces of equipment used provides for an overall 'big picture' of industry value chain. This serves as an excellent foundation for smooth communication and increased efficiency in inter-department project team efforts. Gain a comprehensive overview of the entire value chain and process of oil & gas upstream operations and business in this 3 full-day training course. Training Objectives By attending this industry fundamentals training course, participants will be better able to: Appreciate the dynamics of world energy demand & supply and its impact on pricing Understand the formation of petroleum reservoirs and basic geological considerations Examine the exploration process to gain an overview of the technical processes involved Gain a comprehensive overview of drilling activities - from pre-drilling preparation, through to well drilling, well evaluations and post drilling activities Get familiarised with the common production methods and the different stages of its processes Integrate your understanding of asset maintenance and downstream supply chain activities Better visualise through video presentations the various exploration equipment/ technologies and understand the major cost components Target Audience This course will be useful and applicable, but not limited to: Accounting Administration Business Development Commercial Construction E & P IT / Data Finance Finance & Treasury Health & Safety Human Resource Joint Venture Co-ordinators Legal Logistics Materials Planning Procurement Sales & Marketing Senior Management Sourcing Strategic Planning Supply Chain Tender Contract Course Level Basic or Foundation Training Methods Multi-media presentation methodology to enable better understanding and appreciation technical jargon and equipment applied in the field A pre-course questionnaire to help us focus on your key learning objectives Detailed reference manual for continuous learning and sharing Limited class size to ensure one to one interactivity Trainer Your expert course leader worked for BP for 28 years as a Research Associate and Team Leader, working on Feasibility Studies and acting as a trouble shooter covering all aspects of BPs businesses. These covered field Development Project in the North Sea and several novel resource recovery techniques which were taken from Concept to Field Pilot trials in Canada. His specific work in the offshore area covered Subsea Robotics / Automation, Seabed Production Concepts, Seabed Excavation Methods, Underwater Repair Techniques, Flexible Riser Studies and Maintenance Cost Reductions. After leaving BP in 1992, he continued working in the offshore oil industry through Azur Offshore Ltd, including activities in the assessment of Emerging and Novel Technologies, Technical and Economic Audits, Studies, Production Sharing Agreement Evaluations, Safety and Environmental issues. Clients have included Chevron UK, BP Exploration, British Gas, Technomare, Trident Consultants, Fina UK and Cameron France. He is a regular University lecturer at Crandfield School of Industrial Sciences (UK) and is a course Group Project external examiner for Crandfield. He also lectures on offshore oil industry activities at ENSIETA (France), the Technical University of Delft (Holland) and the Northern Territories University in Darwin (Australia). He is an active member of the UK Society for Underwater Technology (SUT) and serves on their Subsea Engineering and Operations Committee. 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 post training support and fees applicable Accreditions And Affliations
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