286 CLO courses in Manchester

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 Virtual Instructor Led Training (VILT) Preventive and Predictive maintenance are not new concepts. Both have been used across industry all over the world and when done properly, can yield impressive results (cost reductions of 20% or greater and a leap forward in equipment reliability and performance are very achievable). However, for every company using these concepts effectively, there are many others who are not. This 8 half-day Virtual Instructor Led Training (VILT) course has been derived from the Plant Performance Improvement Road Map developed by practitioners that guarantee the reliability of your operations. The VILT training focuses on how to improve profitability of any business by identifying the right maintenance strategy for any equipment. The aim of the VILT training is to help practitioners run programmes that will deliver real benefits as fast as possible with minimum zero wasted effort. The VILT training will also cover the core principles of Reliability Centred Maintenance, Total Productive Maintenance and Six Sigma and the increasingly important role of operations in achieving optimised asset performance. This is a certified course with the option of sitting for a short exam on the final day of the course to give participants the opportunity to gain a Certificate from petroEDGE and the Carcharodon Maintenance Academy. Training Objectives Master the critical skills by acquiring the following: An understanding of how maintenance can add profit The ability to develop improvement programmes that deliver maximum benefit in the shortest time A fundamental understanding of the principles of Preventive, Predictive and other maintenance types A practical understanding of the latest methods of solving problems at root cause level An appreciation of maintenance methodologies such as Reliability Centred Maintenance Strategies for ensuring your company gets value for money from your Contractors How to use the Maintenance Model of Excellence and Plant Performance Improvement Road Map Target Audience This VILT course has been designed for maintenance managers and engineers, reliability professionals, planners, project engineers, operations team members, and functional specialists. Training Methods The VILT course will be delivered online in 8 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. Course Duration: 8 half-day sessions, 4 hours per session (32 hours in total). Trainer Your expert course leader is an award-winning consultant and trainer with 30 years' experience in maintenance and reliability improvement. He has worked across five continents, in a wide variety of environments from the world's largest oil refinery to a small drinks production line. He has 10 years of maintenance management experience in the process industry, so he brings a very practical approach to training. He moved into consulting with ABB Eutech as their global maintenance specialist where he led maintenance and reliability best practice panels, delivered a wide range of maintenance improvement projects and trained other consultants. He is a fully qualified CMRP professional, an approved SMRP* Proctor, authorised to conduct CMRP exams and a globally respected maintenance consultant and best practice trainer. He founded his consultancy and training business in 2002 to focus on maintenance and reliability improvement. As part of this, he developed a range of maintenance 'models of excellence' with inputs from authors, international lecturers and some of the world's leading consultants and operators. His work has been recognised as being at the leading edge of industry best practice, winning independent awards such as the UK Chemical Industries Association 'Excellence in Engineering' award. He remains close to the industry as a respected specialist helping operating companies to achieve changes in performance. This ongoing field work enables him to continue to refine and extend best practice and the learning from this is continually fed into his training. His unique experience of facilitating two major turnarounds when the Coronavirus escalated into lockdown have given him a unique insight into how events of this type can disrupt maintenance. Moreover, his involvement in developing management processes and leading a Coronavirus response on a major industrial asset means he can talk with direct experience about how to cope and innovate in this global pandemic. *SMRP refers to Society of Maintenance and Reliability Professionals. PetroEdge is not affiliated with SMRP 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

About this Virtual Instructor Led Training (VILT) A large amount of geological data is acquired at a substantial cost when carrying out a drilling operation. Ensuring optimal quality of this information and effective reporting plays a key role during well design and drilling operations. In addition, there is much to benefit from the later usage of the data in field studies. A critical component that ensures favourable and positive results is the close co-operation between geological, drilling and well engineering departments. Comprising 5 half-day sessions, this Virtual Instructor Led Training (VILT) course aims to provide the required knowledge in order for the collaboration to be most effective and successful. This VILT course will comprise lectures interspersed with practical and interactive exercises and quizzes to promote better understanding. Training Objectives At the end of this VILT course, participants will be able to: Understand the techniques used by wellsite geologists in formation evaluation via: Quick-look analysis to assess reservoir and hydrocarbons Mudlog data (lithology/cutting description, gas readings) Grasp the application of wellsite data in exploration and development Be able to read, assess and use drilling reports Acquire an understanding of drilling problems caused by subsurface conditions Understand the role and contributions of the geologist to the well maturation process Target Audience This VILT course is intended for geologists and other subsurface staff involved in drilling operations who would like to work and communicate more effectively with wellsite staff.  Please note that this VILT course is not a preparation course for a wellsite assignment. To be able to work independently on the wellsite, a more hands-on or on-site training would be required. Training Methods This VILT course will be delivered online in 5 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. Course Duration: 5 half-day sessions, 4 hours per session (20 hours in total). Trainer Your expert course leader has close to 20 years of experience as a geologist in the Oil & Gas industry. Her main interest and passion is in well planning and operations. She had previously worked as a production geologist and technical authority in NAM (Netherlands), and as a discipline advisor tasked to coach young staff in Bangalore. She has been active in internal training sessions on drilling hazards, mudwindow assessment and project management. She obtained an MSc in hard rock structural geology from the University in Utrecht, a PhD at Brown University (RI, USA) and a post-doctoral at the RWTH Aachen. 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

About this Training Front End Loading (FEL) is a methodology that takes a deliberate approach to capital project planning. Where traditional project plans seek to help an operator reach production targets and budgets, FEL methodology aligns an operator's technical and business goals to create a more comprehensive development plan. The FEL approach increases project definition and lowers risk to positively impact total investment costs and return on investment. Training Objectives Upon completion of this course, participants will be able to: Learn the methods applied for Pre-FEL and FEL process Understand the importance of FEL, FEL stages; visualisation, conceptualisation, definition Uncover how to apply project management during FEL Determine risk management in the FEL process Understand benchmarking & value improving practices   Target Audience The course is recommended for anyone who wish to gain in-depth knowledge and understanding of the importance of Front-End Loading and how to apply Front End Loading best practices, including: Team Leaders Senior Managers (Line and Function) Project Managers Development Engineers Graduate Engineers Quality Assurance Engineers Key Contractor's Management FEED engineers Design engineers Mechanical engineers Process engineers   Course Level Basic or Foundation Trainer Your expert course leader is a subsea pipeline consultant with extensive experience in the design, construction, and installation of subsea pipelines for the oil and gas industry. As a consultant, he provides technical expertise and support to clients on all aspects of subsea pipeline projects, from the initial planning and design phase through to construction and commissioning. He is knowledgeable about industry standards, regulations, and best practices for subsea pipelines, and works closely with clients to ensure that projects are delivered safely, on time, and within budget. He has over thirty years' experience in early concept and front-end studies for the initiation of numerous high value upstream oil and gas projects worldwide. He has worked for both Operating Companies and Consultants managing the FEL process for complex, multi-discipline and technically challenging concepts, combining both his technical and project management skills. He has been working with companies like ExxonMobil, Quantum Power, North Caspian Operating Company, OMV Petrom, Port Meridian, BG Group, and etc.   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 Subsea pipelines play a critical role in the transportation of hydrocarbons (e.g. oil and gas) from offshore production sites to onshore facilities or other platforms. This course will cover design and construction of subsea pipelines with respect to: design for pressure containment, design for collapse, on-bottom stability, freespans, global (lateral and upheaval buckling), corrosion, materials selection, cathodic protection and coatings. Training Objectives Upon completion of this course, participants will be able to understand: Issues and challenges in subsea pipeline design Methods in applying pipeline design codes Techniques in how to specify a pipeline Key considerations in the main methods of pipeline construction Methods and issues surrounding pipeline intervention Target Audience The course is recommended for anyone who wish to gain in-depth knowledge and appreciation of the fundamental principles of the design and construction of subsea pipelines, including: Team Leaders Senior Managers (Line and Function) Project Managers Graduate Engineers Pipeline Engineers Senior Pipeline Engineers Subsea Engineers Integrity Engineers Quality Assurance Engineers Key Contractor's Management Course Level Basic or Foundation Trainer Your expert course leader is a subsea pipeline consultant with extensive experience in the design, construction, and installation of subsea pipelines for the oil and gas industry. As a consultant, he provides technical expertise and support to clients on all aspects of subsea pipeline projects, from the initial planning and design phase through to construction and commissioning. He is knowledgeable about industry standards, regulations, and best practices for subsea pipelines, and works closely with clients to ensure that projects are delivered safely, on time, and within budget. He has over thirty years' experience in early concept and front-end studies for the initiation of numerous high value upstream oil and gas projects worldwide. He has worked for both Operating Companies and Consultants managing the FEL process for complex, multi-discipline and technically challenging concepts, combining both his technical and project management skills. He has been working with companies like ExxonMobil, Quantum Power, North Caspian Operating Company, OMV Petrom, Port Meridian, BG Group, and etc. 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 Well engineers who are responsible for technically evaluating and authorizing programs for drilling or working over wells must have the required skills and competencies to safely design wells of varying nature. They also need to be able to confirm that well delivery and intervention programs generate intrinsic well control assurance. Such work programs must establish, verify, monitor and maintain suitable and sufficient barriers for the entire well lifecycle - from spud to abandonment. Well engineers must also be able to select a suitable drilling or workover rig, capable of safely performing the work within its operational envelope. This 3 full-day course aims to further develop and assess the knowledge required to work on and eventually, authorize a well delivery program as deemed fit for purpose. It also addresses elements of well control that must be embedded into well design, well work programming and equipment selection. This course is intended for participants who already have a sound understanding of the principles of the design and/or delivery of wells and with more than 3 years of relevant industry experience. Training Objectives By the end of this course, participants will be able to: Feel confident to design and plan drilling and workover activities while considering geological risks, formation pressures/strengths, and any integrity or well control concerns. Monitor wells operations and ensure that they can and will remain within the accepted design envelope. Assess risks and then apply mitigation or recovery methods in cases where design envelopes are threatened. Participants should be capable of assessing a drilling or workover program and then be able to answer the following key questions: Does the program delivery have a sound design and work plan that allows the well(s) to be drilled or worked over safely? Have we determined the appropriate kick tolerance for each open hole section and is it realistic for all drilling hazards that may be encountered? Have all drilling hazards been suitably assessed, and the associated risk mitigated to a level as low as reasonably practicable? Are there adequate, verifiable barriers in place throughout the operation and does everybody know their role and responsibility? And, as applicable, is the selected rig capable of implementing the work program? Target Audience This course is intended for personnel directly or indirectly involved in the preparation, review or authorization of drilling and workover programs. This includes: Well engineers and drilling supervisors who are responsible for planning and executing drilling and workover operations. Contractor well engineers, rig managers and other senior drilling staff. Senior well engineers and rig superintendents who are responsible for managing the delivery of a project or well. Technical authority holders who are responsible for licensing drilling and workover operations from a regulatory perspective. Assessment: A satisfactory command of critical knowledge and skills is assured by a 1+ hour closed book assessment. This assessment has a mix of multiple-choice questions (MCQs), calculations and answers that must be written up. The exam is taken electronically. Participants are provided with a suitable formula sheet. The pass mark for issuing a certificate is 70% and participants who are not successful will be issued with a certificate of attendance instead. Trainer Your expert course leader has over 45 years of experience in the Oil & Gas industry. During that time, he has worked exclusively in the well engineering domain. After being employed in 1974 by Shell, one of the major oil & gas producing operators, he worked as an apprentice on drilling rigs in the Netherlands. After a year, he was sent for his first international assignment to the Sultanate of Oman where he climbed up the career ladder from Assistant Driller, to Driller, to wellsite Petroleum Engineer and eventually on-site Drilling Supervisor, actively engaged in the drilling of development and exploration wells in almost every corner of this vast desert area. At that time, drilling techniques were fairly basic and safety was just a buzz word, but such a situation propels learning and the fruits of 'doing-the-basics' are still reaped today when standing in front of a class. After some seven years in the Middle East, a series of other international assignments followed in places like the United Kingdom, Indonesia, Turkey, Denmark, China, Malaysia, and Russia. Apart from on-site drilling supervisory jobs on various types of drilling rigs (such as helicopter rigs) and working environments (such as jungle and artic), he was also assigned to research, to projects and to the company's learning centre. In research, he was responsible for promoting directional drilling and surveying and advised on the first horizontal wells being drilled, in projects, he was responsible for a high pressure drilling campaign in Nigeria while in the learning centre, he looked after the development of new engineers joining the company after graduating from university. He was also involved in international well control certification and served as chairman for a period of three years. In the last years of his active career, he worked again in China as a staff development manager, a position he nurtured because he was able to pass on his knowledge to a vast number of new employees once again. After retiring in 2015, he has delivered well engineering related courses in Australia, Indonesia, Brunei, Malaysia, China, South Korea, Thailand, India, Dubai, Qatar, Kuwait, The Netherlands, and the United States. The training he provides includes well control to obtain certification in drilling and well intervention, extended reach drilling, high pressure-high temperature drilling, stuck pipe prevention and a number of other ad-hoc courses. He thoroughly enjoys training and is keen to continue taking classes as an instructor for some time to come. 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 Virtual Instructor Led Training (VILT)  A decision to drill an exploration well with the objective to find a new oil or gas field must be based on sound assessment of the prospect risk and of the volumes. What is the chance that a well will find hydrocarbons, and how much could it be? Risk and volume assessments form the basis for decisions to drill a well or not, and as such form the link between subsurface evaluation and the business aspects of the petroleum industry. This Virtual Instructor Led Training (VILT) course explains how risks and volumes can be assessed in a realistic manner, based on a sound understanding of the geological details of the prospect as well as its regional geological setting and current play understanding. Participants of this VILT course will receive a softcopy of Risk and Volume Assessment Handbook which explains the concepts that are associated with probabilistic Risk & Volume (R & V) Assessment and contains many practical recommendations on how to translate geological understanding into meaningful inputs for probabilistic R &V assessments. The book is fully compatible with any probabilistic R & V tool in the industry. Training Objectives By the end of this VILT course, participants will be able to understand: The fundamentals of risk and volumes assessment; translating geological understanding into reasonable numbers and ranges. The difference between risk and uncertainty. Fundamentals of statistics; including explanation of distribution curves, understanding of expectation curves, do's and don'ts for adding risked volumes, and Bayes theorem. Uncertainty of trap, reservoir, seal and charge, illustrated by examples. Guidelines and exercises for estimating risks realistically and consistently. Calculating volume ranges for prospects and for portfolios of prospects; how to add prospect volumes for a correct representation of prospect portfolios. Incorporation of geophysical evidence (DHIs) in a realistic risk assessment. Target Audience This VILT course has been designed in the first place for geoscientists working in exploration, for prospect portfolio analysts and for their direct supervisors. It will also benefit staff from disciplines working closely with exploration staff, such as reservoir engineers, petrophysicists and geophysicists. Course Level Intermediate Training Methods Learning, methods and tools The VILT course will be delivered online in 5 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. It is the intention to have at least 2 smaller exercises per day. Time will be reserved for recapitulation, questions and discussions. VILT will be conducted either via Zoom or Microsoft Teams. Presenting materials can easily be done on this platform. When participants need to ask a question, they can raise their hand, write notes or interrupt the Instructor by using their microphone. The presenter can switch to a screen where he/she can see all participants (also when each participant is sitting in another location e.g. at home). There is also a whiteboard functionality that can be used as one would use a flip chart. Exercises will be done on an online platform which provides each participant with a private work area that can be accessed by the Instructor to discuss the exercise in a similar manner as in a classroom course. Each topic is introduced by a lecture, and learning is re-enforced by practical exercises and discussions. Handout material in electronic format will be provided. Trainer Dr. Jan de Jager has a PhD in Geology from the University of Utrecht. He joined Shell in 1979 as an exploration geologist, and worked in several locations around the world such as Netherlands, Gabon, USA, Australia, Argentina, and Malaysia in technical and management positions. During the last 10 years of his career, he was responsible for the quality assurance of Shell's exploration prospects in many parts of the world and for upgrading and replenishing Shell's global exploration portfolio. During this period, he had also developed extensive expertise in Prospect Risk and Volume assessments for which he ran successful internal training programmes. Following his retirement from Shell in 2010, Dr Jan de Jager took on a position as part-time professor at the University of Amsterdam and also serves as a consultant exploration advisor for various E&P companies. 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

A virtual sales training programme aimed at enhancing the skills of the salesperson to have engaging customer conversations which open opportunities and close more business.

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

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