2 Educators providing Courses in Manchester

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 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 module aims to develop knowledge and understanding of the role of logistics including an understanding of air, sea, road and rail freight and courier services. It will explore the advantages and disadvantages of using the different modes of transport the world of international trade.

The Placement Course for Controllers in Oil & Gas and Construction aims to train Controllers who are able, through techniques of management control to achieve the objectives set in the most efficient way; with the ability to take immediate, corrective action during production. "Excellent training and know-how specific to Construction and Oil & Gas Sectors." This formula has been developed by Dirextra to offer new opportunities to future generations. Dirextra is the only provider to place highly qualified professionals within the Oil & Gas and Construction companies who sponsor our programme. Next editions: 📅 26 April 2024 ⏰ 37esima edition 📍 Manchester M4 1DZ (in presence) or live from remote Please send your application form to master@dirextra.com Brochure Placement Course Controllers in Italian Application Form  Brochure Dirextra in English Brochure Dirextra in Italian Why Manchester? Employment Opportunities The programme is delivered with the support of large Oil & Gas and Construction companies operating and producing on a contract basis all over the world who aim to hire young people as Company Controllers, Cost Controllers and Planners. 100% placement record for all previous cohorts with employment contracts in companies sponsoring the programme. PROGRAMME DETAILS 1200 hours over two terms: Term 1 (Classroom, personal study and thesis): 200 hours Term 2 (Work experience): 1000 hours During the six months of training on Construction and Oil & Gas sites accommodation and transfers will be provided by the host company. Our academic excellence, real world connections, global diversity and pivotal location give you outstanding advantages to kick-start your career. PROGRAMME TEACHERS The teaching is assigned to experts with years of experience in the construction and Oil & Gas industry (entrepreneurs, general managers.certified project managers, technical managers, site managers, human resources managers, lawyers, etc.) Programme Modules Construction Company Organization and Business Strategies Oil & Gas Company Organization and Business Strategies Administration, Control and Finance Legislation, Public Tendering Competitions Contract Management Drilling Engineering Advanced Project Management (with certificate) Planning Primavera P6 (with certificate) People Management Quality Management System Risk Management Procurement Management Managerial Accounting Cost Control (with certificate) Budgeting Construction Building Site Project Management Communication Management HSE Management Claims and Litigations Fidic and Standard Contract Form English for Construction Management Requirements, Procedures & Terms Applying Graduates in economics and management, may apply to be considered for this course. Please be aware that places are limited. Selection will be determined by qualifications and psychometric tests and interviews.  Submit applications via email to master@dirextra.com For more information please call us. Our Staff will call you back within 24 hours, if not available. United Kingdom phone number: office 00 44 (0) 161 795 6394‬ or mobile 0044 7765796588

Trauma Risk Management is an evidence based, peer delivered risk assessment and ongoing support system, designed specifically to help in the management of traumatic events.

The Placement Course for Professional Engineers in the Construction Infrastructure and Oil & Gas sectors aims to train engineers to become managers in Construction and Oil & Gas Companies who are able to manage business processes and construction site procedures.  The Placement Course for Professional Engineers Construction and Oil & Gas Sectors is accredited by CPD Certification Service in London. Accredited CPD training means the learning activity has reached the required Professional Development standards and levels. The learning value has been scrutinised to ensure integrity and quality. The CPD Certification Service provides recognised independent CPD accreditation compatible with global CPD requirements. The Course is delivered with the support of Multinational Companies operating worldwide.  Dirextra has more than 2,300 alumni engineers who have worked on the construction of major infrastructures around the world. There is no growth without engineers. Kick-start your career with a programme in Construction and Oil & Gas. Dirextra is a leader in the field of Construction Infrastructure, Oil & Gas and Engineering education. Next editions: 📅 26 April 2024⏰ 37esima edition📍 Manchester M4 1DZ (in presence) or live from remote Selection are now open please send your application form to master@dirextra.com Brochure Master Professional Engineers in Italian Brochure Master Professional Engineers in Spanish Brochure Master Professional Engineers in English Application Form Brochure Dirextra in English Brochure Dirextra in Italian Why Manchester? EMPLOYMENT OPPORTUNITIES The programme is supported by large Oil & Gas and Construction Infrastructure Companies operating all over the world aiming to hire young engineers. 100% successful placement in previous cohorts. DURATION AND TRAINING Total time: 1200 hours, of which 1000 are spent on work placement. - 2 months (200 hours) of training in the classroom, on personal study and the final thesis; - 6 months (1000 hours) of work on a Construction or Oil & Gas Site. Accommodation will be provided by the host company.  PROGRAMME MODULES Well delivered Training Course, complies with CPD criteria, Approved Construction Company Organisation and Strategies Oil & Gas Company Organisation and Strategies English for Construction Management Tendering International Procurement Project Management according to PMI Rules PM from Tender to Completion of works: A Real Case People Management Risk Management Planning Primavera P6 Cost Control Contract Management: from signing to testing Standard Contract Forms (FIDIC) and Claims Tunnelling and TBM (Tunnelling Boring Machine) Petroleum Engineering and Drilling (Wells and Rigs) QHSE of Construction Sites QHSE of Oil & Gas Sites PROGRAMME TEACHERS The teaching is assigned to experts with years of experience in the Construction and Oil & Gas industry coming directly from the sponsoring companies (entrepreneurs, general managers, project managers, technical managers, site managers, human resources managers, lawyers, etc.) REQUIREMENTS, PROCEDURES AND TERMS  Applying The Programme is aimed at graduates in Civil and Mechanical Engineering.However we will consider applications from all engineering graduates.Please be aware places are limited.Selection will be determined by qualifications. Fees and Financing Tuition fees £ 10,000. (pounds). Payment can be made in the following ways: in total at the time of registration (discount of £ 1,000 (pounds) in 4 instalments The Construction and Oil & Gas Companies sponsoring our Programme grant Scholarships to cover part of Tuition Fees. Scholarships are limited students who register in advance will receive a higher amount. Submit applications via email to master@dirextra.com For more information please call us. Our Staff will call you back within 24 hours, if not available. Office 0044 (0) 161 18808701 Mobile Eng. Carmen Andre' 0044 7765796588

Overview This Compliance and Risk Management Course is designed for anyone looking for a pathway into this profession and wanting to develop their industry knowledge and skills. It covers the role of the Compliance Officer and compliance department in detail, with step-by-step training in compliance auditing and risk management. This Compliance and Risk Management Training Course will equip you with the fundamental skills needed to identify and manage regulatory risk in your organization, taking you through key topics such as how to implement an efficient Compliance Management System, ethics and compliance, risk types and classifications, and how to design a solid risk management strategy. By the end of this Compliance and Risk Management Training Course, you'll have an excellent understanding of core compliance issues, as well as how to promote a positive compliance culture for your organization, which will give you a head start when it comes to standing out in the relevant job market. 

Overview This course is specially designed, this 5-day Financial Risk Management training course works to expand delegate's understanding and practical skills in the field of financial risk management. Specifically, this training course investigates the inter connection of risk in terms of markets, credit, operations, liquidity and reputation. Via intensive instruction and practical exercises, delegates will explore relevant techniques and methodologies, such as value-at-risk, credit modelling and stress testing.

Overview With the change in the density of enterprise risk, new risks have emerged, and managing it has become everyone's responsibility. The new Enterprise Risk Management course offers you the exclusive opportunity to learn the concepts and principles of the newly updated ERM framework and to integrate the framework into your organisation's strategy. The course is designed with all the modules to provide you with the knowledge necessary to understand and apply Enterprise Risk Management - Integrating with Strategy and Performance. The ERM framework assists management and boards of directors with their respective duties for managing risk.

About this Training Course The two elements which consistently remain in the forefront of every executive, tasked to manage a project, are 'Cost' and 'Time'. There is probably no disagreement or a need to prove that a strong correlation exists between Cost and Schedule. The mechanics of capturing cost during the execution is not that difficult a task, as it is when undertaking Design, Engineering, Estimating, Planning, Scheduling, and seeking financing for the project. The corporate management is expected to provide realistic, reliable and risks adjusted projections of a project's overall financial performance. This 3 full-day course and workshop is developed to make the delegates walk through the engineering formulas and equations to become a professional in managing estimates, projections, risks, uncertainties and secure financing for high value, high risk projects, from both On-shore and Offshore Oil & Gas industry segments. This course can also be offered through Virtual Instructor Led Training (VILT) format. Training Objectives Objectives of this Training Course: This course and the workshops are developed for the participants to gain comprehensive understanding of the field of Cost Engineering and its impact on the project execution, financing and risk management. The underlying objectives are: Enhance familiarization with mechanics of cost engineering in developing budgets and Project Cost Models. Gain understanding of diversity in financing of EPC Projects in context of Offshore and Onshore Oil & Gas projects in international arena. Identify risks associated with cost estimates and costing elements, with an objective of developing project strategies and minimizing the exposure to escalation of prices and market factors. Appreciate the correlation between cost and schedule, resulting in the delivery of contractual obligations. Develop competency to manage risks of costs and time overrun, by implementing appropriate cost control mechanism. Target Audience If you are responsible for undertaking one or more of the following functions in the Oil & Gas and Offshore & Marine Industry, you can't afford to miss this course: Management Accountants, Finance Managers, Cost Controllers, Project Directors, Contracts & Projects Managers, Estimators, Planners and Risk Managers. Course Level Intermediate Training Methods Unique Features of this Enhanced Course Curriculum: This course and the workshops are developed for the participants to gain comprehensive understanding of the field of Cost Engineering and its impact on the project execution, financing and risk management. The underlying objectives are: Enhance familiarization with mechanics of cost engineering in developing budgets and Project Cost Models. Gain understanding of diversity in financing of EPC Projects in context of Offshore and Onshore Oil & Gas projects in international arena. Identify risks associated with cost estimates and costing elements, with an objective of developing project strategies and minimizing the exposure to escalation of prices and market factors. Appreciate the correlation between cost and schedule, resulting in the delivery of contractual obligations. Develop competency to manage risks of costs and time overrun, by implementing appropriate cost control mechanism. Trainer Principal Management Consultant Chartered Valuer and Appraiser (CVA) FACICA | FAMTAC | FAIADR | M.S.I.D | Member, AIEN LL.M. (IP Law), M. Sc. (Maritime Studies), M. Tech (Knowledge Engineering), MBA, First Class CoC (MCA, UK), B. E. (Elect) Your expert course leader, during the last 47 year period, has worked and consulted in the industry verticals encompassing: Technology, Oil & Gas Exploration & Production, Petrochemical Process Plants and Power Plant Construction Projects, Logistics & Warehousing, Marine, Offshore, Oil & Gas Pipelines, Infrastructure Development Projects (Ports, Offshore Supply Bases, Oil & Gas Terminals and Airports etc), EPCIC Contracts, and Shipyards, in South East Asia, Africa, Middle East, Americas and Europe. He serves as the Principal Management Consultant with a management consultancy in Hong Kong and Singapore, specialising in the fields of corporate management consultancy, international contracts reviews and alternative dispute resolutions services. He undertakes special assignments for conducting audits and valuation of intangible properties involving proprietary processes for licensed production, and licensing of intellectual property rights (IP Rights) in patents, trademarks, and industrial designs. He is frequently engaged for assignments like due diligence, acquisitions, mergers, resolving various operational issues, technology transfer and agency services contracts reviews, cost controls, and enhancement of Supply Chain Management. He has been conferred the credentials of Chartered Valuer & Appraiser (CVA) by SAC and IVAS, in accordance with the international valuation standards setting body IVSC. His consulting experience includes Charterparty Management, Business Process Re-engineering, Diversifications, Corporate Development, Marketing, Complex Project Management, Feasibility Studies, Dispute Resolutions and Market Research. He has successfully assisted Marine and offshore E & P clients in managing contractual disputes arising from various international contracts for upgrading & conversion projects. He continues to be actively engaged in claims reviews, mediation, arbitration, litigation, and expert witness related assignments, arising from international contracts and Charterparty Agreements. He graduated with a Bachelor's degree in Electrical Engineering, MBA in General Management, Master of Technology in Knowledge Engineering, Master of Science in Maritime Studies, and LL.M. (IP Law). He also holds professional qualifications in Business Valuations and Appraisers for CVA, arbitration, law, and marine engineering, including the Chief Engineer's First-Class Certificate of Competency (MCA, UK). He is further qualified and accredited as Certified International Arbitrator, Chartered Arbitrator, Sports arbitrator under CAS Rules, WIPO Neutral, Australian Communications and Media Authority (ACMA) Bargaining Code Arbitrator, Accredited Adjudicator and Accredited Mediator (Malaysia). He is admitted to the international panels of arbitrators and neutrals with WIPO, Geneva; ACICA, AMTAC and ACMA, Australia; BVIAC (British Virgin Islands); JIAC (Jamaica); HKIAC Hong Kong; AIAC, Malaysia; AIADR, Malaysia; KCAB, Seoul, South Korea; ICA, Delhi, India; ICC (Singapore); SISV, Singapore; SCMA, Singapore; SCCA, Saudi Arabia; VIAC Vienna, Austria; Thailand Arbitration Centre (THAC), and Mediator with AIAC Malaysia, CMC, and SIMI Singapore. 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