2471 Courses in Huntingdon

Lawful Intercept training course description Packet based networks require a different approach to Lawful Intercept (LI) than that used in circuit switched networks. This course focuses on what Lawful Interception and Data Retention (DR) means to communications service providers in the IP and NGN areas. The course assumes a basic knowledge of IP networking (i.e. DNS, TCP/UDP, IP, RTP) and the building of services on an IP platform (e.g. SIP, SDP, FTP, HTTP). The course first looks at the regulatory context for LI and DR and how this is translated to a practical architecture. What will you learn Recognise the legal and regulatory obligations to provide LI and DR. Identify the components of the handover architecture for each of LI and DR. Identify the preferred location of points of interception and points of retention in the IP network. Map intercepted material to handover protocols. Understand the data mapping defined in the available standards for both LI and DR. Lawful Intercept training course details Who will benefit: Technical and managerial staff needing to implement public networks. Prerequisites: TCP/IP Foundation Duration 1 day Lawful Intercept training course contents What is meant by LI and DR? Review of regulation: Data protection Directive; Data Retention Directive; RIPA. LI architectures Handover and Interception: ETSI standards ES 201 671 and TS 102 232. LI handover protocol IRI and CC handover; correlation; manual interfaces. DR architectures Handover of query results; points of retention. DR query command set Retrieval of retained records. Security concerns Operation privacy; target privacy; storage and transmission integrity. Implementation Identifying PoI and PoR for provided services. LI and DR wrap up Interaction with other services, storage obligations (volume, time, availability).

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

About this Training Course To the non-geologist, working with Petroleum Geologists can be confusing. Petroleum geology has specific terminology and many concepts and data sources unfamiliar to the uninitiated. This course has been designed to introduce these terms and provide an insight into how oil and gas are formed, how they are found and how they are extracted. Using a holistic combination of lectures, experiments, case study and practical exercises, the course involves an introduction to fundamental geological concepts, to exploration techniques, prospecting, drilling, well logs and recovery methods. The course will also demystify the terminology surrounding petroleum geology, demonstrate the use of geological information to show the value and weakness of different datasets, and lead to better communication and decision-making between the geologists and non-geologists. It will feature world-class virtual reality field trips that incorporate activities and features unavailable in the physical field, and provide for a more integrated and flexible learning resource (also see the trainer's article on page 4 which was first published in GEO ExPro Magazine, the upstream oil and gas industry's favourite magazine). Course Highlights: Course facilitator has delivered petroleum geology training to many companies over the years Facilitator is also a professionally trained teacher and former university lecturer who is experienced in communicating with people at all levels of technical knowledge Practical exercises, experiments, examination of real rocks, a virtual reality field trip and case study are used to clarify and reinforce important concepts Training Objectives By attending this training, you will be able to acquire the following: Understand the geological methods and principles used in hydrocarbon exploration, development and production. Understand the key elements of a petroleum system, from hydrocarbon source to reservoir and seal Appreciate basin analysis, regional geology and play based exploration techniques Be aware of the different sorts of hydrocarbon trap from structural to stratigraphic Understand the technical terminology, tools and methods used in exploration geology Learn about unconventional Understand and evaluate the sources and reliability of various types of geological information Understand acquisition, processing and interpretation of seismic data Learn the technical processes and terminology involved in exploration Understand how a prospect is defined and risked Understand how seismic, existing well information and outcrop geology can be used for exploration Gain an understanding of the methods used for petroleum geology to allow a discovery to be appraised and then developed Target Audience The course is suitable to all personnel, but those that benefit most include: This course will benefit Petroleum Engineers (reservoir, drilling, production) who work with geological data, Geophysicists with little or no geological background, Project managers whose teams include petroleum geologists, Finance, Procurement, Marketing and Communications staff, and government Data Managers who handle petroleum geological data and need to understand the sources of different types of data. Trainer Your expert course leader is the Geosciences Technical Director for PetroEdge. She was previously, the manager of Robertson Petroleum Training Centre and a Senior Project Scientist at Robertson CGG. She has over 20 years of experience in teaching geology and leading field trips. Prior to her 8 years at Robertson, she was in academia as a lecturer for 6 years and a Research Fellow for 3 years. She has conducted fieldwork and led field trips in the US and many areas in the UK. In addition, she has led university regional geology day schools and has comprehensive experience in course and study programme writing. She has extensive experience in delivering courses and in Clastic and Carbonate Reservoir Geology, Deepwater Turbidites, Sandstone Reservoirs, Wireline Log Interpretation, Integrated Sequence Stratigraphy, Basin Analysis and Exploration & Appraisal workshops globally. In delivering the Exploration Team Management Workshop, she has project managed and taught key principles and modules on project planning, data collection/collation, geophysical assessment, stratigraphy and facies mapping, source rock facies and hydrocarbon generation, play fairway mapping, risking and prospect evaluation. Her knowledge and enthusiasm for instructing is reflected in consistently being rated as excellent by trainees, and clients specifically requesting her participation in courses. 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 Within the energy industry, it is a requirement, both contractual and in some areas legislative, to ensure effective internal systems are in place which support employee development and provide evidence of their competence. A Competence Management and Assurance process - if correctly developed and applied - provides employees and organisations with the tools to demonstrate competence and contributes to career development of the individual. The 3 full-day course focuses on Competence Management Systems (CMS) which are typically in use within the Energy Industry, their structure and process development requirements. In addition, the course details the assessment process, the role of the competency assessors within the organisation and the relationship between competence management and training provision. For impactful learning, the course instructor uses a variety of instructional methodologies such as lectures, discussions, individual reflection, games, mystery puzzles, video, case studies, team syndication, group presentations, sharing and feedback. Training Objectives This course will provide attendees with an understanding of: The role of competencies in the Energy industry The benefits of Competency Management System to the organisation The components of a Competency of Competency Management System The know how to implement the Competency Management System The roles and responsibilities within a Competency Management System The know how to develop Competency Models The relationship between Competency Management and Capability Development The know how to conduct Organisational Analysis The know how to conduct Job Analysis and Task Analysis The know how to develop Competency Standards and Development Guides using the 70:20:10 principle The competency assessment process, tools and methodologies The know how to package and communicate the Competency Assessment Reports to Management Competency Management Case Studies in the Energy Industry Target Audience This course will benefit professionals from Human Resource and Capability Development as well as Line Managers. Course Level Basic or Foundation Trainer Your expert course leader is an independent consultant trainer with more than 30 years of experience in People & Organizational Development. She has retired from her full-time job and is currently serving as an Associate Consultant / Trainer with several Learning & Development organizations operating in Malaysia and Singapore. A chemist by training, her interest in People & Organizational Development was so intense that she decided to switch profession during her earlier years of employment, and she has never looked back since. She has gathered extensive hands-on experience, leading key projects and delivering learning programs in her field of expertise with numerous leading organizations in South East Asia, the Middle East and Europe. A project that she is particularly proud in completing was the transformation of PETRONAS Management Training Institute into a regional Leadership Centre. While leading this project, she was given the opportunity to be seconded to General Electric (GE), a Fortune 500 multinational known for its cutting-edge leadership development innovation. She was instrumental in the development of the existing leadership model for PETRONAS. In addition, she was also extensively involved in the development and implementation of Technical Competency Development process that is currently being used by more than 20 disciplines in the organization. Another massive project that she was heavily involved in was the creation of the quality culture for PETRONAS. The project saw the establishment of PETRONAS' own quality principles where she played a key role in propagating the desired mindset towards the creation of a high performing culture. Her involvement in this project took her to many PETRONAS Operating Companies which spanned into several countries across the globe including Malaysia, Indonesia, Vietnam, Sudan, South Africa and Switzerland, creating awareness through learning programs and consultancy services. The PETRONAS Quality Principles have since evolved into shared values that are now known as the PETRONAS Culture Beliefs. In keeping her expertise current after retiring from full-time employment since 2017, she has continued to deliver learning programs, providing coaching and consultancy services to selected Oil & Gas companies in Malaysia, Indonesia, Singapore, India, Oman and Thailand. Among her most recent work are virtual learning deliveries and consultancies during the COVID-19 pandemic to some government linked companies / agencies in Malaysia and PTT Exploration & Production Company of Thailand. Outside her professional circle, she is an avid cyclist, a jungle tracker and a mount climber. She is also an accredited trainer from the Human Resource Development Corporation (HRD CORP). 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 A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 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 14 Points Development Level Learn

Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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 14 Points Development Level Develop

Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 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 14 Points Development Level Develop

DASA DevOps Fundamentals: In-House Training The DASA DevOps Fundamentals™ certification provides the core education necessary to build your DevOps vocabulary and understand its principles and practices. It's the ideal starting point for DevOps journeys, whether you're already familiar with working with Agile and/or DevOps teams or not. Faster software deployment, increased deployment frequency, and higher change success rate are only some of the visible outcomes of practicing DevOps. Organizations such as Netflix, Spotify, and Facebook are transforming IT by successfully implementing DevOps principles. But you don't have to be big to be a DevOps leader. Companies large and small, young and old, have smoothly made the transition and have the proof of success in their pockets. This course will inspire you to serve as a change champion by sharing and using what you learned, and continue to learn, about DevOps to lead and mentor others. A solid understanding of DevOps Fundamentals has helped numerous professionals and organizations how to approach a DevOps journey, not only from a tool and automation perspective but also looking in-depth at the softer side of things. This course provides learners with an extensive introduction to the core Agile DevOps principles. It covers all 12 key knowledge and skill competencies defined by DASA to ensure you acquire a solid knowledge of DevOps concepts and terminology. Multiple cases or scenarios, group discussions, and examples are included in the course to enhance your learning experience. What you will Learn DASA DevOps Fundamentals-certified professionals are able to: Explain the drivers responsible for the emergence of DevOps. Define and discuss the key concepts and principles of DevOps. List and explain the business benefits of DevOps and continuous delivery. Know how teams can translate DevOps principles into tangible practices. Learn about modern operations in a DevOps context. Explain the concepts of test automation, infrastructure automation, and build and deployment automation. Describe how DevOps relates to Lean and Agile methodologies. Get insight into the various organizational DevOps models and architectures. Identify how Cloud and Delivery pipeline automation optimizes and accelerates the ways of working. Discuss the critical success factors for DevOps transformation. Introducing DASA DevOps Fundamentals DASA DevOps Fundamentals An Introduction Case Study - Easy Journey Airways Building the DevOps Context DevOps Evolution Business Benefits of DevOps DASA DevOps Principles Goals and Measurements Knowing DevOps for Individuals T-Shape Profiles DevOps Capabilities by DASA DASA DevOps Certifications Getting Acquainted with DevOps Culture and Behavior Embracing a DevOps Culture Core Elements of a DevOps Culture Implementation of a DevOps Culture Understanding the Value of DevOps for Teams and Organizations Organizational Models Team Autonomy DevOps at Scale Getting Familiar with DevOps Management Practices ITSM Lean Agile Getting Familiar with DevOps Technical Practices Architecture Modern Infrastructure and Cloud Operations Enabling DevOps Team Performance Through Continuous Delivery and Automation Software Delivery Automation Concepts Continuous Delivery Core Concepts Continuous Delivery Automation Concepts Continuous Delivery Automation Focus Topics Measuring the Performance - The Next Steps Analyze the Current Situation Improve Incrementally

SAFe® DevOps: In-House Training This course provides a comprehensive overview for understanding the DevOps skills needed to accelerate time-to-market by improving the flow of value through the Continuous Delivery Pipeline. You will map the current value stream through the delivery pipeline from idea to cash and identify practices that will eliminate bottlenecks to flow. The course will build an understanding of the complete flow of value from Continuous Exploration to Continuous Integration, Continuous Deployment, and Release on Demand. What you will Learn After attending the class, attendees should be able to: Explain how DevOps enables strategic business objectives Apply a CALMR approach to DevOps to avoid automating broken processes Understand how successful DevOps requires continuous exploration, continuous integration, continuous deployment, and the ability to release to end users on demand Incorporate continuous testing and continuous security into the delivery pipeline Use value-stream mapping to measure flow and identify bottlenecks in the end-to-end delivery process Select DevOps skills and tools strategically for the fastest, most compelling results Prioritize DevOps solutions and investments for the greatest economic benefit Design and implement a multi-phased DevOps transformation plan tailored to their organization Work with all roles and levels in the organization to continually optimize the value stream Introducing DevOps Mapping your Continuous Delivery Pipeline Gaining alignment with Continuous Exploration Building quality with Continuous Integration Reducing time-to-market with Continuous Deployment Delivering Business Value with Release on Demand Taking action

SAFe® Scrum Master: In-House Training Build your skills as a high-performing team member of an Agile Release Train (ART) and prepare to support the facilitation of team and program events when you become a SAFe® 5 Scrum Master (SSM). In this course, you'll gain an understanding of the role of Scrum Master in a SAFe® enterprise. Unlike traditional Scrum Master training that focuses on the fundamentals of team-level Scrum, the SAFe® Scrum Master course explores the role of the Scrum Master in the context of the entire enterprise and prepares you to successfully plan and execute the Program Increment (PI), the primary enabler of alignment throughout all levels of a SAFe® organization. What you will Learn To perform the role of a SAFe® Scrum Master, attendees should be able to: Describe Scrum in a SAFe® enterprise Facilitate Scrum events Facilitate effective Iteration execution Support effective Program Increment execution Support relentless improvement Coach Agile teams for maximum business results Support DevOps implementation Build a high-performing ART by becoming a servant leader and coach Develop an action plan to continue your learning journey Introducing Scrum in SAFe® Characterizing the role of the Scrum Master Experiencing Program Increment planning Facilitating Iteration execution Finishing the Program Increment Coaching the Agile team