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DGSA training

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face 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 23 Points   Development Level Develop

About this training Mature fields differ from green field developments in that major infrastructure is in place, static reservoir data has accumulated from development drilling and a growing volume of production and processing performance data has become available. Decisions therefore relate to incremental projects, which may be small in scope and are often economically marginal. A firm understanding of the technical fundamentals associated with reservoir, wells and surface facilities is therefore required to make quality decisions in this environment, supported by realistic uncertainty ranges, and consistent application of incremental project economics and risk analysis. Various strategies may be considered to manage the mature asset, from harvest to divest, and the selected incremental activities should support a clear chosen strategy. Training Objectives Upon completion of this course, participants will be able to: Characterize the overall challenges associated with mature field developments Evaluate critical insights from subsurface data and apply this to modelling options and recovery methods Assess associated well data, typical late life issues and drilling and completion options for mature developments Manage the role of risk and uncertainty when making mature field development planning decisions Prepare a strategy and implementation plan Target Audience The course is intended for individuals who play a part in evaluating, screening and maturing oil and gas field development opportunities. The following personnel will benefit from the knowledge shared in this course: Petroleum engineers Geoscientist Facilities engineers Commercial staffs Reservoir engineer Production engineer Drilling engineer Project manager Asset manager Field engineer Exploration manager Course Level Basic or Foundation Trainer Your expert course leader, boasts nearly four decades of experience in the upstream oil & gas industry. He began his career in the back in 1982, spending 13 years with Shell International across several global locations. During his tenure, he served primarily as a reservoir engineer, contributing to exploration prospect evaluation, field development planning, corporate business planning, and drilling operations. Throughout his career, he has executed a diverse range of reservoir engineering projects for multiple UK and international firms, and has successfully led several PE study teams. Furthermore, he has continuously provided reservoir engineering and commercial training to oil company staff on a national and international scale. 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

Duration 5 Days 30 CPD hours This course is intended for This course is designed for IT professionals who want to develop penetration testing skills to enable them to identify information-system vulnerabilities and effective remediation techniques for those vulnerabilities. Target students who also need to offer practical recommendations for action to properly protect information systems and their contents will derive those skills from this course. This course is also designed for individuals who are preparing to take the CompTIA PenTest+ certification exam PT0-002, or who plan to use PenTest+ as the foundation for more advanced security certifications or career roles. Individuals seeking this certification should have three to four years of hands-on experience performing penetration tests, vulnerability assessments, and vulnerability management. Overview After completing this course, you will be able to plan, conduct, analyze, and report on penetration tests, including the ability to: Plan and scope penetration tests. Conduct passive reconnaissance. Perform non-technical tests to gather information. Conductive active reconnaissance. Analyze vulnerabilities. Penetrate networks. Exploit host-based vulnerabilities. Test applications. Complete post-exploit tasks. Analyze and report pen test results. Security remains one of the hottest topics in IT and other industries. It seems that each week brings news of some new breach of privacy or security. As organizations scramble to protect themselves and their customers, the ability to conduct penetration testing is an emerging skill set that is becoming ever more valuable to the organizations seeking protection, and ever more lucrative for those who possess these skills. In this course, you will be introduced to some general concepts and methodologies related to pen testing, and you will work your way through a simulated pen test for a fictitious company. 1 - Outline Lesson 1: Scoping Organization/Customer Requirements Lesson 2: Defining the Rules of Engagement Lesson 3: Footprinting and Gathering Intelligence Lesson 4: Evaluating Human and Physical Vulnerabilities Lesson 5: Preparing the Vulnerability Scan Lesson 6: Scanning Logical Vulnerabilities Lesson 7: Analyzing Scanning Results Lesson 8: Avoiding Detection and Covering Tracks Lesson 9: Exploiting the LAN and Cloud Lesson 10: Testing Wireless Networks Lesson 11: Targeting Mobile Devices Lesson 12: Attacking Specialized Systems Lesson 13: Web Application-Based Attacks Lesson 14: Performing System Hacking Lesson 15: Scripting and Software Development Lesson 16: Leveraging the Attack: Pivot and Penetrate Lesson 17: Communicating During the PenTesting Process Lesson 18: Summarizing Report Components Lesson 19: Recommending Remediation Lesson 20: Performing Post-Report Delivery Activities Additional course details: Nexus Humans CompTIA Penetration Testing Certification (PenTest Plus) - (Exam PT0-002) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the CompTIA Penetration Testing Certification (PenTest Plus) - (Exam PT0-002) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Ideal for those wanting a completely practical Hair Cutting and Colouring Course. You’ll learn the 9 Alan d foundation haircuts along with finishing techniques, shampooing, cutting, styling, blow-drying, client care and salon protocol. After 4 weeks (20 days), you will then move on to a 4 week (20 days) colour class covering basic product knowledge, root coverage, full-head colour, foils, meche & Balayage. You will be taught on both dummy heads & live models.

Duration 5 Days 30 CPD hours This course is intended for This course is intended for novice database developers, database administrators, Business Intelligence developers, report creators, and application developers who have an understanding of relational database concepts and have basic Windows navigation skills. Overview Create single table SELECT queries Create multiple table SELECT queries Filter and sort data Insert, update, and delete data Query data using built-in functions Create queries that aggregate data Create subqueries Create queries that use table expressions Use UNION, INTERSECT, and EXCEPT on multiple sets of data Implement window functions in queries Use PIVOT and GROUPING SETS in queries Use stored procedures in queries Add error handling to queries Use transactions in queries This five-day instructor-led course is intended for IT professionals who wish to use the Transact-SQL language to query and configure Microsoft SQL Server. Students are typically database developers and database administrators, but might also be Business Intelligence developers, report creators, or application developers. In this course, students learn how to query single tables, join data from multiple tables, filter and sort data, modify data, use procedures and functions, and implement error handling. Prerequisites Basic understanding of relational databases. Basic Windows knowledge. Module 1: Introduction to Transact-SQL What is Transact-SQL The SELECT statement The WHERE clause Sorting results Calculations CASE expressions Module 2: Joining tables with Transact-SQL The JOIN clause Inner joins Outer joins Self joins and cross joins Module 3: Filtering and sorting results Implement the ORDER BY clause Filter data with the WHERE clause Limit the number of rows returned by a query Implement NULL logic Module 4: SQL Server data types Understand data types Implement string data types Implement temporal data types Module 5: Inserting, updating and deleting data Insert new records Update existing records Delete data Module 6: Using SQL Server functions with Transact-SQL Understand function types in SQL Server Convert data using functions Implement logical functions Work with NULL data using functions Module 7: Aggregating data with Transact-SQL Implement aggregation in SQL Server Group records in SQL Server Filter aggregated data Module 8: Implement subqueries with Transact-SQL Implement scalar and multi-valued sub-queries Implement correlated subqueries Implement existence checks with subqueries Module 9: Create queries that use table expressions Create views Create table-valued functions Implement derived tables Implement common table expressions Module 10: Use UNION, INTERSECT, EXCEPT and APPLY on multiple sets of data Write queries with the UNION operator Write queries with the INTERSECT and EXCEPT operators Write queries with the APPLY operator Module 11: Implement window functions in queries Understand window functions Impement window functions Module 12: Use PIVOT and grouping sets in queries Implement PIVOT in queries Implement grouping sets in queries Module 13: Use stored procedures in queries Query data with stored procedures Interact with stored procedures using input and output parameters Write simple stored procedures Pass dynamic SQL to SQL Server Module 14: Implement programming features in Transact-SQL Understand T-SQL programming elements Implement loops and conditions in T-SQL queries Module 15: Add error handling to queries Understand SQL Server error handling Implemet structured exception handling Module 16: Use transactions in queries Understand database transactions Implement transactions in T-SQL

This Beginners Barbering Course is aimed at those looking to be work-ready upon completion and working towards an internationally recognised Barbering qualification. After an initial induction, on day 2 you will learn to cut & style utilising the 5 Alan d Foundation haircuts before moving on to the practical elements of Barbering, incorporating all the latest techniques using scissors, scissor-over-comb, clippers & trimmers and learning beard and moustache trimming and wet shaving.

Experience safer urban roads with our FORS Approved Virtual Reality Safe Urban Driving Training. Our immersive program empowers drivers to navigate bustling city streets alongside vulnerable road users, fostering a culture of road safety. With a seven-hour DCPC-approved course, participants gain valuable insights and skills for responsible driving. Invest in your drivers' safety and meet compliance requirements while protecting lives on the road. Elevate road safety with our innovative VR training. Learn more at www.totalcompliance.co.uk

Disciplined Agile Value Stream Consultant (DAVSC) Training Workshop The Disciplined Agile Value Stream Consultant workshop teaches you how to use value stream management to create a tailored approach for any organization to accelerate delivery of value to their customers. It provides a combination of Lean, Flow, Theory of Constraints and Organizational Development theories and practices. The workshop integrates with the Disciplined Agile tool kit to provide those practices that will be most effective for where it is applied, whether it be a new Agile transition or continuing a stagnated SAFe® or Spotify one. What You Will Learn After the completion of this course, you will be able to: Learn to determine the best place for an organization to start - portfolio management, product management or development area Be equipped to tailor an organization's improvement plan based on their unique needs, while also attending to the culture of the organization to evolve at their proper pace Be able to train an organization to continue to improve on their own Know how to accelerate value delivery at scale Be prepared to take the Disciplined Agile Value Stream Consultant (DAVSC) exam and earn valuable, credible certification. Your exam fee is included in tuition. The course is comprised of an introduction and 14 lessons and supplemental materials provided electronically: Introduction: The Disciplined Agile Mindset Lesson 1: Value Stream Consultant: Role and Work Lesson 2: The Idealized Value Stream Lesson 3: Removing Delays in the Workflow Lesson 4: The Minimum Business Increment Lesson 5: The Discovery Workflow and the Development Intake Process Lesson 6: Value Flow Planning and Coordination Lesson 7: Working with a Common Cadence and Synchronization Lesson 8: End of Increment Activities and Reducing, Not Accommodating Dependencies Lesson 9: Factors for Effective Value Streams Lesson 10: Value Creation Structure Lesson 11: Agile Budgeting and Lean Funding Lesson 12: Creating Visibility Across the Organization Lesson 13: Key Roles Lesson 14: The Disciplined Agile Playbook

Duration 5 Days 30 CPD hours This course is intended for This course is intended for professional web developers who use Microsoft Visual Studio in an individual-based or team-based, small-sized to large development environment. Candidates for this course are interested in developing advanced web applications and want to manage the rendered HTML comprehensively. They want to create websites that separate the user interface, data access, and application logic. Overview Describe the Microsoft Web Technologies stack and select an appropriate technology to use to develop any given application. Design the architecture and implementation of a web application that will meet a set of functional requirements, user interface requirements, and address business models. Configure the pipeline of ASP.NET Core web applications using middleware, and leverage dependency injection across applications. Develop a web application that uses the ASP.NET Core routing engine to present friendly URLs and a logical navigation hierarchy to users. Create Views in an application that display and edit data and interact with Models and Controllers. Connect an ASP.NET Core application to a database using Entity Framework Core. Implement a consistent look and feel across an entire web application. Write JavaScript code that runs on the client-side and utilizes the jQuery script library to optimize the responsiveness of an web application. Add client side packages and configure Task Runners. Run unit tests and debugging tools against a web application in Visual Studio 2022. Write an application that authenticates and authorizes users to access content securely using Identity. Build an application that resists malicious attacks. Use caching to accelerate responses to user requests. Use SignalR to enable two-way communication between client and server. Describe what a Web API is and why developers might add a Web API to an application. Describe how to package and deploy an ASP.NET Core web application from a development computer to a web server. In this 5-day course, professional web developers will learn to develop advanced ASP.NET Core applications using .NET tools and technologies. The focus will be on coding activities that enhance the performance and scalability of the Web site application. Module 1: Exploring ASP.NET Core Introducing of Microsoft Web Technologies Getting Started with Razor Pages in ASP.NET Core Introducing ASP.NET Core MVC Module 2: Designing ASP.NET Core MVC Web Applications Planning in the Project Design Phase Designing Models, Controllers and Views Module 3: Configure Middleware and Services in ASP.NET Core Configuring Middlewares Configuring Services Module 4: Developing Controllers Writing Controllers and Actions Configuring Routes Writing Action Filters Module 5: Developing Views Creating Views with Razor Syntax Using HTML Helpers and Tag Helpers Reusing Code in Views Module 6: Developing Models Creating MVC Models Working with Forms Validating User Input Module 7: Using Entity Framework Core in ASP.NET Core Introduction to Entity Framework Core Working with Entity Framework Core Use Entity Framework Core to connect to Microsoft SQL Server Module 8: Using Layouts, CSS and JavaScript in ASP.NET Core Using Layouts Using CSS and JavaScript Using JavaScript Libraries Module 9: Client-Side Development Applying Styles and Responsive Design Using Task Runners Looking at ASP.NET Core Blazor Module 10: Testing and Troubleshooting Testing ASP.NET Core Applications Implementing an Exception Handling Strategy Logging ASP.NET Core Applications Module 11: Managing Security Authentication in ASP.NET Core Authorization in ASP.NET Core Defending from Common Attack Module 12: Performance and Communication Implementing a Caching Strategy Managing State Supporting Two-way Communication Module 13: Implementing Web APIs Introducing Web APIs Developing a Web API Calling a Web API Module 14: Hosting and Deployment Hosting and Deploying On-premises Deploying to Microsoft Azure Looking at Microsoft Azure Fundamentals