63496 Courses

SAFe® for Teams Build the skills needed to become a high-performing team member of an Agile Release Train (ART) and learn how to collaborate effectively with other teams by becoming a SAFe® 5 Practitioner (SP). During this course, you will gain an in-depth understanding of the ART, how it delivers value, and what you can do to effectively perform the role using Scrum, Kanban, and Extreme Programming (XP). You will also learn how to write stories and break down features, plan and execute iterations, and plan Program Increments. Finally, you'll learn about the continuous delivery pipeline and DevOps culture, how to effectively integrate with other teams in the program, and what it takes to continuously improve the train. What you will Learn To perform the role of a SAFe® Practitioner, you should be able to: Apply SAFe® to scale Lean and Agile development in their enterprise Know their team and its role on the Agile Release Train Know all other teams on the train, their roles, and the dependencies between the teams Plan Iterations Execute Iterations and demonstrate value Plan Program Increments Integrate and work with other teams on the train Introducing the Scaled Agile Framework® (SAFe®) Building an Agile Team Planning the Iteration Executing the Iteration Executing the Program Increment Practicing SAFe®

SAFe® Scrum Master 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

SAFe® for Government Transitioning to Lean-Agile practices for building technology-based capabilities is especially challenging in the government context. But issues of legacy governance, contracting, and organizational barriers can be overcome with the right information and strategies. During this course, attendees will learn the principles and practices of the Scaled Agile Framework® (SAFe®), how to execute and release value through Agile Release Trains, and what it means to lead a Lean-Agile transformation of a program inside a government agency. Attendees gain an understanding of the Lean-Agile mindset and why it's an essential foundation for transformation. They'll also get practical advice on building high-performing, multi-vendor Agile teams and programs, managing technology investments in Lean flow, acquiring solutions with Agile contracting, launching the program, and planning and delivering value using SAFe®. Attendees also learn how specific leadership behaviors can drive successful organizational change in government. What you will Learn To perform the role of a SAFe® for Government leader, you should be able to: Transition government programs from traditional software and systems development models to Lean-Agile and DevOps mindsets, principles, and practices using SAFe® Adapt technology strategy, budgeting and forecasting, acquisition, compliance, and governance processes to flow-based practices using emerging government guidelines Organize government programs into one or more Agile Release Trains (ARTs) and execute in Program Increments (PIs) Explore Large Solution coordination in a government and multi-vendor environment Identify and internalize the mindset and leader behaviors essential to successful Lean-Agile transformation Follow success patterns for SAFe® implementations adapted to the government context Build a preliminary outline of next steps to begin and / or accelerate the SAFe® implementation in your program or agency Advancing Lean-Agile in government Embracing a Lean-Agile mindset Understanding SAFe® Principles Creating high-performing Agile teams and programs Planning with cadence and synchronization Delivering value in Program Increments Mapping the path to agency and program agility Leading successful change

Learn the basics of calligraphy using the foundational hand with local artist Panna Chauhan at The Arienas Collective and create a framed abstract piece to take home.

This training is designed for lawyers and covers key topics to ensure compliance with the Specialist Quality Mark (SQM) and other regulations.

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

Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 19 Points Development Level Develop

Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 19 Points Development Level Develop

If you got a call from a TV producer asking you to appear on Newsnight, would you say ‘yes’? And if you did, could you make your argument in a way that captured the attention of the audience without being interrupted? Our media training courses are aimed at senior spokespeople and experts who give interviews on TV, radio or in print. We equip them with the skills and confidence to take control and give engaging, memorable and effective performances in which they deliver their key messages, no matter what the circumstances. Highly interactive and practical, each course includes a series of realistic print, radio and television exercises with experienced journalists. We provide immediate feedback following each interview, including techniques for improvement, advice about potential answers and the framing of key messages. While all our media training courses are bespoke, on a typical course we will cover: how the media operates how to prepare for interviews the differences between TV, radio and print interviews how to conduct different types of interview, such as pro-active, reactive, expert commentator and hostile (crisis communications) developing key messages which convey your views persuasively how to take control of an interview, stick to your own agenda and deliver key messages successfully use of language, body language, dress and delivery After the course, each delegate receives the Rough House Media Toolkit, including written feedback, recorded copies of their interview exercises, the Rough House Media Guide to Interviews and further supporting materials. We also provide a confidential assessment to the PR team of each delegate’s suitability for different types of interview. Venue We deliver courses in the most appropriate format for your circumstances – whether face to face or online. Face to face courses are portable: they can be held in purpose-built studios, at your own offices or at an external venue. In the latter two cases, we create a mock studio for the practical exercises. Online courses give you flexibility and enable you to offer training to delegates from all over the world. We have run virtual courses for people from the Far East, South Asia, North America and Europe, as well as the UK.

Duration 2 Days 12 CPD hours This course is intended for Professionals who manage teams and desire to understand what leads to conflict, help peacefully navigate team members through potentially antagonistic situations, encourage and empower others to disagree respectfully and productively, and effectively manage disputes between team members will benefit from this course. Overview Identify and manage sources of conflict Define an effective strategy to deal with conflict Implement a process to manage conflict situations Build civility in the workplace In this course, students will learn to recognize the warning signs that precede quarrels and how to mitigate their impact, as well as constructive ways to harness the differences between team members and shift them toward productive, positive outcomes. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. Understanding conflict Identifying the Causes of Conflict Harnessing the Benefits of Conflict Resolving Conflict Understanding the Key People in Conflict Resolution 2. Civility in the Workplace Recognizing Uncivil Behavior Reaping the Benefits of Civil Behavior Working with Difficult People Identifying and Avoiding Incivility Creating, Implementing, and Enforcing a Civility Policy 3. Conflict Resolution Process Making an Effective Atmosphere Developing Mutual Understanding Focusing on individual and Shared Needs Getting to the Root Cause Generating Options Building a Solution 4. Conflict Resolution Strategies Differentiating Resolution Strategy Versus Process Recognizing the Advantages and Disadvantages to Collaborating, Competing, Compromising, and Avoiding Additional course details: Nexus Humans Constructive Conflict Management 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 Constructive Conflict Management 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.