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
Duration 2 Days 12 CPD hours This course is intended for Executives, directors, managers, and others tasked with making important decisions for their organizations will benefit from this course. Overview Make intelligent decisions with limited time and information Reframe issues to ensure greater problem-solving accuracy Convert conflicting opinions into useful insights In this course, students will learn to evaluate options, generate possible solutions, and decide on logical strategies. 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. Prerequisites While there are no prerequisites for this course, please ensure you have the right level of experience to be successful in this training. 1. The Complexity of Decision Making Establishing the Needs of the Organization Defining Organizational Objectives and Goals Measuring Your Goals Calculating Probabilities of Success 2. Dealing with Opinion in the Face of Uncertainty Understanding Theories of Decision-Making Avoiding Irrationality Being Aware of Risks Reframing the Options Asking the Right Questions Knowing What You Want Making Proper Comparisons Working with Stereotypes and Expectations 3. Adapting Decision Strategies for a Complex World Reviewing Your Plans Engaging Stakeholders Enlisting Your Network Managing Risks Planning for Risks - Avoidance, Mitigation, Transference, and Acceptance Applying Complexity Theory and the Butterfly Effect Adjusting Decisions Building in Metrics & Measurements Monitoring Progress and Managing Risks Looking for Emerging Trends Additional course details: Nexus Humans Making the Right Decisions Under Pressure 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 Making the Right Decisions Under Pressure 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.
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
Duration 2 Days 12 CPD hours This course is intended for Anyone desiring to improve their ability to speak self-assuredly, in front of both internal and external groups will benefit from this course. Overview Understand what separates an effective presentation from an ineffective presentation. Design a proficient presentation geared toward their audience. Create powerful slides that enhance the address. Enhance their public speaking skills with tips and techniques used by professional speakers. Prepare mentally for their best performance. Engage their audience more effectively and with greater passion. Whether speaking publicly or to a specific audience, your ability to build, develop and deliver a purposeful presentation is key to being able to convey your message and achieve your desired results. From open to close, it is crucial to learn the tools necessary to maintain engagement and to organize ideas to create coherent and convincing oral presentations. In this course, you will learn strategies to structure and develop presentation content focused on audience need and key points, identifying the areas in which you are most polished, as well as picking up hints and tips to address any gaps. 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. Foundation, Structure, and Organization Why a presentation The difference between effective and ineffective presentations Delivering passion and value Structure determines success 2. Creating the Basic Structure Building the backbone Capturing audience attention Understanding your audience 3. Organizing Your Program Planning analog Creating the topic outline Fact-Finding 4. Designing and Building Your Presentation Choosing proper content Building and writing Your presentation Slide design 5. Delivering Your Presentation Preparing mentally Appearing confident in front of the crowd 6. Engaging Your Audience from Start to Finish Understanding and matching learning styles Closing Your presentation and providing calls to action Additional course details: Nexus Humans The Art of Effective Presentations (Second Edition) 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 The Art of Effective Presentations (Second Edition) 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.
Duration 2 Days 12 CPD hours This course is intended for The target audience for the DevSecOps Foundation course are professionals including: Anyone involved or interested in learning about DevSecOps strategies and automation Anyone involved in Continuous Delivery toolchain architectures Compliance Team Business managers Delivery Staff DevOps Engineers IT Managers IT Security Professionals, Practitioners, and Managers Maintenance and support staff Managed Service Providers Project & Product Managers Quality Assurance Teams Release Managers Scrum Masters Site Reliability Engineers Software Engineers Testers Overview You will learn: The purpose, benefits, concepts, and vocabulary of DevSecOps How DevOps security practices differ from other security approaches Business-driven security strategies and Best Practices Understanding and applying data and security sciences Integrating corporate stakeholders into DevSecOps Practices Enhancing communication between Dev, Sec, and Ops teams How DevSecOps roles fit with a DevOps culture and organization In this course, students will gain a solid understanding of how DevSecOps provides business value, enhancing your business opportunities, and improving corporate value. The core DevSecOps principles taught can support an organizational transformation, increase productivity, reduce risk, and optimize resource usage. This course explains how DevOps security practices differ from other approaches then delivers the education needed to apply changes to your organization. Participants learn the purpose, benefits, concepts, vocabulary and applications of DevSecOps. Most importantly, students learn how DevSecOps roles fit with a DevOps culture and organization. At the course?s end, participants will understand ?security as code? to make security and compliance value consumable as a service. This course prepares you for the DevSecOps Foundation (DSOF) certification. Realizing DevSecOps Outcomes Origins of DevOps Evolution of DevSecOps CALMS The Three Ways Defining the Cyberthreat Landscape What is the Cyber Threat Landscape? What is the threat? What do we protect from? What do we protect, and why? How do I talk to security? Building a Responsive DevSecOps Model Demonstrate Model Technical, business and human outcomes What?s being measured? Gating and thresholding Integrating DevSecOps Stakeholders The DevSecOps State of Mind The DevSecOps Stakeholders What?s at stake for who? Participating in the DevSecOps model Establishing DevSecOps Best Practices Start where you are Integrating people, process and technology and governance DevSecOps operating model Communication practices and boundaries Focusing on outcomes Best Practices to get Started The Three Ways Identifying target states Value stream-centric thinking DevOps Pipelines and Continuous Compliance The goal of a DevOps pipeline Why continuous compliance is important Archetypes and reference architectures Coordinating DevOps Pipeline construction DevSecOps tool categories, types and examples Learning Using Outcomes Security Training Options Training as Policy Experiential Learning Cross-Skilling The DevSecOps Collective Body of Knowledge Preparing for the DevSecOps Foundation certification exam Additional course details: Nexus Humans DevSecOps Foundation (DevOps Institute) 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 DevSecOps Foundation (DevOps Institute) 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.
Duration 2 Days 12 CPD hours This course is intended for Professionals wishing to maximize their productivity and efficiency by investing their time more effectively will benefit from this course. Overview Time Management Prioritization Organization Workflow Productivity Time is limited, so getting the most out of every minute is critical. In this course, students will learn to improve their focus, prioritize tasks, identify and avoid obstacles to staying on track, and develop strategies to get the most out of their time. Students will acquire time management tools and decision-making techniques to help focus on purpose and achieve your goals, balancing the needs of both business and personal life. 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. Wise Time Management Identifying Time Wasters Applying the 80/20 Rule Utilizing Calendars Creating Rituals 2. Prioritizing Your Time Taking Charge of Your Time Protecting Your Time through Assertiveness 3. Planning Wisely Managing the Power of Your Productivity Journal Finding Hidden Time Chunking, Blocking, and Tackling 4. Organizing Your Workspace Decluttering Managing Workflow Taking Control over Email 5. Tackling Procrastination Knowing Why You Procrastinate Nine Ways to Avoid Procrastination 6. Crisis Management Weathering the Storm Creating and Executing a Plan Applying Lessons Learned 7. Increase Your Productivity Applying Productivity Tools Finding What Works Eliminating the Word \'Should\' Building on Success Additional course details: Nexus Humans Prioritizing Your Time Effectively 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 Prioritizing Your Time Effectively 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.
Duration 2 Days 12 CPD hours This course is intended for Professionals desiring to be able to communicate clearly and concisely in their writing will benefit from this course. Overview Awareness of common spelling and grammar issues in business writing. Basic concepts in sentence and paragraph construction. Basic structure of agendas, email messages, business letters, business proposals, and business reports. Collaborative writing techniques, tools and best practices Tips and techniques to use when deciding the most appropriate format to use for agendas, email messages, business letters, business proposals, and business reports In this course, you will learn the essential skills needed to organize your thoughts and select the best words and phrases to clearly convey them in writing. 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. Working With Words Monitoring Spelling, Grammar, and Verb Tense Creating a Reference Sheet 2. Constructing Sentences Recognizing Sentence Parts Classifying Sentence Type Increasing Readability with Punctuation 3. Creating Paragraphs The Three Basic Components Organization Methods 4. Finding Facts Identifying and Using Key Resources Fact-Finding and Information Gathering 5. Collaborative Writing Clarifying the Objective Collaborative Writing Strategies and Patterns 6. Types of Collaborative Business Writing Applying Different Construction Techniques Cut & Paste, Puzzle, Sequential Summative Integrating Construction 7. Collaborative Tools and Processes Planning and Revision Creating Outlines and Storyboards Building Team Cohesion 8. Writing Meeting Agendas Choosing an Agenda Format Structuring and Writing the Agenda 9. Writing E-Mails, Reports and Proposals Addressing Your Message Using Proper Grammar and Defining Acronyms Structuring, Formatting, and Writing Your Report Additional course details: Nexus Humans Writing for the Business Professional 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 Writing for the Business Professional 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.
APM Project Fundamentals Qualification (PFQ): Virtual In-House Training This practical course gives Participants a solid introduction to the fundamentals of project management and to prepare them for the one-hour, multiple-choice exam held at the end of the course. The APM Project Fundamentals Qualification (PFQ) is an entry-level qualification suitable for those who are new to project management and working in a project team, and who wish to understand the standard terminology. The goal of this course is to prepare you to successfully pass the exam. What you will Learn You'll learn how to: Identify project management terminology and context Identify project management processes Identify the roles involved in project management Describe project success criteria and benefits Prepare project documentation Acquire the level of understanding needed to pass the APM PFQ examination Getting Started Introductions Course structure Course goals and objective Project Context Project characteristics Project management processes Business and project context Organizational roles Project Lifecycle Programme and portfolio management Project Concept Phase Stakeholder management Project success and benefits management Business case Benefits People in Projects Leadership and teamwork Communication Project Definition Phase Project management plan Quality management Risk management Scope management Scheduling Resource management Estimating Procurement Project Implementation Phase Change control and configuration management Issue management Information management Project Hand-over and Close-out Phase Hand-over and close-out Post-project review Revision and Exam Revision and practice questions APM PFQ examination
Leading SAFe®: In-House Training During this course, attendees gain the knowledge necessary to lead a Lean-Agile enterprise by using the Scaled Agile Framework® (SAFe®) and its underlying principles derived from Lean, systems thinking, Agile development, product development flow, and DevOps. Participants in the class gain insights into mastering business agility to thrive in competitive markets. They discuss how to establish team and technical agility and organize and re-organize around the flow of value. Attendees also learn and practice the skills to support and execute PI Planning events and coordinate multiple Agile Release Trains (ARTs). Class participants will explore the importance of adopting a customer-centric mindset and Design-Thinking approach to Agile Product Delivery. Learners will also understand how to implement a Lean Portfolio Management function within their enterprise. What you will Learn After attending this class, attendees should be able to: Lead the transformation to business agility with SAFe® Become a Lean-Agile leader Understand customer needs Design Thinking Enable Agile Product delivery Implement Lean Portfolio Management Thrive in the digital age with business agility Become a Lean-Agile leader Establish Team and Technical Agility Build solutions with Agile Product Delivery Explore Lean Portfolio Management Lead the change Become a Certified SAFe® Agilist
Leading SAFe® During this course, attendees gain the knowledge necessary to lead a Lean-Agile enterprise by using the Scaled Agile Framework® (SAFe®) and its underlying principles derived from Lean, systems thinking, Agile development, product development flow, and DevOps. Participants in the class gain insights into mastering business agility to thrive in competitive markets. They discuss how to establish team and technical agility and organize and re-organize around the flow of value. Attendees also learn and practice the skills to support and execute PI Planning events and coordinate multiple Agile Release Trains (ARTs). Class participants will explore the importance of adopting a customer-centric mindset and Design-Thinking approach to Agile Product Delivery. Learners will also understand how to implement a Lean Portfolio Management function within their enterprise. What you will Learn After attending this class, attendees should be able to: Lead the transformation to business agility with SAFe® Become a Lean-Agile leader Understand customer needs Design Thinking Enable Agile Product delivery Implement Lean Portfolio Management Thrive in the digital age with business agility Become a Lean-Agile leader Establish Team and Technical Agility Build solutions with Agile Product Delivery Explore Lean Portfolio Management Lead the change Become a Certified SAFe® Agilist