881 Ada courses

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

ITIL® 4 Foundation: In-House Training ITIL® 4 is built on the established core of best practice in the ITIL® guidance. ITIL® 4 provides a practical and flexible approach to move to the new world of digital transformation and embrace an end-to-end operating model for the delivery and operation of products and services. ITIL® 4 also provides a holistic end-to-end picture that integrates frameworks such as Lean IT, Agile, and DevOps. The ITIL® 4 Foundation is based on the exam specifications specified by AXELOS for the ITIL® 4 Foundation certification. The fundamental objective of this course is to help the participants understand the key concepts of service management and the ITIL® 4 service management framework and prepare for the ITIL® 4 Foundation exam. In addition, this course offers a rich learning experience that helps the participants relate ITIL® to their own work environment. The course includes a case study (based on a fictitious organization, 'Axle Car Hire') that will help the participants understand and experience the ITIL® guiding principles, service value, practices through real-world challenges and opportunities. The rich learning experience is supported by additional learning tools such as pre-course reading materials, post-course reading material, and a set of quick reference cards. What You Will Learn At the end of this program, you will be able to: Understand the key concepts of ITIL® service management Understand how ITIL® guiding principles can help an organization to adopt and adapt ITIL® service management Understand the four dimensions of ITIL® service management Understand the purpose and components of the ITIL® service value system, and activities of the service value chain, and how they interconnect Understand the key concepts of continual improvement Learn the various ITIL® practices and how they contribute to value chain activities Course Introduction Let's Get to Know Each Other Course Overview Course Learning Objectives Course Structure Course Agenda Introduction to IT Service Management in the Modern World Introduction to ITIL® 4 Structure and Benefits of ITIL® 4 Case Study: Axle Car Hire Case Study: Meet the Key People at Axle Case Study: The CIOs Vision for Axle Exam Details ITIL® 4 Certification Scheme Service Management - Key Concepts Intent and Context Key Terms Covered in the Module Module Learning Objectives Value and Value Co-Creation Value: Service, Products, and Resources Service Relationships Value: Outcomes, Costs, and Risks Exercise: Multiple-Choice Questions The Guiding Principles Intent and Context Identifying Guiding Principles Key Terms Covered in the Module Module Learning Objectives The Seven Guiding Principles Applying the Guiding Principles Exercise: Multiple-Choice Questions The Four Dimensions of Service Management Intent and Context The Four Dimensions Key Terms Covered in the Module The Four Dimensions and Service Value System Module Learning Objectives Organizations and People Information and Technology Partners and Suppliers Value Streams and Processes External Factors and Pestle Model Exercise: Multiple-Choice Questions Service Value System Intent and Context Service Value System and Service Value Chain Module Learning Objectives Overview of Service Value System Overview of the Service Value Chain Exercise: Multiple-Choice Questions Continual Improvement Intent and Context Key Terms Covered in the Module Introduction to Continual Improvement Module Learning Objectives The Continual Improvement Model Relationship between Continual Improvement and Guiding Principles Exercise: Multiple-Choice Questions The ITIL® Practices Intent and Context ITIL® Management Practices Key Terms Covered in the Module Module Learning Objectives The Continual Improvement Practice The Change Control Practice The Incident Management Practice The Problem Management Practice The Service Request Management Practice The Service Desk Practice The Service Level Management Practice Purpose of ITIL® Practices Exercise: Crossword Puzzle

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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

DASA DevOps Professional: Enable and Scale DevOps embodies both cultural changes and practices through which organizations can facilitate the IT functions of software development (Dev) and software operation (Ops). The DevOps movement advocates automation and phase-based monitoring practices. Its objectives include: Decreasing development cycles · Increasing deployment frequency Improving the reliability of releases Developing a closer alignment with business objectives The DASA DevOps Professional: Enable and Scale course (formerly known as DevOps Practitioner) is designed to provide individuals with the core education necessary to put DevOps into practice. With the help of DevOps theory, pragmatic examples and exercises, and interactive group discussions, the course will help you understand how to apply the necessary skills to practice DevOps. Building on the knowledge learned on theFundamentals course (the 'why'), you will learn the 'how'. The DevOps Professional: Enable and Scale course focuses on improving the skill set of the DASA competency model, which includes competencies like Courage, Teambuilding, DevOps Leadership, and Continuous Improvement. On completion of the DASA DevOps Professional: Enable and Scale training and passing the exam, the certification is awarded. What you will Learn At the end of this program, you will be able to: Explain the importance of DevOps culture and the aspects that can influence it Explain why courage, teambuilding, leadership, and continuous improvement are required in a DevOps environment Explain why courage is essential to enable trust, honesty, and experimentation Identify and evaluate different types of behavior in a DevOps environment Recognize the signals indicating impediments and/or team dysfunctions Describe how to form good DevOps teams and assess their maturity List the effects of happiness and motivation on team performance Identify how leaders encourage feedback and transparency Discuss the factors that leaders can influence to build trust Explain how and why leaders promote a 'safe to fail' environment Analyze value streams to improve throughput and flow Facilitate the tools for continuous improvement: structured problem-solving workshops, Story Mapping sessions, and retrospectives TEAMBUILDING Teambuilding is about understanding the other's point of view, collaboration, mutual accountability, common purpose, and the ability to integrally support the service/product. Design Teams Characteristics of a DevOps team Skills of a DevOps Team Self-organization and autonomy Rules to consider when designing DevOps teams Build Teams Effects of happiness and motivation on performance Feedback Creating high-performance teams Governance Governance within teams and between multiple teams Governance between organizations DevOps contracts DEVOPS LEADERSHIP This module describes how to facilitate teams to high performance, DevOps behavior, transparency, and a service lifecycle mindset. Build Culture Creating the right environment and providing vision and purpose Stimulating the right behavior Servant leadership: giving control, supporting, and inspiring Create Purpose Defining and aligning purpose Purpose of having a purpose Alignment versus autonomy Be a Servant Leader Give control to the team Inspire and support the team Focus on Success Output versus outcome Measuring and steering COURAGE The Courage module is about coaching courageous behavior, proactivity, reflection, trust, open discussions, experimentation, fail fast, and the courage to change. Build Courage The importance of courage Courage in relationship with leadership and feedback Enabling courage at the team level Dealing with failure Think Different Courage day to day Encourage critical thinking Techniques to promote courageous behavior VALUE CUSTOMER-CENTRIC ACTION This module describes the important aspects that are relevant to identify and deliver the required and expected value for all relevant stakeholders. Aspects of Value and Managing Expectations The different aspects of value Stakeholder management Customer collaboration and using customer feedback How to do prioritization CONTINUOUS IMPROVEMENT Continuous improvement describes the importance of a Kaizen mindset, quality at the source, first time right, knowledge-sharing, and the ability to adapt. Build Flow Understanding the importance of flow Using Lean to optimize flow Kaizen as a mindset Radical change versus Kaizen Using Pull to optimize flow Continuous Improvement Tools Kaizen Event Value Stream Mapping Visual Management Retrospective Daily Standup Five Times Why

Gain expertise in healthcare training with our Level 3 Endorsed Award in Delivering Health and Social Care Training. Our comprehensive program equips you with the skills and knowledge to become a proficient trainer in the healthcare sector.

LEARN CLAIRE RAYMOND'S AWARD-WINNING WINGING IT! SMOKEY EYELINER TECHNIQUE FROM WORLD MASTER ARTIST @CLAIRE.RAYMONDPMU.

SAFe® for Government: In-House Training 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

Landscape training face to face training customised and bespoke.

DASA DevOps Professional: Enable and Scale: In-House Training DevOps embodies both cultural changes and practices through which organizations can facilitate the IT functions of software development (Dev) and software operation (Ops). The DevOps movement advocates automation and phase-based monitoring practices. Its objectives include: Decreasing development cycles · Increasing deployment frequency Improving the reliability of releases Developing a closer alignment with business objectives The DASA DevOps Professional: Enable and Scale course (formerly known as DevOps Practitioner) is designed to provide individuals with the core education necessary to put DevOps into practice. With the help of DevOps theory, pragmatic examples and exercises, and interactive group discussions, the course will help you understand how to apply the necessary skills to practice DevOps. Building on the knowledge learned on theFundamentals course (the 'why'), you will learn the 'how'. The DevOps Professional: Enable and Scale course focuses on improving the skill set of the DASA competency model, which includes competencies like Courage, Teambuilding, DevOps Leadership, and Continuous Improvement. On completion of the DASA DevOps Professional: Enable and Scale training and passing the exam, the certification is awarded. What you will Learn At the end of this program, you will be able to: Explain the importance of DevOps culture and the aspects that can influence it Explain why courage, teambuilding, leadership, and continuous improvement are required in a DevOps environment Explain why courage is essential to enable trust, honesty, and experimentation Identify and evaluate different types of behavior in a DevOps environment Recognize the signals indicating impediments and/or team dysfunctions Describe how to form good DevOps teams and assess their maturity List the effects of happiness and motivation on team performance Identify how leaders encourage feedback and transparency Discuss the factors that leaders can influence to build trust Explain how and why leaders promote a 'safe to fail' environment Analyze value streams to improve throughput and flow Facilitate the tools for continuous improvement: structured problem-solving workshops, Story Mapping sessions, and retrospectives TEAMBUILDING Teambuilding is about understanding the other's point of view, collaboration, mutual accountability, common purpose, and the ability to integrally support the service/product. Design Teams Characteristics of a DevOps team Skills of a DevOps Team Self-organization and autonomy Rules to consider when designing DevOps teams Build Teams Effects of happiness and motivation on performance Feedback Creating high-performance teams Governance Governance within teams and between multiple teams Governance between organizations DevOps contracts DEVOPS LEADERSHIP This module describes how to facilitate teams to high performance, DevOps behavior, transparency, and a service lifecycle mindset. Build Culture Creating the right environment and providing vision and purpose Stimulating the right behavior Servant leadership: giving control, supporting, and inspiring Create Purpose Defining and aligning purpose Purpose of having a purpose Alignment versus autonomy Be a Servant Leader Give control to the team Inspire and support the team Focus on Success Output versus outcome Measuring and steering COURAGE The Courage module is about coaching courageous behavior, proactivity, reflection, trust, open discussions, experimentation, fail fast, and the courage to change. Build Courage The importance of courage Courage in relationship with leadership and feedback Enabling courage at the team level Dealing with failure Think Different Courage day to day Encourage critical thinking Techniques to promote courageous behavior VALUE CUSTOMER-CENTRIC ACTION This module describes the important aspects that are relevant to identify and deliver the required and expected value for all relevant stakeholders. Aspects of Value and Managing Expectations The different aspects of value Stakeholder management Customer collaboration and using customer feedback How to do prioritization CONTINUOUS IMPROVEMENT Continuous improvement describes the importance of a Kaizen mindset, quality at the source, first time right, knowledge-sharing, and the ability to adapt. Build Flow Understanding the importance of flow Using Lean to optimize flow Kaizen as a mindset Radical change versus Kaizen Using Pull to optimize flow Continuous Improvement Tools Kaizen Event Value Stream Mapping Visual Management Retrospective Daily Standup Five Times Why