63322 Courses

Agile Business Consortium Scrum Master® Course This two-day course covers the principles and theory of the Scrum framework and the role of the Scrum Master. IIL is an accredited training organization (ATO) and the course is delivered by accredited trainers. APMG's accreditation processes are respected globally and accredited by UKAS. A Scrum Master is responsible for promoting and supporting Scrum as defined in The Scrum Guide, and also is the leader who serves the Product Owner, the Development Team, and the Organization. Why APMG - Agile Business Consortium Scrum Master® Course and Certification? The course, syllabus, and learning objectives are based on The Scrum Guide - The Definitive Guide to Scrum: The Rules of the Game - created and maintained by Scrum's creators Ken Schwaber and Jeff Sutherland Increased business (non-IT) focus of course and exercises Developed in partnership with Agile Business Consortium - leaders in promoting and enabling business agility Course is highly interactive to encourage collaboration and reinforce learning objectives Candidates can sit the examination at the end of the training course No recertification requirements. APMG Scrum Master certification does not expire. Successful candidates are entitled to free 1-year membership with the Agile Business Consortium Successful candidates can claim a digital badge and share their success online What You Will Learn At the end of this program, you will be able to: Gain a deep understanding of the Scrum Framework - the theory, practices, roles, rules, and values - as defined in The Scrum Guide Understand, in detail, the role of Scrum Master, and how the role interacts with different members of the Scrum Team and other stakeholders Master the Scrum principles to better understand their application when returning to the workplace Understand how to construct an effective development team with an appropriate mix of skills and experience Know how to act as a servant-leader for the Scrum Team, promoting and enabling self-organization to create high-value products. Learn how to facilitate Scrum Events and remove impediments to the Scrum Team's progress Help Scrum Product Owners shape and refine product backlogs to guide early and incremental delivery of valuable products Drive adoption of the Scrum framework for more effective product and solution development, working with stakeholders and other Scrum Masters to improve its effectiveness Day One Scrum Overview Self-Organization Agile Principles Empirical Product Development Scrum Events The Development Team Scrum Roles Day Two The Product Backlog Sprint Planning and Done Sprint Progress Scrum Simulation Growing as a Scrum Master

Advanced Certified Scrum Product Owner® (A-CSPO®): In-House Training All Advanced CSPO courses are taught by Educators approved by the Scrum Alliance. Taking an Advanced CSPO course, meeting the learning objectives, and accepting the license agreement designates you as an Advanced Certified Scrum Product Owner. Please review your trainer's course description below to determine which learning objectives this course satisfies. What you will Learn You'll learn to: Manage multiple business initiatives from competing stakeholders Clearly order and express Product Backlog items Define a clear product vision that ensures your product remains focused on the features your customers and end users will actually use Communicate effectively with various stakeholder groups to achieve alignment Identify the crucial opportunities and avoid wasting time Define and validate business value Increase your credibility as a product expert and become recognized as a person who delivers real business results Benefits Build on your foundational knowledge with enhanced implementation skills Distinguish yourself in the global marketplace Stand out in your industry as a member of the Scrum Alliance globally-recognized community Show advanced value to your employer (or potential employer) as a highly trained Agile professional

AgileSHIFT®: In-House Training AgileSHIFT® is the change your organization needs: the business landscape is changing and transformation is necessary. But it is also hard. This program is aimed to drive transformational change throughout an organization. This new enterprise agility guidance empowers individuals to use a lightweight tailorable framework to understand, engage with, and champion change by embracing agile and lean ways of working. Taking a holistic view of an organization, AgileSHIFT® will create and support the champions of change your business needs in order to thrive in an increasingly competitive and disruptive workplace. What You Will Learn At the end of this program you will be able to: Identify why organizations need to create a culture of enterprise agility in response to a changing context Recognize how to think and work differently to enable change Explore agile and lean thinking concepts and how they relate to running and changing your organization Utilize key concepts of the AgileSHIFT® framework Describe the AgileSHIFT® delivery approach Getting Started A changing context Enterprise agility The Purpose of AgileSHIFT® The AgileSHIFT® Framework AgileSHIFT® principles AgileSHIFT® practices AgileSHIFT® roles AgileSHIFT® workflow Benefits of AXELOS.com Summary and Next Steps

SAFe® Product Owner / Product Manager: In-House Training Develop the skillsets needed to guide the delivery of value in a Lean Enterprise by becoming a SAFe® 5.0 Product Owner / Product Manager (POPM). During this course, attendees gain an in-depth understanding of how to effectively perform their role in the Agile Release Train (ART) as it delivers value through Program Increments. Attendees explore how to apply Lean thinking to decompose Epics into Features and Stories, refine Features and Stories, manage Program and Team backlogs, and plan and execute Iterations and Program Increments. Attendees also discover how the Continuous Delivery Pipeline and DevOps culture contribute to the relentless improvement of the ART. What you will Learn To perform the role of a SAFe® Product Owner / Product Manager, attendees should be able to: Articulate the Product Owner and Product Manager roles Connect SAFe® Lean-Agile principles and values to the PO / PM roles Decompose Epics into Features and decompose Features into Stories Manage Program and Team backlogs Collaborate with Agile teams in estimating and forecasting work Represent customer needs in Program Increment Planning Execute the Program Increment and deliver continuous value Becoming a Product Owner / Product Manager in the SAFe® enterprise Preparing for PI Planning Leading PI Planning Executing Iterations Executing the Program Increment Becoming a Certified SAFe® Product Owner / Product Manager

SAFe® Product Owner / Product Manager Develop the skillsets needed to guide the delivery of value in a Lean Enterprise by becoming a SAFe® 5.0 Product Owner / Product Manager (POPM). During this course, attendees gain an in-depth understanding of how to effectively perform their role in the Agile Release Train (ART) as it delivers value through Program Increments. Attendees explore how to apply Lean thinking to decompose Epics into Features and Stories, refine Features and Stories, manage Program and Team backlogs, and plan and execute Iterations and Program Increments. Attendees also discover how the Continuous Delivery Pipeline and DevOps culture contribute to the relentless improvement of the ART. What you will Learn To perform the role of a SAFe® Product Owner / Product Manager, attendees should be able to: Articulate the Product Owner and Product Manager roles Connect SAFe® Lean-Agile principles and values to the PO / PM roles Decompose Epics into Features and decompose Features into Stories Manage Program and Team backlogs Collaborate with Agile teams in estimating and forecasting work Represent customer needs in Program Increment Planning Execute the Program Increment and deliver continuous value Becoming a Product Owner / Product Manager in the SAFe® enterprise Preparing for PI Planning Leading PI Planning Executing Iterations Executing the Program Increment Becoming a Certified SAFe® Product Owner / Product Manager

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

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