ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach. About This Course Learning Objectives Understand the elements and operations of a Medical Devices Quality Management System (MDQMS) Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand the approaches, methods and techniques used for the implementation and management of a MDQMS Course Agenda Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 Day 2: Medical Devices Quality Management System requirements and Certification Exam Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites None What's Included? Certification fees are included on the exam price Training material containing over 200 pages of information and practical examples will be distributed An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend? Individuals involved in Medical Devices Quality Management Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS) Individuals interested to pursue a career in Medical Devices Quality Management Accreditation Provided by This course is Accredited by NACS and Administered by the IECB
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Managing Complex Projects: Virtual In-House Training As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environment As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. Complex projects don't necessarily follow the rules of traditional projects - in many instances the projects' end-products, and the methods by which they will be produced, are not easily defined. Stakeholder diversity and geographical dispersion contribute to the difficulties project managers face in their efforts to gain acceptance of project goals, objectives, and changes. Additionally, hierarchic leadership styles, traditional lifecycle approaches, and traditional project manager competencies may no longer maximize the efficiencies that need to be realized on complex projects. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environments. What you Will Learn The learning objectives of this workshop are to enable participants to: Appreciate complexity and its impact on the management of projects Describe the differences among traditional, complicated, and complex projects Explain the effects of complexity on the PMBOK® Guide's process groups Apply a high-level model in the management of real- world projects Complexity and Projects Some characteristics of complex systems Important models/characteristics of complex projects Major players in project complexity Landscapes and project typologies A supplemental framework for complex projects Framing Framing overview Potential pitfalls in framing complex projects Possible solutions Inception Centrality of risk management PM competencies, selection Stakeholder identification, analysis Blueprint Collaborative planning Stakeholder engagements Alternative methodologies/life cycles Collaborative scheduling Procurement management Oversight, Navigation, and Adjustment Leadership and the project team Stakeholder management Networks Close and Continuous Improvement Transition/support Post-project evaluations Rewards/Recognition
Project Estimating and Scheduling: Virtual In-House Training Establishing realistic estimates and goals for projects that support business objectives and meet client expectations is one of the most challenging aspects of project planning. Delivering those results within the agreed-upon time, cost, and quality constraints is also challenging. Attempting to meet impossible deadlines with limited budgets often leads to unplanned product shortfalls, causing long-term support and utilization problems. We have all anguished about this recurring problem, but without having the skills or knowledge to take action, we are unable to break the cycle! The goal of this course is for you to be able to support business objectives and meet client expectations by selecting the right planning approach for realistic and cost effective schedules, as well as project budgets. To achieve that, you will focus on gaining the necessary knowledge, skills, and techniques. What You Will Learn At the end of this program, you will be able to: Use the work breakdown structure (WBS) as the basis for effective estimating of project resources Estimate effort and duration using a variety of techniques Develop preliminary schedules using the critical path method Apply a variety of optimization techniques to refine preliminary schedules Establish realistic schedule and cost baselines, with appropriate contingency reserves Explain how earned value management (EVM) contributes to control time and cost performance Foundation Concepts Project management basic definitions and concepts PES Key driver: competing constraints PES Process and success factors Project Definition and the WBS Project definition overview Work Breakdown Structure (WBS) Decomposition: WBS development technique Resource Planning Resource planning overview Identifying resource requirements Identifying and filling resource gaps Applying resource planning tools Effort and Duration Estimating Estimating overview Estimating perspectives and approaches Estimating techniques Effort and duration estimating best practices Project Scheduling Overview of project scheduling Dependencies and the project network diagram Critical path method (CPM) Optimizing the schedule Budget, Risk, and Contingency Planning Overview of budget, risk, and contingency planning Estimating costs Determining the budget Project risk management processes Planning contingency reserves Project Baseline and Control Overview of project baseline Negotiating and the project baseline Earned value management (EVM) Project variances and actions Project control
Conflict Resolution Skills (Virtual) Many organizations have assumed that workplace conflict is always destructive. So, they have often believed that conflict is best dealt with by managers or even via policies and procedures. After all, conflict creates workplace stress and leads to many performance problems, generating very real organizational costs! However, savvy organizations have embraced the fact that when conflict is understood and harnessed, it can be leveraged to add value to teams and even enhance performance. With the right knowledge, skills, training, and practice, conflict can be productive and make organizations better! In this highly interactive course, learners will discover the connection between individual conflict response and team-empowering conflict resolution skills. Participants will explore conflict's visceral dynamics and the nuanced behaviors we individually engage in to communicate and respond to conflict. Learners will apply techniques for transforming unproductive conflict responses into productive ones. Additionally, learners will use a systematic method that prepares them to objectively dissect real-world conflict, while practicing many strategies for resolving it. They will also develop proactive conflict approach plans, which they can transfer back to their own workplaces. What you will Learn At the end of this program, you will be able to: Recognize the organizational costs of conflict Explain our physical and mental responses to conflict Communicate proactively and effectively with different types of people during conflict Replace unproductive conflict responses with productive ones Use the Conflict Resolution Diagram (CRD) process and conflict resolution approaches Relate team stages of development to shifts in conflict Develop a proactive conflict approach for your organization Create a conflict resolution plan for a real-world scenario Getting Started Introductions and social agreements Course goal and objectives Opening activities Conflict Facilitation Readiness Conflict responses and perceptions Conflict basics Conflict and organizations Dynamics of conflict Conflict Styles and Communication A look at the color energies model Conflict through the color energies and DiSC® lens Communication with opposite color energies Individual Response to Conflict The anatomy of conflict Recognizing unproductive conflict responses 4 steps to productive conflict Choosing productive conflict responses Team Performance and Conflict High-performing team relationships Conflict and project team performance Conflict Resolution Diagram (CRD) and process Conflict Facilitation - Preparation Recognizing context and stakeholder needs Using team conflict resolution approaches Preparing for Crucial Conversations® Conflict Facilitation - Clarity Exposing assumptions and biases Defining the conflict and using the CRD Conflict Facilitation - Action Proactive conflict management Conflict facilitation practice Summary and Next Steps Review Personal action plans
During this live-online masterclass we will focus on understanding recent developments in the mental health and wellbeing of children in the UK, including looking at the impact of cultural and technological changes over recent years and the impact this is having in schools.
Effecting Business Process Improvement: Virtual In-House Training Business analysts facilitate the solution of business problems. The solutions are put into practice as changes to the way people perform in their organizations and the tools they use. The business analyst is a change agent who must understand the basic principles of quality management. This course covers the key role that business analysts play in organizational change management. What you will Learn You will learn how to: Define and document a business process Work with various business modeling techniques Perform an enterprise analysis in preparation for determining requirements Analyze business processes to discern problems Foundation Concepts Overview of business analysis and process improvement Defining the business process Introducing the proactive business analyst Focusing on business process improvement for business analysts Launching a Successful Business Process Improvement Project Overview of the launch phase Understanding and creating organizational strategy Selecting the target process Aligning the business process improvement project's goals and objectives with organizational strategy Defining the Current Process Overview of current process phase Documenting the business process Business modeling options: work-flow models Business modeling options: Unified Modeling Language (UML) model adaptations for business processes Analyzing the Current Process Process analysis overview Evaluation: establishing the control group Opportunity techniques: multi-discipline problem-solving Opportunity techniques: matrices Building and Sustaining a Recommended Process Overview of the recommended process and beyond Impact analysis Recommended process Transition to the business case Return to proactive state
Developing the Business Case: Virtual In-House Training Business analysts must be able to create business case documents that highlight project benefits, costs, and risks. The business case is based on the real business need to be solved. These become parts of proposals, feasibility studies, and other decision support documents. This course teaches the purpose, structure, and content of a business case. It presents the basic techniques for determining financial ROI, non-tangible benefits, and the probability of meeting expectations. What you will Learn At the end of this program, you will be able to: Perform feasibility studies Justify the business investment to solve the business problem Prepare an effective business case document Plan and implement a business case approval process Foundation Concepts The role of the BA An introduction to the BABOK® Guide The business analyst and the product / project life cycle (PLC) The business case deliverable Introducing the Business Case Process The BA and strategy analysis The BA and the business case process (BCP) The BA during the business case process (BCP) The BA after the business case process (BCP) Importance of defining solution performance metrics Defining the Business Need Overview of defining the business need Business needs: problem / opportunity statement Product vision Objectives and constraints Exploring Business Case Solutions Overview of exploring solutions Solution identification for feasibility Solution definition for analysis Assessing project risks Justifying the Business Case Overview of justifying the business case Qualitative justification Quantitative justification Approving the Business Case Overview of business case approval Developing recommendations Preparing the decision package - documents Preparing the decision package - presentations
Scrum Master Workshop: In-House Training: Virtual In-House Training A Scrum Master helps project teams properly use the Scrum framework, increasing the likelihood of the project's overall success. Scrum Masters understand Scrum values, practices, and applications and provide a level of knowledge and expertise above and beyond that of typical project managers. Scrum Masters act as 'servant leaders', helping the rest of the Scrum Team work together and learn the Scrum framework. Scrum Masters also protect the team from both internal and external distractions. What you will Learn You'll learn how to: Comprehend the Agile Manifesto and mindset Explain the fundamental principles of Scrum Guide the Scrum team in their responsibilities Write requirements in the form of user stories Define Ready and Done Estimate using planning poker and prioritize using MoSCoW Facilitate the team through the 5 Sprint events Fulfill the role of Scrum Master in a Scrum project Create Information Radiators to enable transparency Define the structure of the retrospective Foundation Concepts Agile History, Values, and Mindset Introduction to Scrum Scrum events Scrum artifacts Scrum Roles and Responsibilities Product Owner responsibilities Scrum Master responsibilities The Team responsibilities Cross-functional Teams Building Effective Teams The Product Backlog and User Stories The Product Backlog User Stories Definition of Done Backlog grooming Estimating User Stories Story points, planning poker Prioritizing User Stories The Sprint Team capacity and velocity The Sprint Planning Meeting The Sprint Backlog The Sprint Learning to self-manage, self-organize, self-improve Sprint Review and Retrospective Project Progress and Completion The Daily Scrum The Task Board and The Burndown Chart Information Radiators Closing a Scrum Project Summary and Next Steps Review of course goals, objectives, and content
Strategic Thinking (Virtual) The goal of this course is to provide you with the building blocks and the motivation to develop the critical skill of strategic thinking. The participants will consider a four-part model that distinguishes strategic thinking from strategic planning and managing. With that understanding, you will investigate the critical components of strategic thinking and how to apply it effectively. What You Will Learn You will learn how to: Define strategic thinking and distinguish it from strategic planning and management Explain a high-level approach to gaining strategic thinking skills Integrate other interpersonal skills, such as self-awareness, systems thinking, leadership, constructive conflict, and collaboration, into the fabric of strategic thinking skills Select appropriate techniques to apply strategic thinking in specific situations Recognize and emulate effective strategic thinking behaviors Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Interactive event: Define Strategic Thinking (ST) Interactive event: Discuss relationship of ST with Strategic Planning, Management and Decision Making Strategic Level Framework - Tying it all together Strategic thinking attributes Strategic Thinking Critical Success Factors Strategic Thinking Critical Success Factors - 5-part model Strategic Thinking and the Organization Critical Success Factors Model applied to an organization Tools Introduction (5): Environmental, 5 Forces, SWOT, Value Proposition, Integral Theory of Worldview Video: Fog of War Strategic Thinking and the Individual Critical Success Factors Model applied to an individual Tools Introduction (5): Thinking Styles, Six Thinking Hats, Reverse Thinking, Systems Thinking, Integral Theory of Worldview Strategic Thinking at the Interpersonal and Team Levels Emotional Intelligence - Self Awareness and Working With Others Team Leadership and Trust Constructive Conflict as the Gateway to Collaboration Interactive event: Testing the Models - Challenge Perspective; What's Missing Applying the critical skill of Strategic Thinking Worldview: Team versus client Trusted Advisor Interactive event: Doing what is asked (Case study, wherein participants review the default case scenario prepared for this workshop and add specific details to make the scenario more relevant to their experiences / needs. Teams develop an action plan for applying ST concepts and techniques they have learned here to the situation, then compare and contrast results.)