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  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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Leading Cross-Cultural Virtual Teams (Virtual) High-performing teams are a must in this world of intense competition and higher expectations. Global virtual teaming has become a necessity as organizations become increasingly distributed and suppliers and clients actively engage in joint projects. Teams work across geographical and organizational boundaries to deliver solutions and services to global users where distance and differences, both geographic and cultural, amplify the effect of issues and factors that are relatively straightforward when managing a team of people in the same location. This course delivers practical concepts and techniques that participants will start using immediately on their global projects. What you will Learn At the end of this program, you will be able to: Define relationships among foundational concepts (leadership and three dimensions of diversity) and explain their potential impacts on project performance Describe key components of successful project leadership and build selected Transformational Leadership skills Prepare to convert project challenges stemming from personal or cultural diversity into potential competitive advantage Implement selected best practices to meet key challenges facing virtual project teams Foster and grow an environment that supports continued success for CCVTs Getting Started Foundation Concepts Basic definitions Critical success factors for leading cross-cultural virtual teams (CCVTs) A roadmap to success for leading CCVTs Leadership Excellence in Any Project Environment Leading effectively in a global environment Transformational leadership The four components of Transformational Leadership Leveraging Personal Diversity Overview of personal diversity Mind styles The theory of multiple intelligences Connecting Transformational Leadership and personal diversity Embracing Cultural Diversity Introduction to cultural intelligence The impact of culture Cultural Dimensions Theory The Culture Map Managing Virtual Diversity Overview of virtual diversity Virtual time management Virtual processes and technology Virtual leadership Creating an Environment for Success Supporting a cross-cultural virtual-team (CCVT-) friendly environment Building a foundation of trust Developing a team charter Recap and review Summary and Next Steps Personal action plan

Project Accounting and Finance Skills: Virtual In-House Training Do you manage both project schedules and budgets, but do not have insight into how actual results relate to the approved budget? Do you desire to have more clarity about the relationship between your project's performance with the accounting and financial systems in your organization? Do you need to understand financial and accounting terminology to bridge the gap between the 'world of finance' and the 'world of project management? Organizations have a need to manage-by-projects, because projects are the means to deliver on strategic goals and objectives. Therefore, the project manager must have an understanding of the financial world of investments to ensure the organization will realize expected business value. This requires a foundation in the principles of accounting and finance to comprehend how the project's contribution provides an organization with a competitive advantage. Learn what you must do to give your organization the assurance it needs that its investment in your project will realize business value. Learn what you must do to give your organization the assurance it needs to know that its investment in your project will realize business value. What You Will Learn At the end of this program, you will be able to: Explain the aspects of classical corporate accounting and finance effects on managing projects Determine how your project fits into the corporate income statement, balance sheet, and cash flow statement Analyze the financial aspects of managing projects Use earned value management as the basis for decision making throughout the project life Recognize the importance of the project manager's financial responsibilities Focus on what PMs do and should be doing, in support of accounting and finance Use financial information within a project environment to meet financial results Track and analyze the project's financial status and forecast with the goal of realizing benefits Generate work performance data to ensure a project's outcome aligns with financial metrics Foundation Concepts Accounting and Finance Terms and Concepts Accounting and Finance Essentials Financial Terms and Concepts Projects as Financial Investments Overview of 'Two Worlds' Project as Investments Accounting and Finance World: Standards, Principles and Practices Accounting and Finance Standards and Principles Accounting and Finance Practices Capital Budgeting Corporate Budgeting Accounting and Finance World: Economic Project Selection Methods Economic Project Selection Methods Economic Project Selection and the Business Case Project Management World Project Management and Financial Controls Project Management and Work Performance Data Project Management and Earned Value Management Project Management and Work Performance Reporting

Managing Multiple Projects: Virtual In-House Training Succeeding in today's competitive marketplace often requires cycle time reduction - reducing the duration of projects and getting results faster. This workshop will address managing multiple projects within the context of program or product management. Are your projects taking longer and longer to complete? Are results less than optimal because of time pressures on resources? Would you like to increase project 'throughout'? Succeeding in today's competitive marketplace often requires cycle time reduction - reducing the duration of projects and getting results faster. This workshop will address managing multiple projects within the context of program or product management. Planning and managing individual projects is challenging. When introducing the real-life limitation of resources and other outside influences into the multi-project environment, those challenges are magnified, and new challenges are introduced. This interactive workshop will position you for immediate action. The goal of this course is to equip you with the necessary knowledge, skills, and techniques so that you can effectively and productively manage multiple projects. What you Will Learn You'll learn how to: Manage stakeholder relationships and expectations Prioritize and sequence multiple projects Manage time and stress within a multiple project environment Effectively manage logical dependencies among projects Optimize the use of resources across multiple projects using concepts from Critical Chain methods Manage risk and communications in a multiple project environment Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Portfolio, program, and project management principles The multiple project environment The MMP Process Model Developing the Multiple Project List Multiple project portfolio management Project selection Project categories and types The multiple project list Multiple Project Logical Dependencies Project dependencies Types of multiple project portfolios Categories of logical dependencies across multiple projects Project priorities in the multiple project schedule Multiple Project Resource Management Multiple project resources and resource management concepts Multiple project resource loading Resource pool and resource database Multiple project resource issues and outsourcing Critical chain resource management, including drum resources and multi-tasking Managing Risk Across Multiple Projects Multiple project risk management process Identifying, assessing, and responding to multiple project risks Critical chain and multiple project risks Risk interrelationship management methods Creating and Executing the Multiple Project Plan The multiple project plan Multiple project scheduling Multiple project budgeting Executing and maintaining the multiple project plan Controlling in the multiple project environment Tools in multiple project management Multiple Project Communications Effective communication in the multiple project environment Common communication barriers Multiple project communications plan Resolving multiple project conflicts Summary and Next Steps What did we learn, and how can we implement this in our work environments?

Earned Value Management: In-House Training: Virtual In-House Training Earned Value Management (EVM) incorporates a set of proven practices appropriate for project or program management methodologies. These include integration of program scope, schedule, and cost objectives, establishment of a baseline plan for accomplishment of program objectives and use of earned value techniques for performance measurement during the execution of a program. Earned Value Management (EVM) incorporates a set of proven practices appropriate for project or program management methodologies. These include integration of program scope, schedule, and cost objectives, establishment of a baseline plan for accomplishment of program objectives and use of earned value techniques for performance measurement during the execution of a program. EVM provides a solid platform for risk identification, corrective actions, and management re-planning as may be required over the life of a project or program. The course emphasis is on the latest EVM principles and concepts in accordance with changes and guidelines for Earned Value Management in The Guide to the Project Management Body of Knowledge (PMBOK® Guide) and The Practice Standard for Earned Value Management published by the Project Management Institute. What you Will Learn You'll learn how to: Develop a project baseline, using an effective WBS Record actual project performance Calculate EVM measures Evaluate project performance based on EVM measures Respond to project variances Integrate EVM and risk management Determine how EVM will add value to your organization Develop an EVM implementation plan for your organization Getting Started Introductions Course structure Course goals and objectives Expectations Foundation Concepts Introduction to Earned Value Management (EVM) Benefits of EVM EVM Process Overview Applications of EVM Creating a Work Breakdown Structure Reviewing WBS concepts Reviewing WBS development process (decomposition) Using a WBS to support EVM Building a Project Baseline Defining a project baseline Developing a project baseline Using a project baseline Recording Actuals Recording actuals overview Collecting data for actual project performance Determining earned value - various methods EVM Performance Measures Using current status measures Using forecasting measures Analyzing EVM measures EVM and Risk Management Integrating EVM and Risk Management Using EVM measures in the risk register Exploring how EVM can facilitate reserves management Drawing down contingency reserves Responding to Variances Introduction to variances Process for responding to variances Response options Reporting Project Performance EVM reporting overview Meeting EVM reporting needs Addressing EVM reporting challenges Implementing an EVMS Defining EVMS requirements EVM for Agile projects Tailoring the EVMS Summary and Next Steps Review of content Review of objectives / expectations Personal action plan

Project Leadership Skills: Virtual In-House Training To be effective within an organization, project managers need to have a wide variety of skills and abilities. Included among these are: creating and executing on a vision; motivating others; influencing without authority; networking; communicating up, down and laterally; negotiating; managing stakeholders; and managing conflict. This highly interactive workshop focuses on building the soft skills that are critical to leading a team and creating sustainable business change. Participants will gain insight into the social science as well as the brain science behind motivating and empowering others. They will learn and experiment with a variety of influencing strategies and tactics. Working in pairs as well as small groups, they will collaborate with others to brainstorm, share experiences, and apply concepts to everyday challenges. Participants will also discover their personal communication preferences, strengths, and blind spots and will gain insight into how best to communicate with others they find 'difficult.' They will gain insight into managing the people side of change, learning strategies for dealing with each step in the process. Hands-on negotiation and conflict management activities enhance the theoretical learning, grounding it in real life and making it actionable. Interweaving role play with experiential learning and group activities, this course will help participants refine a skill set that is invaluable to their organization, and one that transfers easily across their professional and personal lives. What You Will Learn At the end of this course, you will be able to: Explain the importance of vision in driving motivation and engagement Apply science-based research to better motivate those around you Strategically leverage both personal and positional power to achieve positive project results Determine influencing and networking strategies needed for personal growth Identify ways to problem solve communication challenges when others have different personality styles Connect stakeholder expectations to project success criteria Assess key stakeholders across various dimensions of complexity Apply the four rules of principled negotiation to a real-life conflict situation Recognize key aspects of a physiological response to conflict Utilize selected tools and techniques to 'defuse' an emotional situation Leverage various strategies and tactics to successfully deal with ambiguity at work Getting Started / Foundation Concepts Introductions Course structure, goals, and objectives Beginning a personal action plan Managing Vision and Purpose / Motivating Others Communicating and aligning around vision Tying the present to the future The importance of purpose The art and science of motivation Networking and Influencing Positive politics and project success Types of power within organizations Power and influence Networking best practices Communication The medium and the message Personality and communication styles Communication challenges Stakeholder Management and Negotiation Identifying stakeholders Analyzing stakeholders Negotiation basics Principled negotiation Conflict Management Dynamics of conflict The anatomy of conflict Conflict management approaches and tools Dealing with ambiguity Summary and Next Steps Key concepts review Creating your personal action plan

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.)

Strategic Thinking: Virtual In-House Training 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 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.)

Implementing Scrum for Teams: Virtual In-House Training Scrum is an iterative, incremental framework for developing products. It allows the team to deliver a potentially shippable set of functionalities for each iteration, providing the agility needed to respond to rapidly changing requirements. These characteristics have led to Scrum becoming the most popular method in the world of Agile projects. This two-day course provides a practical approach to implementing the Scrum method on your projects. You will learn how to initiate a Scrum project, how to build a Product Backlog, containing user stories, and how to plan and estimate releases and iterations. You will learn how to conduct Scrum events, such as the Sprint Planning Meeting, and how to track progress during an iteration. You will apply what you learn in a series of hands-on, team-based activities and simulations that take you through the entire Scrum process. The overall goal of the course is to enable you to successfully apply the Scrum method on appropriate projects in your environment. What you will Learn At the end of this program, you will be able to: Teach-back Agile and Scrum foundation concepts Initiate a Scrum Project Conduct Team Sprint Planning and Sprint Review meetings Develop Release Plans (including effective user stories and priorities) Build a Sprint plan (including effective estimates) Executive a Sprint (including essential Scrum ceremonies) Implement Scrum in your environment Foundation Concepts Agile Mindset, Values, and Tenets Agile Benefits and Methods Scrum Overview Teams: Self-Managing, Self-Organizing, and Self-Improving Initiating a Scrum Project 'Sprint Zero' Activities Defining the Vision The Product Backlog and User Stories Acceptance Criteria Story Map Planning Releases Planning releases Estimating user stories Prioritizing user stories Selecting a Sprint length Estimating velocity Creating a release plan Planning a Sprint The Sprint Planning Meeting Building the Sprint Backlog Creating a Sprint Plan Running a Sprint Conduct a Sprint Burn-down and Burn-up Charts Negotiating Changes During a Sprint The Sprint Review Meeting Sprint Retrospective Releasing into Production Closing the Scrum Project Implementing Scrum Scrum Simulation Exercise Conditions of Success for Implementing Scrum