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
Applied Strategic Healthcare Leadership Course An ACHE-Accredited Executive Program | $1,200 USD Sharpen Your Strategic and Financial Leadership in Healthcare This highly interactive program is designed exclusively for executives and fellows of the American College of Healthcare Executives (ACHE) who are ready to elevate their strategic and financial decision-making capabilities through immersive simulation-based learning. Delivered over a series of six engaging Zoom sessions, the Applied Strategic Healthcare Leadership Course equips you with critical tools to drive performance in your healthcare organization while earning 12 ACHE continuing professional education credits. What Makes This Course Unique? Simulation-Based Learning: Leverage the industry-leading Healthcare Hero hospital management simulation, used in top-tier MHA and MBA programs globally. Team-Based Executive Challenge: Work in teams to manage a virtual hospital, facing real-world challenges and dynamic market forces. Experiential Learning: Make executive-level decisions across strategy, operations, and finance in a safe, competitive environment that mirrors the complexities of modern healthcare. Facilitated by Experts: Guided by experienced healthcare and simulation facilitators with deep knowledge of executive leadership and health system strategy. Course Format 6 x 2-hour Zoom sessions (12 contact hours total) The zoom sessions will run weekly from Saturday 11am-1pm Eastern, starting on April 5th Combines strategic and financial management lectures with 8 intensive simulation rounds Practice rounds to build confidence, followed by a competitive live game Final session includes a powerful executive debrief to help you apply insights directly to your organization Key Learning Outcomes By completing this program, you will: ✔ Apply advanced strategy frameworks tailored to healthcare ✔ Strengthen your financial leadership with healthcare-specific KPIs and analysis ✔ Improve team-based executive decision-making under real-world pressure ✔ Learn how to balance mission, margin, and market dynamics ✔ Take home actionable insights to drive performance improvement in your role Who Should Enroll This course is ideal for: ACHE members and fellows seeking executive-level simulation training Healthcare executives responsible for strategy, operations, or finance MHA/MBA graduates looking to sharpen applied skills Leaders preparing for expanded organizational responsibility Program Fee 💲 $1,200 USD (Includes full simulation access, live facilitation, team coaching, and all course materials.) Enroll Now About the Simulation Healthcare Hero is a highly acclaimed hospital management simulation designed to challenge participants with the real-world complexities of running a competitive healthcare system. Trusted by leading universities and executive education programs worldwide. Frequently Asked Questions 1. Who is this course designed for? This program is specifically designed for healthcare executives, ACHE members, and fellows who wish to enhance their strategic, financial, and leadership capabilities through applied learning. It’s also ideal for senior managers preparing for executive roles. 2. How does the Healthcare Hero simulation work? Healthcare Hero is an interactive, web-based hospital management simulation. Working in teams, you will make key decisions across hospital strategy, operations, and finance, while competing against other teams in a dynamic, simulated healthcare market. No prior simulation experience is required—full guidance will be provided. 3. How much time will I need to commit? The program consists of 6 x 2-hour Zoom sessions (12 hours total), spread over several weeks. Between sessions, you may wish to review materials or discuss strategies with your team, but no additional time commitment is required. 4. What topics will be covered? You will explore critical areas such as healthcare strategy, financial management, team leadership, and decision-making under pressure. The course blends applied simulation rounds with lectures on strategic management and financial leadership in healthcare. 5. Will I earn ACHE continuing professional education (CPE) credits? Yes, this program is eligible for 12 ACHE-approved CPE credits, contributing toward your ongoing professional development. 6. Do I need prior experience with simulations? No simulation experience is needed. The first sessions include practice rounds and onboarding to help you get comfortable with the platform and decision-making process. 7. How will teams be formed? Participants will be assigned to teams during the first session to encourage collaboration, peer learning, and networking. Team performance will be key to success in the simulation. 8. What’s included in the course fee? Your $1,200 USD fee includes access to the Healthcare Hero simulation, live facilitation, course materials, team coaching, and participation in all Zoom sessions. 9. Is there a certificate of completion? Yes, participants will receive a certificate of completion after finishing the course and simulation rounds. This can be used to demonstrate CPE credits to ACHE. 10. Can I cancel or transfer my registration? Cancellations are allowed up to 14 days before the course start date for a full refund. Transfers to a future cohort are available subject to availability. Please contact us directly to process cancellations or transfers.
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Business Analysis Fundamentals: Virtual In-House Training This course is part of IIL's Business Analysis Certificate Program (BACP), a program designed to help prepare individuals to pass the IIBA® Certification exam to become a Certified Business Analysis Professional (CBAP™). This course teaches participants the overall process of business analysis and where it fits in the bigger picture of the project life cycle and the business context. The course is interactive and combines discussion, active workshops, and demonstrations of techniques. The goal is bottom-line results that cut through the real-world problems facing people seeking to improve the way they operate to develop new and improved systems and products or otherwise deliver results through project performance. What you will Learn At the end of this program, you will be able to: Define the solution scope Work with the development team in the systems testing stage Ensure the solution is usable in the business environment Foundation Concepts Defining the business analyst (BA) function The role of the BA as change agent An introduction to the BABOK® Guide BA roles and relationships through the project life cycle (PLC) Business Analysis Planning and Monitoring Overview of business analysis planning and monitoring (BAP&M) Business analysis planning and monitoring - process and tools Business analysis planning and monitoring - roles and responsibilities Business analysis planning and monitoring - governance, information management, and performance improvement Elicitation and Collaboration Overview of elicitation and collaboration Elicitation and collaboration techniques Requirements Life Cycle Management Overview of requirements life cycle management Requirements life cycle management task details Strategy Analysis Overview of strategy analysis Analyze current state Define future state Assess risks Define change strategy Requirements Analysis and Design Definition Overview of requirements analysis and design definition (RA&DD) The anatomy of requirements RA&DD task descriptions RA&DD techniques Solution Evaluation Overview of solution evaluation Solution evaluation tasks Solution evaluation in development stages Underlying Competencies Overview of underlying competencies (UC) Underlying competencies
Assuring Quality Through Acceptance Testing: Virtual In-House Training It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. It is the business analyst's job to define the business problem to be solved by IT. It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. The business analyst is not only concerned with the testing itself, but also with the management and monitoring of the users doing the acceptance testing, and recording, analyzing, and evaluating the results. What you will Learn Upon completion, participants will be able to: Create a set of acceptance test cases Manage and monitor an acceptance test stage where users perform the testing Work with the development team in the systems testing stage Assess the solution once it is in the business environment Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide BA roles and relationships through the project life cycle Introduction to assuring software quality through acceptance testing The Scope of IT Testing Overview of testing stages The testing process Testing documentation Pre-Acceptance Testing The BA's role in testing Early development testing stages (unit and integration) Late development testing stage (system) The Acceptance Test Stage - Part I (Planning, Design, and Development) Overview of user acceptance testing Acceptance test planning Designing user acceptance tests Developing individual user acceptance test cases Building effective user acceptance test scenarios The Acceptance Test Stage - Part II (Execution and Reporting) Operating guidelines Execution Reporting Post-Acceptance Testing Overview Project implementation Project transition (project closure) Production through retirement Testing Commercial Off-the-Shelf (COTS) Software Overview Selecting the software Implementing the software Summary What did we learn and how can we implement this in our work environments?
Project Risk Management: Virtual In-House Training Have you been surprised by unplanned events during your projects? Are you and your project team frequently fighting fires? Well, you are not alone. Uncertainty exists in any project environment. While it's impossible to predict project outcomes with 100% certainty, you can influence the outcome, avoid potential risks, and be ready to respond to challenges that arise. In this course, you'll gain the proper knowledge needed to identify, assess, plan for, and monitor risk in your projects. You'll learn how to set up and implement risk management processes, helping you to minimize uncertainty and achieve more consistent, predictable outcomes as a result. What You Will Learn You'll learn how to: Demonstrate to others how the risk management processes in A Guide to the Project Management Body of Knowledge (PMBOK® Guide) apply to your project's environment, especially for high-risk projects Adapt these processes for a particular high-risk project team's operating principles Explain the importance of using risk management best practices at single and enterprise project levels Lead an initiative to implement risk management best practices in your project environment Foundation Concepts Risk-related definitions The risk management process High-risk projects and project failures Classical failures in implementing risk management Plan Risk Management Project risk management and governance Risk management planning for high-risk projects High-risk variations on a risk management plan Identify Risk Adapting the risk identification process for high-risk projects Recognizing risks spontaneously Confirming and structuring risk events for treatment Wrapping up risk identification for high-risk projects Perform Qualitative Risk Analysis Adapting qualitative risk analysis for high-risk projects Accelerating risk analysis Clearing risk action Wrapping up qualitative risk analysis for the next level Perform Quantitative Risk Analysis Adapting quantitative risk analysis for high-risk projects Ensuring effective risk analyses with data quality assessments Building a foundation for quantitative risk analysis Using discrete quantitative tools Using continuous quantitative tools Wrapping up quantitative risk analysis for high-risk projects Plan Risk Responses Adapting risk response planning for high-risk projects Optimizing active risk response strategies Leveraging contingencies for high project performance Wrapping up risk response planning for high-risk projects Implement Risk Responses Implementing Risk Responses Process Executing Risk Response Plans Tools and Techniques Best Practices Continuous Risk Management Monitor Risks Adapting risk monitoring for high-risk projects Optimizing risk plan maintenance Weaving risk reassessment into the project's progress Maintaining a continuous 'vigil' in high-risk project environments
Business Intelligence: Virtual In-House Training Business Intelligence (BI) refers to a set of technology-based techniques, applications, and practices used to aggregate, analyze, and present business data. BI practices provide historical and current views of vast amounts of data and generate predictions for business operations. The purpose of Business Intelligence is the support of better business decision making. This course provides an overview of the technology and application of BI and how it can be used to improve corporate performance. What you will Learn You will learn how to: Specify a data warehouse schema Identify the data and visualization to be used for data mining and Business Intelligence Design a Business Intelligence user interface Getting Started Introductions Agenda Expectations Foundation Concepts The challenge of decision making What is Business Intelligence? The Business Intelligence value proposition Business Intelligence taxonomy Business Intelligence management issues Sources of Business Intelligence Data warehousing Data and information Information architecture Defining the data warehouse and its relationships Facts and dimensions Modeling, meta-modeling, and schemas Alternate architectures Building the data warehouse Extracting Transforming Loading Setting up the data and relationships Dimensions and the Fact Table Implementing many-to-many relationships in data warehouse Data marts Online Analytical Processing (OLAP) What is OLAP? OLAP and OLTP OLAP functionality Multi-dimensions Thinking in more than two dimensions What are the possibilities? OLAP architecture Cubism Tools OLAP variations - MOLAP, ROLAP, HOLAP BI using SOA Applications of Business Intelligence Applying BI through OLAP Enterprise Resource Planning and CRM Business Intelligence and financial information Business Intelligence User Interfaces and Presentations Data access Push-pull data access Types of decision support systems Designing the front end Presentation formats Dashboards Types of dashboards Common dashboard features Briefing books and scorecards Querying and Reporting Reporting emphasis Retrofitting Talking back Key Performance Indicators Report Definition and Visualization Typical reporting environment Forms of visualization Unconstrained views Data mining What is in the mine? Applications for data mining Data mining architecture Cross Industry Standard Process for Data Mining (CISP-DM) Data mining techniques Validation The Business Intelligence User Experience The business analyst role Business analysis and data analysis Five-step approach Cultural impact Identifying questions Gathering information Understand the goals The strategic Business Intelligence cycle Focus of Business Intelligence Design for the user Iterate the access Iterative solution development process Review and validation questions Basic approaches Building ad-hoc queries Building on-demand self-service reports Closed loop Business Intelligence Coming attractions - future of Business Intelligence Best practices in Business Intelligence