During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices. After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and gain the "Certified ISO 13485 Lead Implementer' Certificate. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization. About This Course Learning Objectives Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS Learn how to interpret the ISO 13485 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices Course Agenda Day 1: Introduction to ISO 13485 and initiation of a MDQMS Day 2: Plan the implementation of a MDQMS Day 3: Implementation of a MDQMS Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit, and the final exam. Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles. What's Included? Certification fees are included on the exam price Training material containing over 450 pages of information and practical examples will be distributed An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. In case of exam failure, you can retake the exam within 12 months for free Who Should Attend? Managers or consultants involved in Medical Devices Quality Management Expert advisors seeking to master the implementation of a Medical Devices Quality Management System Individuals responsible for maintaining conformance with MDQMS requirements MDQMS team members Accreditation Provided by This course is Accredited by NACS and Administered by the IECB
During this training course, delegates will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process. Based on practical exercises, you will learn audit techniques and become competent to manage an audit program, audit team, communication with customers, and understand reporting requirements. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 13485 Lead Auditor' Certificate. By holding this Certificate, delegates can demonstrate that they have the competencies to audit organizations based on best practices. About This Course Learning Outcomes Review a Medical Devices Quality Management System based on ISO 13485 Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand an auditor's role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011 Learn how to lead an audit and audit team Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011 Course Agenda Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485 Day 2: Audit principles, preparation and launching of an audit Day 3: On-site audit activities Day 4: Closing the audit and final exam. Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final essay style exam, consisting of 12 questions, on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites An understanding of ISO 13485 requirements and knowledge of audit principles. What's Included? Certification fees are included on the exam price Training material containing over 500 pages of information and practical examples will be distributed An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend? Auditors seeking to perform Medical Devices Quality Management System (MDQMS) certification audits Managers or consultants seeking to understand the Medical Devices Quality Management System audit requirements Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements Accreditation Provided by This course is Accredited by NACS and Administered by the IECB
Many organizations seek competent auditors to determine whether their policies, procedures, and controls adhere to ISO 37301 requirements. This training course aims to help you complete these tasks successfully and intends to reflect the importance of effective CMS audits. In addition, this training course aims to strengthen your knowledge and skills to plan and carry out CMS audits based on the guidelines for auditing management systems provided in ISO 19011 and the certification process described in ISO/IEC 17021-1. This training course can potentially qualify you to conduct audits on behalf of conformity assessment bodies. The exercises, quizzes, and case studies provided in this training course are designed to help you practice the most important aspects of a CMS audit: ISO 37301 requirements, auditing principles, tools and techniques used to obtain evidence, leading a team of auditors, conducting interviews with auditee, reviewing documented information, drafting nonconformity reports, and preparing the final audit report. After successfully completing the training course, you can sit for the exam and gain the "Certified ISO 37301 Lead Auditor' credential. This credential validates your professional capabilities and demonstrates that you have the knowledge and skills to audit a CMS based on ISO 37301. About This Course This training course enables you to: Understand the main concepts of a compliance management system (CMS) and its processes based on ISO 37301 Acknowledge the relationship between ISO 37301 and other standards and regulatory frameworks Understand the auditor's role in planning, leading, and following up on a CMS audit in accordance with ISO 19011 Interpret the requirements of ISO 37301 in the context of a CMS audit Plan an audit, lead a team of auditors, draft nonconformity reports, and follow up on an audit Act with due professional care during an audit Course Agenda Day 1: Introduction to the compliance management system (CMS) and ISO 37301 Day 2: Audit principles and the preparation for and initiation of an audit Day 3: On-site audit activities Day 4: Closing of the audit and the Exam. Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites A fundamental understanding of ISO 37301 requirements (or ISO 19600 guidelines) for a CMS and a comprehensive knowledge of audit principles. What's Included? Certification fees are included in the exam price. Training material of over 450 pages of information and practical examples. An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course. In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date. Who Should Attend? The ISO 37301 Lead Auditor training course is intended for: Auditors seeking to perform and lead CMS audits Managers or consultants seeking to master the CMS audit process Individuals responsible for maintaining conformity to ISO 37301 requirements in an organization Technical experts seeking to prepare for a CMS audit Expert advisors and compliance officers Accreditation Provided by This course is Accredited by NACS and Administered by the IECB.
A CMS provides organizations a structured approach to meet all compliance obligations, i.e., requirements that they mandatorily have to comply with such as laws, regulations, court rulings, permits, licenses, as well as those that they voluntarily choose to comply with such as internal policies and procedures, codes of conduct, standards, and agreements with communities or NGOs. About This Course The benefits of implementing a compliance management system (CMS) based on ISO 37301 are manifold: helping the organization avoid or mitigate the costs, risks, and damage of noncompliance, ensuring the long-term sustainability of the organization, promoting trust and confidence, encouraging good governance practices, due diligence, and ethically sound business dealings, etc. The ISO 37301 Lead Implementer training course provides the knowledge needed to establish, implement, manage, maintain, and continually improve a CMS. It aims to provide an in-depth understanding of ISO 37301 requirements, as well as the best practices and approaches used for the implementation and subsequent maintenance of the compliance management system. The training course enables you to help organizations establish processes needed to adhere to all compliance obligations and establish controls that proactively prevent noncompliance and contribute to the creation of a culture of integrity, transparency, and openness. The training course is followed by the certification exam. If you pass, you gain the 'Certified ISO 37301 Lead Implementer' credential. This credential validates your professional capabilities and competences to implement a CMS in an organization based on the requirements of ISO 37301. This training course will help you: Gain a comprehensive understanding of the concepts, approaches, methods, and techniques used for the implementation and effective management of a CMS Acknowledge the correlation between ISO 37301 and other standards and regulatory frameworks Gain the ability to interpret the requirements of ISO 37301 in the specific context of an organization Develop the necessary knowledge and expertise to support an organization in effectively planning, implementing, managing, monitoring, and maintaining a CMS Acquire the expertise to advise an organization in implementing CMS best practices Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites The main requirements for participating in this training course are a basic knowledge of ISO management system standards, as well as a general understanding of ISO 37301 (or ISO 19600 guidelines) and the MS implementation principles. What's Included? Certification fees are included in the exam price. Training material of over 450 pages of information and practical examples will be provided. An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course. In case of exam failure, candidates can retake the exam once for free within 12 months following the initial exam date. Who Should Attend? Managers, consultants, and compliance officers wishing to develop a thorough understanding of ISO 37301 requirements for a compliance management system Managers and consultants seeking a comprehensive CMS implementation framework Compliance officers responsible for practicing due diligence with regard to compliance risks Individuals wishing to contribute in maintaining organizational integrity by supporting ethical behaviour Managers and members of governance, risk management, and compliance teams Individuals aspiring to become compliance officers or compliance management consultant Accreditation Provided by This course is Accredited by NACS and Administered by the IECB
During this training course, you will gain a comprehensive knowledge of a process model for designing and developing an organizational incident management plan. The compatibility of this training course with ISO/IEC 27035 also supports the ISO/IEC 27001 by providing guidance for Information Security Incident Management. After mastering all the necessary concepts of Information Security Incident Management, you can sit for the exam and gain "Certified ISO 27035 Lead Incident Manager" Certification. By holding this certification, you will be able to demonstrate that you have the practical knowledge and professional capabilities to support and lead a team in managing Information Security Incidents. About This Course Learning objectives Master the concepts, approaches, methods, tools and techniques that enable an effective Information Security Incident Management according to ISO/IEC 27035 Acknowledge the correlation between ISO/IEC 27035 and other standards and regulatory frameworks Acquire the expertise to support an organization to effectively implement, manage and maintain an Information Security Incident Response plan Acquire the competence to effectively advise organizations on the best practices of Information Security Incident Management Understand the importance of establishing well-structured procedures and policies for Incident Management processes Develop the expertise to manage an effective Incident Response Team Course Agenda Day 1: Introduction to Information Security Incident Management concepts as recommended by ISO/IEC 27035 Day 2: Designing and preparing an Information Security Incident Management plan Day 3: Enacting the Incident Management process and handling Information Security incidents Day 4: Monitoring and continual improvement of the Information Security Incident Management plan and the Exam. Additional Information Certification fees are included in the exam price. An attendance record worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. In case candidates fail the exam, they can retake it within 12 months of the initial attempt for free. Accreditation Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Our Guarantee We are an Accredited Training Provider of the IECB. You can learn wherever and whenever you want with our robust classroom and interactive online training courses. Our courses are taught by qualified practitioners with a minimum of 25 years commercial experience. We strive to give our delegates the hands-on experience. Our courses are all-inclusive with no hidden extras. The one-off cost covers the training, all course materials, and exam voucher. Our aim: To achieve a 100% first time pass rate on all our instructor-led courses. Our Promise: Pass first time or 'train' again for FREE. *FREE training offered for retakes - come back within a year and only pay for the exam. Prerequisites A fundamental understanding of ISO/IEC 27035 and comprehensive knowledge of Information Security. What's Included? Delegates will be provided with; Course Slide deck Questions and Answers Bank Participant Guide Who Should Attend? Information Security Incident managers IT Managers IT Auditors Managers seeking to establish an Incident Response Team (IRT) Managers seeking to learn more about operating effective IRTs Information Security risk managers IT system administration professionals IT network administration professionals Members of Incident Response Teams Individuals responsible for Information Security within an organization Provided by This course is Accredited by NACS and Administered by the IECB
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Microsoft Project Blue Belt® 2016: Virtual In-House Training This course introduces Project Server 2016 features that expedite scheduling projects and simplify managing tasks within an enterprise environment. Learn different aspects of Project Server and their benefits to varying roles in the enterprise, and gain hands-on experience and insights on best practices from SMEs around the world. This course introduces Project Server 2016 features that expedite scheduling projects and simplify managing tasks within an enterprise environment. Learn different aspects of Project Server and their benefits to varying roles in the enterprise, and gain hands-on experience and insights on best practices from SMEs around the world. Users in Project online will get the same benefits of this program. What you Will Learn You'll learn how to: Describe the Enterprise Project Management (EPM) environment Apply the basic project management principles of, initiating, planning, executing, monitoring and controlling, and closing your project schedules Discuss new features Explain PWA views project sites Meet deadlines and budget restrictions Keep the workloads of your resources within their available limits Explain tracking methods and manage task assignments Update the schedule Differentiate between updating tasks and timesheets Use standard reports, custom views, and visual reports for your projects Recognize the potential of the Business Intelligence features Getting Started with Microsoft® Project Server 2016 Describing the EPM context Discovering Project Web App Differentiating the users of PWA Working with Project Professional and PWA Initiating Projects New projects with Project Professional, SharePoint lists, Enterprise Projects Importing schedules and managing project owner and permissions Customize the ribbon with enterprise commands Planning Projects - Scope and Schedule Management Scheduling in PWA Using the Deliverables feature Developing components of the risk management plan and issues tracking Linking planning documents Planning Projects - Staffing Management Plan Building a project team Managing resource availability Reviewing the assignment cycle Managing resource engagements Resolving resource overallocation Executing, Monitoring and Controlling Baselines Working with timesheets Reporting administrative time Tracking methods (% work, actual work, single entry mode) Assignment progress and updates in PWA Task progress and updates in Project Professional and PWA Monitor and Control Projects - Measuring Performance and Reporting Progress Reviewing performance metrics and progress reports Using the preloaded reports at the Business Intelligence Center Considerations for defining custom reports Closing Projects Reviewing the closing processes and closing tasks to updates Supporting the closing process
Microsoft Project Blue Belt® 2016: In-House Training This course introduces Project Server 2016 features that expedite scheduling projects and simplify managing tasks within an enterprise environment. Learn different aspects of Project Server and their benefits to varying roles in the enterprise, and gain hands-on experience and insights on best practices from SMEs around the world. This course introduces Project Server 2016 features that expedite scheduling projects and simplify managing tasks within an enterprise environment. Learn different aspects of Project Server and their benefits to varying roles in the enterprise, and gain hands-on experience and insights on best practices from SMEs around the world. Users in Project online will get the same benefits of this program. What you Will Learn You'll learn how to: Describe the Enterprise Project Management (EPM) environment Apply the basic project management principles of, initiating, planning, executing, monitoring and controlling, and closing your project schedules Discuss new features Explain PWA views project sites Meet deadlines and budget restrictions Keep the workloads of your resources within their available limits Explain tracking methods and manage task assignments Update the schedule Differentiate between updating tasks and timesheets Use standard reports, custom views, and visual reports for your projects Recognize the potential of the Business Intelligence features Getting Started with Microsoft® Project Server 2016 Describing the EPM context Discovering Project Web App Differentiating the users of PWA Working with Project Professional and PWA Initiating Projects New projects with Project Professional, SharePoint lists, Enterprise Projects Importing schedules and managing project owner and permissions Customize the ribbon with enterprise commands Planning Projects - Scope and Schedule Management Scheduling in PWA Using the Deliverables feature Developing components of the risk management plan and issues tracking Linking planning documents Planning Projects - Staffing Management Plan Building a project team Managing resource availability Reviewing the assignment cycle Managing resource engagements Resolving resource overallocation Executing, Monitoring and Controlling Baselines Working with timesheets Reporting administrative time Tracking methods (% work, actual work, single entry mode) Assignment progress and updates in PWA Task progress and updates in Project Professional and PWA Monitor and Control Projects - Measuring Performance and Reporting Progress Reviewing performance metrics and progress reports Using the preloaded reports at the Business Intelligence Center Considerations for defining custom reports Closing Projects Reviewing the closing processes and closing tasks to updates Supporting the closing process
Managing Multiple Projects: 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?
Global Project Management: In-House Training: In-House Training In this course, you will dig deeper-and differently-into project management processes, tools, and techniques, developing the ability to see them through the lens of global and cultural project impacts. In today's increasingly global environment, managing a project with customers and support organizations spread across multiple countries and continents is a major challenge. From identifying stakeholders and gathering requirements, to planning, controlling, and executing the project, the basic logistics of a global project present their own standard challenges. However, with additional cultural, language-based, and regional elements, global projects involve more complexities than teams often realize. There are unique communication needs, cultural awareness elements, varying customs and work expectations, and critical legal differences to consider. In this course, you will dig deeper-and differently-into project management processes, tools, and techniques, developing the ability to see them through the lens of global and cultural project impacts. This will leverage you to problem solve differently on global projects, prevent problems, and ensure success. The goal is for you to effectively navigate the challenges of leading projects with multi-regional footprints and globally diverse sets of stakeholders. What you Will Learn At the end of this program, you will be able to: Determine when a project meets the criteria of being a true global one Articulate global project needs based on the project grid and framework Identify and analyze global project stakeholders Recognize cultural differences and articulate how they impact project work Determine global project estimating, scheduling, and staffing challenges Assess global project risks and develop problem-solving responses Analyze complex cultural situations and align optimal project communication and negotiation tools and techniques Apply best practices for conducting virtual team work and mitigating virtual challenges Evaluate ways to control for global project scope, cost, and procurement Align customer management best practices with global customer needs Implement key global project closing activities Foundation Concepts What is a global project? What makes a global project different? A global project management framework Initiating the Global Project Launching a global project Respecting cultural differences Identifying and analyzing stakeholders Developing the communications plan Defining the ideal global project manager Crafting a global project charter Planning the Global Project Gathering requirements for a global project Defining the scope, region by region Estimating and scheduling for global projects Staffing the global project Developing the global risk management plan Executing the Global Project Managing global stakeholder expectations Embracing cultural diversity Honing global negotiation techniques Procuring goods and services on a global basis Managing global legal and regulatory issues at the micro and macro level Monitoring and Controlling the Global Project Status reporting Virtual communication Cost control Schedule control Scope control Customer satisfaction Closing the Global Project Contract closure at the macro and micro levels Administrative closure with global reach Lessons learned