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
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Recovering Troubled Projects: In-House Training Despite our best intentions, many of the projects that organizations undertake either don't achieve their intended business results or end in complete failure. Most seasoned project managers have had their share of experiences with difficult or troubled projects and unless they are careful, they will encounter more. This workshop does not focus on 'failed' projects but rather on those projects which without appropriate intervention would be headed for failure. Failed projects are those beyond help and which should be terminated. Here we focus on projects that are salvageable. It is an exercise-driven, no-nonsense, professional practice-focused workshop positioning the participant to immediately apply the tools and lessons learned in the classroom. The workshop employs the use of both illustrative and practical/working case studies. Illustrative case studies will examine insights from real-world troubled projects. Participants will be asked to bring descriptions of their own examples of troubled projects on which they're currently working or on which they have worked in the past. A number of these will be used as the basis for the practical/working case studies. The approach builds on and complements the disciplines addressed in Project Management Institute's PMBOK® Guide and also addresses issues that arise when managing projects in a complex environment. What You Will Learn You will learn to: Recognize the value of a structured project recovery process Explain the reasons most projects fail Analyze the causes of a project's troubles Construct a negotiation process to use with key stakeholders Apply an effective strategy to planning the recovery effort Manage, evaluate, and adjust the ongoing recovery effort Foundation Concepts Recognizing a troubled project Defining the project recovery process The Reasons Projects Fail Putting failure in perspective Reviewing management issues Analyzing planning issues Exploring complexity issues Assess the Project Stabilizing the project Determining preliminary Go / No-Go Conducting a detailed recovery assessment Negotiate the Recovery Reviewing the basics of negotiation Setting reasonable expectations Obtaining appropriate PM authority Securing key stakeholder support Plan the Recovery Planning for recoveries Rebuilding the project team Reshaping the project plan Managing parallel activities Planning for change management Implement and Adjust the Project Implementing project recoveries Facilitating change Enabling continuous learning Fostering the project team Sustaining stakeholder engagement
Project Management Fundamentals - Chinese: On-Demand The course provides practical skills, concepts and principles that can be brought back to the workplace, as well as the insights needed to adapt them to specific project contexts. Many projects are managed by competent and efficient project managers who have not received professional project management training. The work of these project managers includes optimizing processes, planning marketing, developing new products, event planning and implementation, and other project work. Project Management Fundamentals (PMF) is a project management course specially designed for such people, aiming to help such managers build a solid project management knowledge base without affecting their own work too much. The course covers practical skills, theoretical foundations, working principles required in real work situations, and how to flexibly apply the acquired knowledge to special project situations. The goal of this lesson is to improve the quality of work by learning how to plan, manage and control projects effectively. Based on this, the course will focus on a process-oriented, analytically-oriented and systems-oriented approach. These frameworks will help students improve their problem-solving and decision-making skills in real-world projects, with particular emphasis on the collaborative, effective communication, and interpersonal skills needed to manage projects. These contents will run through the entire PMF course, and will be explained in the following two units: People and Projects Execution , Communication , and Building Project Teams What You Will Learn At the end of the course you will be able to: Describe the value of strong project management Identify the characteristics of successful projects and project managers Recognize how current agile/adaptive practices fit into project management Explore the project management process, including initiating, planning, executing, monitoring and controlling, and closing Use project management processes and tools based on case studies and real-world contexts Create a preliminary project plan Use standard project management terminology Basic Concepts Project Management and Related Definitions The Value and Emphasis of Project Management Competitive Constraints and Project Success project life cycle People and Projects Overview of people and projects project manager project team people and projects in the organization Initiating and Defining Requirements Startup project Create a project charter Conduct stakeholder assessments define requirements Using a Work Breakdown Structure Define the Work Breakdown Structure (WBS) Create a working WBS use WBS Managing Project Risk Rationale for risk management Risk Planning Overview identify risks analyze risk Planning Risk Responses Implement response and monitor risks Adaptive Environmental Considerations Estimate Preparation Define estimates Estimation method Estimation practice estimated cost Verify estimates Scheduling Define the scheduling process and related terminology Sorting and defining dependencies Determine the critical path Consider Schedule Risk vs Optimizing Schedule Execution , Communication , and Building Project Teams From Baseline to Execution Project Communications and Stakeholder Relations efficient team Monitoring and Control Define Monitoring and Control Observing how to control from the perspective of competitive constraints Variance Analysis and Corrective Action (Earned Value) Adaptive Environmental Considerations Closing Project finishing project Focus on Project Transition Focus on post-project evaluation
Project Management Fundamentals - Chinese: On-Demand The course provides practical skills, concepts and principles that can be brought back to the workplace, as well as the insights needed to adapt them to specific project contexts. Many projects are managed by competent and efficient project managers who have not received professional project management training. The work of these project managers includes optimizing processes, planning marketing, developing new products, event planning and implementation, and other project work. Project Management Fundamentals (PMF) is a project management course specially designed for such people, aiming to help such managers build a solid project management knowledge base without affecting their own work too much. The course covers practical skills, theoretical foundations, working principles required in real work situations, and how to flexibly apply the acquired knowledge to special project situations. The goal of this lesson is to improve the quality of work by learning how to plan, manage and control projects effectively. Based on this, the course will focus on a process-oriented, analytically-oriented and systems-oriented approach. These frameworks will help students improve their problem-solving and decision-making skills in real-world projects, with particular emphasis on the collaborative, effective communication, and interpersonal skills needed to manage projects. These contents will run through the entire PMF course, and will be explained in the following two units: People and Projects Execution , Communication , and Building Project Teams What You Will Learn At the end of the course you will be able to: Describe the value of strong project management Identify the characteristics of successful projects and project managers Recognize how current agile/adaptive practices fit into project management Explore the project management process, including initiating, planning, executing, monitoring and controlling, and closing Use project management processes and tools based on case studies and real-world contexts Create a preliminary project plan Use standard project management terminology Basic Concepts Project Management and Related Definitions The Value and Emphasis of Project Management Competitive Constraints and Project Success project life cycle People and Projects Overview of people and projects project manager project team people and projects in the organization Initiating and Defining Requirements Startup project Create a project charter Conduct stakeholder assessments define requirements Using a Work Breakdown Structure Define the Work Breakdown Structure (WBS) Create a working WBS use WBS Managing Project Risk Rationale for risk management Risk Planning Overview identify risks analyze risk Planning Risk Responses Implement response and monitor risks Adaptive Environmental Considerations Estimate Preparation Define estimates Estimation method Estimation practice estimated cost Verify estimates Scheduling Define the scheduling process and related terminology Sorting and defining dependencies Determine the critical path Consider Schedule Risk vs Optimizing Schedule Execution , Communication , and Building Project Teams From Baseline to Execution Project Communications and Stakeholder Relations efficient team Monitoring and Control Define Monitoring and Control Observing how to control from the perspective of competitive constraints Variance Analysis and Corrective Action (Earned Value) Adaptive Environmental Considerations Closing Project finishing project Focus on Project Transition Focus on post-project evaluation
Motorsport is as much a business as it is a sport. Our new master’s programme will provide students with a broad range of modules which examine the national and international aspects of the industry from a commercial perspective. From governance, structure and international sports law, through to the importance and interdependence of commercial rights holders, promoters, manufacturer, teams, sponsors and the role played by the media, this course is aimed at enhancing the professional and career prospects of those with an aspiration of working within this exciting and challenging global industry. Our programme will help you to develop as professionals with a strong grounding in ethics and a clear sense of how motorsport relates to various cultures, stakeholders and the sectors it interacts with.
About this Virtual Instructor Led Training (VILT) Electrification of the transportation sector will impact the power system in several ways. Besides the additional load, local impact on the grid needs to be managed by the grid operators. Simultaneously charging of many electric vehicles (EVs) might exceed the limits in specific locations. On the other hand, EVs can provide flexibility and other ancillary services that will help grid operators. This 3 half-day VILT course will provide a complete overview of integrating electric vehicles (EVs) into the power grid. It will cover the whole value chain from grid operations to the car battery. This includes the control room, possible grid reinforcement, demand side management and power electronics. This course will demonstrate the impact on the grid and solutions for a safe & cost-effective grid plan and operation, with examples of successful integration of EVs. The course will also provide vital knowledge about technology used for EVs such as power electronics, demand side management, communication and batteries. In this context, the focus will be on power electronics as it has the highest impact on the grid. The grid planning tool, pandapower, is introduced as an open source tool for power system modelling. The set-up of the training course allows for discussion and questions. Questions can be formulated by the participants upfront or during the training. This course is delivered in partnership with Fraunhofer IEE. Training Objectives At the end of this course, the participants will: Understand the charging options for EVs and its impact on the grid and batteries Identify system services for EVs with regards to voltage quality at the point of common coupling Discover what are the 'grid friendly' and grid supporting functions in EVs Uncover the different applications, standards and data researched on EVs Examine the application of a grid planning tool (pandapower) for power system modelling Be able to develop code snippets with pandapower Apply and execute a code example for power system modelling with pandapower Target Audience EV and grid project developers and administrators Power grid operators and planners EPC organisations involved in grid development EV/ battery manufacturers and designers EV transport planners and designers Government regulators and policy makers Training Methods The VILT will be delivered online in 3 half-day sessions comprising 4 hours per day, with 2 x 10 minutes breaks per day, including time for lectures, discussion, quizzes and short interactive exercises. Additionally, some self-study will be requested. Participants are invited but not obliged to bring a short presentation (10 mins max) on a practical problem they encountered in their work. This will then be explained and discussed during the VILT. A short test or quiz will be held at the end of every session/day. Trainer Our first course expert is Head of Department Converters and Electrical Drive Systems at Fraunhofer IEE and Professor for Electromobility and Electrical Infrastructure at Bonn-Rhein-Sieg University of Applied Sciences. He received his engineering degree in automation in 2008 by the THM Technische Hochschule Mittelhessen (FH Giessen-Friedberg). Afterwards he studied power engineering at University of Kassel and received his diploma certificate in 2010. In 2016 he received the Ph.D. (Dr.-Ing.) from the University of Hannover. The title of his dissertation is Optimized multifunctional bi-directional charger for electric vehicles. He has been a researcher at the Fraunhofer IEE in Kassel since 2010 and deals with power converters for electric vehicles, photovoltaics and wind energy. His current research interests include the bidirectional inductive power transfer, battery charger and inverter as well as new power electronic components such as SiC MOSFETs and chokes. Additionally, our key expert is Chairman of the IEEE Joint IAS/PELS/IES German Chapter and a member of the International Scientific Committee of the EPE Association. Our second course expert is deputy head of energy storage department at Fraunhofer IEE. Prior to this he was the Director of Grid Integration department at SMA Solar Technology AG, one of the world's largest manufacturers of PV power converters. Before joining SMA, our course expert was manager of the Front Office System Planning at Amprion GmbH (formerly RWE TSO), one of the four German transmission system operators. He holds a degree of electrical engineering of the University of Kassel, Germany. In 2003 he finished his Ph.D. (Dr.-Ing.) on the topic of wind power forecasting at the 'Institute of Solar Energy Supply Technology' (now Fraunhofer IEE) in Kassel. In 2004 he started his career at RWE TSO with main focus on wind power integration and congestion management. Our course expert is chairman of the IEC SC 8A 'Grid Integration of Large-capacity Renewable Energy (RE) Generation' and has published several papers about grid integration of renewable energy source and forecasting systems on books, magazines, international conferences and workshops. Our third course expert is Research Associate at Fraunhofer IEE. He is actively working on different projects related to the integration of electric vehicle charging into the electric distribution grid. The focus of this work concerns time series based simulations for grid planning and operation in order to investigate the effect of a future rollout of electric vehicles and charging infrastructure on economics e.g. costs for grid reinforcement. He completed his master degree (MSc.) in Business Administration and Engineering: Electrical Power Engineering at RWTH Aachen University, Germany. Our trainers are experts from Fraunhofer Institute for Energy Economics and Energy System Technology (Fraunhofer, IEE), Germany. The Fraunhofer IEE researches for the national and international transformation of energy supply systems POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information about post training coaching support and fees applicable for this. Accreditions And Affliations
Project Quality Management: Virtual In-House Training In today's environment, quality is the responsibility of everyone. Project success is no longer just the fulfillment of a project on schedule, on budget, and within the scope. Today, projects aren't successful unless the customer's needs are met at the highest level of quality at the lowest cost to the organization. Project Managers must know customer needs, and manage to them throughout the project lifecycle, in order to gain acceptance. Project Quality Management provides an interactive, hands-on environment for participants to practice identification of critical quality requirements (quality planning), fulfillment of those requirements through well-designed processes (Quality Assurance), and statistical awareness of technical specifications of project deliverables (Quality Control). What You Will Learn You'll learn how to: Plan for higher quality project deliverables Measure key performance indicators on projects, processes, and products Turn data into useful project information Take action on analyzed data that will drive down non-value-added costs and drive up customer acceptance and satisfaction Reduce defects and waste in current project management processes Foundation Concepts Quality Defined Customer Focus Financial Focus Quality Management Process Management Cost of Quality Planning for Quality Project Manager Role in Planning Voice of the Customer Quality Management Plan Measurement System Accuracy Data Gathering Data Sampling Manage Quality Process Management Process Mapping Process Analysis Value Stream Mapping Standardization Visual Workplace and 5S Error Proofing (Poka-Yoke) Failure Mode and Effect Analysis Control Quality The Concept of Variation Common Cause Special Cause Standard Business Reports Tracking Key Measurements Control Charts Data Analysis Variation Root Cause Analysis Variance Management Designing for Quality
PRINCE2 Agile® Practitioner: In-House Training PRINCE2 Agile® Practitioner is a solution combining the flexibility and responsiveness of Agile with the clearly defined framework of PRINCE2®. PRINCE2 Agile® framework covers a wide range of agile concepts, including SCRUM, Kanban, and Lean Startup. The PRINCE2 Agile® Practitioner certification teaches you to blend structure, governance, and control with agile methods, techniques, and approaches. The strength of PRINCE2® lies in the areas of project direction and project management, whereas Agile has a very strong focus on product delivery. When PRINCE2® and agile are combined, project direction, project management, and project delivery are optimized to create a complete project management solution. PRINCE2 Agile® is an extension module tailored for forward-thinking organizations and individuals already benefiting from PRINCE2®. It provides further guidance on how to apply agile methods to the world's most recognized project management method. The purpose of the Practitioner qualification is to demonstrate that you can apply and tailor PRINCE2 Agile® in a scenario situation. What you will Learn Understand the basic concepts of common agile ways of working Understand the purpose and context for combining PRINCE2® and the agile way of working Able to apply and evaluate the focus areas to a project in an agile context Able to fix and flex the aspects of a project in an agile context Apply the PRINCE2® principles and tailor the themes, processes, and management products to a project in an agile context To learn through the use of theory and practical exercises Prepare for the PRINCE2 Agile® Practitioner exam Benefits Agile methods allow organizations to realize the benefits of products and potentially an earlier return on investment while products are being developed and improved Improved communication through the use of common terminology across PRINCE2® and agile disciplines Develop a clear definition of how agile can govern a project's delivery, while PRINCE2® governs projects as a whole Seamless integration: PRINCE2 Agile® will complementPMBOK® GuideandAPM Body of Knowledge® just as PRINCE2® does currently. It will also be of interest for Program Managers with MSP® who need to understand how projects relate to the delivery mechanism. The most up-to-date and relevant view of Agile project management methodologies, PRINCE2 Agile® references the 'flow-based' working featured in Kanban in addition to other agile concepts not covered in other qualifications Agile Overview & Blending PRINCE2 and Agile Agile overview Blending PRINCE2 and Agile Fix and Flex, Agile and PRINCE2 Processes & Starting a Project Fix and Flex Agile and the PRINCE2 Processes; Starting up a project and Initiating a project Business case theme Change and Organization Themes& Principles Change theme Organization theme Agile and PRINCE2 Principles and the Agilometer Managing Product Delivery and Scrum & Plans and Progress Themes Managing product delivery and Scrum Plans Theme and Progress Theme Quality, Controlling & Managing a Stage and Directing Projects and Contracts Quality Theme Controlling a stage and Frequent Releases Managing a stage boundary Directing a project and contracts Closing a project Tailoring PRINCE2 Productsand Other Practices Tailoring PRINCE2 products and other practices
AgilePM® Practitioner: In-House Training This course offers preparation for the Practitioner-level examination to gain the APMG-International™ / Agile Project Management Practitioner Certification. Agile Project Management (AgilePM) is the result of collaboration between APMG-International and The DSDM Consortium. DSDM (Dynamic Systems Development Method) is the longest-established Agile method, launched in 1995, and is the only Agile method to focus on the management of Agile projects. The method has evolved over the years and the DSDM Agile Project Framework is the latest version of which AgilePM is a subset. DSDM has always operated predominantly in the corporate environment and has consistently demonstrated its ability to successfully work with and complement existing corporate processes. APMG-International is a global Examination Institute accredited by The APM Group Ltd. It is one of the Examination Institutes accredited by AXELOS. APMG-International has regional offices located in Australia, China, Denmark, Germany, the Netherlands, Malaysia, the United States, and the United Kingdom. Their portfolio of qualifications includes the Best Practice qualifications of ITIL®, PRINCE2®, MSP®, M_o_R®, and P3O®. AgilePM is one of their specialist management qualifications, which also include Change Management and Service Catalogue. The course covers all the Practitioner elements of the AgilePM Handbook v2 with: Clear explanations of the method and practical examples provided by your course tutor Sample exam paper for the Practitioner-level exams to enrich your knowledge and understanding A case study to allow you to practice the application of the method to an agile project The Traditional Classroom option includes the Practitioner exam to provide you with the right opportunity to verify your new skill set by way of a professional qualification The Virtual Classroom option includes a Practitioner exam voucher to allow you to choose the date and time of your online exam to verify your new skill set by way of a professional qualification What You Will Learn You will learn how to: Identify and apply the concepts, tools, and techniques described in Section 2 (Digging Deeper) of the APMG-International's Agile Project Management Handbook (v2.0) to agile projects Tailor and customize AgilePM to suit the needs of different projects Use AgilePM in conjunction with other project management methods such as PRINCE2® Prepare yourself for the Practitioner exam in AgilePM Roles and Responsibilities - The PM View The roles Key project manager relationships Agile Project Management - Through the Lifecycle The DSDM process and the project lifecycle Project management focus phase by phase The Effective Use of Products The products Deliver on Time - Combining MoSCoW & Timeboxing Ensuring effective prioritisation Bringing MoSCoW and timeboxing together People, Teams, and Interactions Effective communication Collaboration Requirements and User Stories What is a requirement? User stories Estimating - How and When Coping with uncertainty Estimating through the lifecycle Project Planning through the Lifecycle Planning in a DSDM project Planning activities phase by phase Quality - Never Compromise Quality What do we mean by quality? Solution and process quality Risk Management Project risk How DSDM helps mitigate project risk Tailoring the Approach The project approach questionnaire Summary and Next Steps