5521 TEC courses

Facilitation Skills Training

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 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 17 Points Development Level Develop

Preparing for Digital Transformation Organizations today must keep pace with changing technology to stay abreast of the market demand. Keeping pace means a transformation of the entire organization into the digital age. This workshop presents the challenges, benefits, and pitfalls of digital transformation and how it will affect you, and how you can be better prepared and positioned for the upcoming digital transformation. The goal of this course is to enable you to become knowledgeable about the technologies behind a digital transformation in your organization and the driving forces compelling such a transformation. You will learn how to become engaged in the processes of transforming your organization digitally to meet with the growing demands of customers and clients What you will Learn Describe the impact that digital is making on the economy and on customer expectations Examine the nature and drivers of the digital transformation Evaluate new technologies such as Blockchain, Big Data, Artificial Intelligence, and other technologies and see how they work to bring about digital transformation Assess the impact of digital technologies on the current roles and positions in the organization Discuss both the demand that customers have for digital technologies and the impact the digital technologies have on the customer and its relationship with the organization Recognize the new technology trends in the digital transformation and what they mean to the future of the organization Identify how digital transformation will affect all roles and how to be prepared for the upcoming and continuing digital transformation Foundation Concepts Digital transformation versus automation Driving forces behind the digital transformation Learning from digital transformation successes Digital Transformation and Customer Orientation The Digital Customer Customer touch points and the customer journey Omnichannel concept Transform to the customer Digital Technologies and the Organization Relationship Management Big Data: The Basis for it All The Human Factor in Digital Transformations Risks of Digital Transformation Technology Trends Data and Business Analytics Other Major Trends Preview of Coming Attractions Pathway to Digital Transformation

Project Estimating and Scheduling Establishing realistic estimates and goals for projects that support business objectives and meet client expectations is one of the most challenging aspects of project planning. Delivering those results within the agreed-upon time, cost, and quality constraints is also challenging. Attempting to meet impossible deadlines with limited budgets often leads to unplanned product shortfalls, causing long-term support and utilization problems. We have all anguished about this recurring problem, but without having the skills or knowledge to take action, we are unable to break the cycle! The goal of this course is for you to be able to support business objectives and meet client expectations by selecting the right planning approach for realistic and cost effective schedules, as well as project budgets. To achieve that, you will focus on gaining the necessary knowledge, skills, and techniques. What You Will Learn At the end of this program, you will be able to: Use the work breakdown structure (WBS) as the basis for effective estimating of project resources Estimate effort and duration using a variety of techniques Develop preliminary schedules using the critical path method Apply a variety of optimization techniques to refine preliminary schedules Establish realistic schedule and cost baselines, with appropriate contingency reserves Explain how earned value management (EVM) contributes to control time and cost performance Foundation Concepts Project management basic definitions and concepts PES Key driver: competing constraints PES Process and success factors Project Definition and the WBS Project definition overview Work Breakdown Structure (WBS) Decomposition: WBS development technique Resource Planning Resource planning overview Identifying resource requirements Identifying and filling resource gaps Applying resource planning tools Effort and Duration Estimating Estimating overview Estimating perspectives and approaches Estimating techniques Effort and duration estimating best practices Project Scheduling Overview of project scheduling Dependencies and the project network diagram Critical path method (CPM) Optimizing the schedule Budget, Risk, and Contingency Planning Overview of budget, risk, and contingency planning Estimating costs Determining the budget Project risk management processes Planning contingency reserves Project Baseline and Control Overview of project baseline Negotiating and the project baseline Earned value management (EVM) Project variances and actions Project control

Mediation for Managers Training

Mediation for Managers Training

Project Requirements Management Poor requirements definition and lack of adequate change control procedures to requirements and scope are the primary contributors to project difficulty and failure. This workshop will provide you with the knowledge, tools, and techniques required to minimize or avoid these pitfalls. What You Will Learn You'll learn how to: Explain the Requirement Management process within the project lifecycle Understand requirements terminology and structure for definition and development Apply and evaluate techniques to identify and draw out requirements from people, places, and things Create models to conceptualize the requirements landscape and communicate effectively with stakeholders Indicate the importance of requirements prioritization Write SMART requirements using structured language skills Understand how to apply checklists, questionnaires, and document templates in the requirements development process Verify and validate requirements to support project success Effectively manage changing requirements across the project lifecycle Requirements Framework Requirements definitions The importance of requirements Type of requirements Developing Requirements: The Process High-level requirements development and management process Stakeholder involvement in requirements management Progressive elaboration in requirements management Elicit Requirements Requirements-Gathering Approach Sources of Information Requirements-Gathering Techniques Analyze Requirements Models and Requirements Using Use Cases Prioritizing Requirements Specify Requirements Specifying Requirements Essential Technical Writing Skills SMART Requirements Quality Attributes Monitor and Control Requirements Why and When Requirements Change Change Management and Control Requirements Traceability Validating and Verifying Requirements Validating Requirements Verifying Requirements Using Checklists

Managing Complex Projects As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environment As knowledge and technology expand exponentially, organizations are finding that the tools, processes, and methods used to select, plan, and manage their projects are insufficient for the challenges posed by them. Complex projects don't necessarily follow the rules of traditional projects - in many instances the projects' end-products, and the methods by which they will be produced, are not easily defined. Stakeholder diversity and geographical dispersion contribute to the difficulties project managers face in their efforts to gain acceptance of project goals, objectives, and changes. Additionally, hierarchic leadership styles, traditional lifecycle approaches, and traditional project manager competencies may no longer maximize the efficiencies that need to be realized on complex projects. The goal of this course is to provide participants with a working knowledge of project complexities and a framework for managing the ambiguities involved in today's fast-changing, competitive, and technology-based environments. What you Will Learn The learning objectives of this workshop are to enable participants to: Appreciate complexity and its impact on the management of projects Describe the differences among traditional, complicated, and complex projects Explain the effects of complexity on the PMBOK® Guide's process groups Apply a high-level model in the management of real- world projects Complexity and Projects Some characteristics of complex systems Important models/characteristics of complex projects Major players in project complexity Landscapes and project typologies A supplemental framework for complex projects Framing Framing overview Potential pitfalls in framing complex projects Possible solutions Inception Centrality of risk management PM competencies, selection Stakeholder identification, analysis Blueprint Collaborative planning Stakeholder engagements Alternative methodologies/life cycles Collaborative scheduling Procurement management Oversight, Navigation, and Adjustment Leadership and the project team Stakeholder management Networks Close and Continuous Improvement Transition/support Post-project evaluations Rewards/Recognition

Global Project Management 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

Business Intelligence 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