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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
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About this Virtual Instructor Led Training (VILT) This Virtual Instructor Led Training (VILT) course presents advanced methodologies that implement demand response and energy conservation programs in light of the integration of new technologies, regulatory changes and the accelerated penetration of renewable energy resources. This VILT course provides examples and case studies from North American and European jurisdictions covering the operational flexibilities on the demand side including requirements for new building codes to achieve zero net energy. The course describes a public agency's goals and objectives for conserving and otherwise reducing energy consumption and managing its demand for energy. This course presents the demand response implemented for economics and system security such as system balancing and relieving transmission congestion, or for system adequacy. The course also presents the principal attributes of conservation programs and the associated success criteria. In a system with increased penetration of renewable resources, demand response provides flexibility to system operators, helping them to maintain the reliability and the security of supply. Demand response is presented as a competitive alternative to additional power sources, enhancing competition and liquidity in electricity markets. The unique characteristics are discussed from a local, consumer centric and also from a system perspective bringing to life the ever changing paradigm for delivery energy to customers. Interoperability aspects and standards are discussed, as well as the consumer centric paradigm of Transactive Energy with IOT enabled flexibilities at system level, distribution networks and microgrids. The VILT course introduces the blockchain as a new line of defense against cyber threats and its increasing application in P2P transactions and renewable certificates. Our trainer's industry experience spans three decades with one of the largest Canadian utilities where she led or contributed to large operational studies and energy policies and decades of work with IEEE, NSERC and CIGRE. Our key expert also approaches to the cross sectional, interdisciplinary state of the art methodologies brings real life experience of recent industry developments. Training Objectives Innovative Digital Technologies How systems Facilitate Operational Flexibility on the Demand Side The Ecosystem of Demand Side Management Programs Advanced Machine Learning techniques with examples from CAISO Regulatory Policy Context and how to reduce regulatory barriers Industry Examples from NERC and ENTSO Relevant Industry standards: IEEE and IEC Manage Congestion with Distributed Operational Flexibilities: Grid to Distribution Controls; examples from NERC (NA) and ENTSO (Europe) Grid solutions with IEC 61850 communication protocols Decentralized grid controls The New Grid with accelerated V2G and Microgrids How DSM is and will be applied in Your System: Examples and discussions Target Audience Regulators and government agencies advising on public energy conservation programs All professionals interested in expanding their expertise, or advancing their career, or take on management and leadership roles in the rapidly evolving energy sector Energy professionals implementing demand side management, particularly in power systems with increased renewable penetration, to allow the much needed operational flexibility paramount to maintaining the reliability and stability of the power system and in the same time offering all classes of customers flexible and economical choices Any utility professional interested in understanding the new developments in the power industry Course Level Basic or Foundation Training Methods The VILT course will be delivered online in 5 half-day sessions comprising 4 hours per day, with 2 x 10 minutes break per day, including time for lectures, discussion, quizzes and short classroom exercises. Course Duration: 5 half-day sessions, 4 hours per session (20 hours in total). Trainer Your first expert course leader is a Utility Executive with extensive global experience in power system operation and planning, energy markets, enterprise risk and regulatory oversight. She consults on energy markets integrating renewable resources from planning to operation. She led complex projects in operations and conducted long term planning studies to support planning and operational reliability standards. Specializing in Smart Grids, Operational flexibilities, Renewable generation, Reliability, Financial Engineering, Energy Markets and Power System Integration, she was recently engaged by the Inter-American Development Bank/MHI in Guyana. She was the Operations Expert in the regulatory assessment in Oman. She is a registered member of the Professional Engineers of Ontario, Canada. She is also a contributing member to the IEEE Standards Association, WG Blockchain P2418.5. With over 25 years with Ontario Power Generation (Revenue $1.2 Billion CAD, I/S 16 GW), she served as Canadian representative in CIGRE, committee member in NSERC (Natural Sciences and Engineering Research Council of Canada), and Senior Member IEEE and Elsevier since the 90ties. Our key expert chaired international conferences, lectured on several continents, published a book on Reliability and Security of Nuclear Power Plants, contributed to IEEE and PMAPS and published in the Ontario Journal for Public Policy, Canada. She delivered seminars organized by the Power Engineering Society, IEEE plus seminars to power companies worldwide, including Oman, Thailand, Saudi Arabia, Malaysia, Indonesia, Portugal, South Africa, Japan, Romania, and Guyana. Your second expert course leader is the co-founder and Director of Research at Xesto Inc. Xesto is a spatial computing AI startup based in Toronto, Canada and it has been voted as Toronto's Best Tech Startup 2019 and was named one of the top 10 'Canadian AI Startups to Watch' as well as one of 6th International finalists for the VW Siemens Startup Challenge, resulting in a partnership. His latest app Xesto-Fit demonstrates how advanced AI and machine learning is applied to the e-commerce industry, as a result of which Xesto has been recently featured in TechCrunch. He specializes in both applied and theoretical machine learning and has extensive experience in both industrial and academic research. He is specialized in Artificial Intelligence with multiple industrial applications. At Xesto, he leads projects that focus on applying cutting edge research at the intersection of spatial analysis, differential geometry, optimization of deep neural networks, and statistics to build scalable rigorous and real time performing systems that will change the way humans interact with technology. In addition, he is a Ph.D candidate in the Mathematics department at UofT, focusing on applied mathematics. His academic research interests are in applying advanced mathematical methods to the computational and statistical sciences. He earned a Bachelor's and MSc in Mathematics, both at the University of Toronto. Having presented at research seminars as well as instructing engineers on various levels, he has the ability to distill advanced theoretical concept to diverse audiences on all levels. In addition to research, our key expert is also an avid traveler and plays the violin. 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
About this Virtual Instructor Led Training (VILT) This 5 half-day Virtual Instructor Led Training (VILT) course will assist energy professionals in the planning and operation of a power system from renewable energy sources. The VILT course will discuss key operating requirements for an integrated, reliable and stable power system. The unique characteristics of renewable energy are discussed from a local, consumer centric and system perspective, bringing to life the ever-changing paradigm in delivering energy to customers. The course will explore the technical challenges associated with interconnecting and integrating hundreds of gigawatts of solar power onto the electricity grid in a safe and reliable way. With references to international case studies, the VILT course will also demonstrate the state of the art methodologies used in forecasting solar power. The flexibility of the invertor-based resources will facilitate higher penetrations of photovoltaic, battery electricity storage systems and demand response while co-optimizing customer resources. The contribution of inverter-based generators that provides voltage support, frequency response and regulation (droop response), reactive power and power quality with a high level of accuracy and fast response will be addressed. Furthermore, this VILT course will also describe how microgrids' controllers can allow for a fully automated energy management. Distributed energy resources are analyzed in detail from a technical and financial aspect and will address the best known cost based methodologies such as project financing and cost recovery. Training Objectives Upon completion of this VILT course, participants will be able to: Learn about renewable energy resources, their applications and methods of analysis of renewable energy issues. Review the operational flexibility of renewable energy at grid level, distribution network and grid edge devices. Understand and analyze energy performance from main renewable energy systems. Get equipped on the insights into forecasting models for solar energy. Predict solar generation from weather forecasts using machine learning. Explore operational aspects of a complex power system with variability from both the supply & demand sides. Manage the impact of the design of a Power Purchase Agreement (PPA) on the power system operation. Target Audience Engineers, planners and operations professionals from the following organizations: Energy aggregators who would like to understand the system operations of renewable energy power plants Renewable energy power system operator Energy regulatory agencies who aim to derive strategies and plans based on the feedback obtained from the power system operations Course Level Basic or Foundation Training Methods The VILT course will be delivered online in 5 half-day sessions comprising 4 hours per day, including time for lectures, discussion, quizzes and short classroom exercises. Course Duration: 5 half-day sessions, 4 hours per session (20 hours in total). Trainer Your first expert course leader is a Utility Executive with extensive global experience in power system operation and planning, energy markets, enterprise risk and regulatory oversight. She consults on energy markets integrating renewable resources from planning to operation. She led complex projects in operations and conducted long term planning studies to support planning and operational reliability standards. Specializing in Smart Grids, Operational flexibilities, Renewable generation, Reliability, Financial Engineering, Energy Markets and Power System Integration, she was recently engaged by the Inter-American Development Bank/MHI in Guyana. She was the Operations Expert in the regulatory assessment in Oman. She is a registered member of the Professional Engineers of Ontario, Canada. She is also a contributing member to the IEEE Standards Association, WG Blockchain P2418.5. With over 25 years with Ontario Power Generation (Revenue $1.2 Billion CAD, I/S 16 GW), she served as Canadian representative in CIGRE, committee member in NSERC (Natural Sciences and Engineering Research Council of Canada), and Senior Member IEEE and Elsevier since the 90ties. Our key expert chaired international conferences, lectured on several continents, published a book on Reliability and Security of Nuclear Power Plants, contributed to IEEE and PMAPS and published in the Ontario Journal for Public Policy, Canada. She delivered seminars organized by the Power Engineering Society, IEEE plus seminars to power companies worldwide, including Oman, Thailand, Saudi Arabia, Malaysia, Indonesia, Portugal, South Africa, Japan, Romania, and Guyana. Your second expert course leader is the co-founder and Director of Research at Xesto Inc. Xesto is a spatial computing AI startup based in Toronto, Canada and it has been voted as Toronto's Best Tech Startup 2019 and was named one of the top 10 'Canadian AI Startups to Watch' as well as one of 6th International finalists for the VW Siemens Startup Challenge, resulting in a partnership. His latest app Xesto-Fit demonstrates how advanced AI and machine learning is applied to the e-commerce industry, as a result of which Xesto has been recently featured in TechCrunch. He specializes in both applied and theoretical machine learning and has extensive experience in both industrial and academic research. He is specialized in Artificial Intelligence with multiple industrial applications. At Xesto, he leads projects that focus on applying cutting edge research at the intersection of spatial analysis, differential geometry, optimization of deep neural networks, and statistics to build scalable rigorous and real time performing systems that will change the way humans interact with technology. In addition, he is a Ph.D candidate in the Mathematics department at UofT, focusing on applied mathematics. His academic research interests are in applying advanced mathematical methods to the computational and statistical sciences. He earned a Bachelor's and MSc in Mathematics, both at the University of Toronto. Having presented at research seminars as well as instructing engineers on various levels, he has the ability to distill advanced theoretical concept to diverse audiences on all levels. In addition to research, our key expert is also an avid traveler and plays the violin. 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
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