21349 Courses

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face 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 23 Points   Development Level Develop

This course is not suitable for total beginners. To attend this course, you must already have some experience with industrial machines and be able to operate and set up a walking foot independently, or have attended our MODULE 3 – INDUSTRIAL MACHINE TRAINING. UNDERSTANDING THE CONSTRUCTION AND SEWING OF LEATHER GOODS: GUSSETS, FEATURES AND COMPONENTS This is the forth module of a series designed to provide thorough, professional training in leatherworking, leather sewing, bag and accessory making. Each module has been carefully designed to equip individuals with key skills for starting a career in this sector, broadening their industry knowledge, or embarking on their own journey with solid foundational skills. Through this lesson, you will learn how to construct, sew, and finish some of the most challenging parts of leather goods making, such as straps, handles, zips, pockets, and more. By working on various shapes and structures, you will gain insights into the technical aspects of leatherworking, including preparation, marking, cutting, gluing, reinforcing, skiving, and more. At the end of the lesson, you will have experienced a wide range of techniques, worked with numerous tools, used leatherworking sewing machines, and produced samples to take home with you. By the end of the lesson, you will have: – Received an introduction to leather preparation, pattern placement, and leather marking – Received an overview of leather cutting, gluing, reinforcing and skiving – Learned how to sew and finish zips on leather – Learned how to cut, assemble, and sew simple straps and handles – Gained knowledge on incorporating two types of lining in your project – Learned how to assemble and sew simple gussets – Learned how to construct simple and zipped pockets Included in the course: You will receive useful paper handouts containing: – A list of tools and materials used during the lesson(s), with descriptions and usage instructions – A list of recommended suppliers for leather and fittings, both in London and online – A glossary containing information about leather goods components Find all modules here: https://the-london-leather-workshop.cademy.co.uk/

Duration 3 Days 18 CPD hours This course is intended for The CompTIA Cloud Essentials+ Specialty certification is relevant to IT specialists, IT technical services specialists, IT relationship managers, IT architects, consultants, business and IT management, business process owners, and analysts. Overview Upon successful completion of this course, students will be able to: Learn the fundamental concepts of cloud computing. Learn the business aspects and impact of cloud computing. Differentiate the types of cloud solutions and the adoption measures needed for each. Identify the technical challenges and the mitigation measures involved in cloud computing. Identify the steps to successfully adopt cloud services. Identify the basic concepts of ITIL and describe how the ITIL framework is useful in the implementation of cloud computing in an organization. Identify the possible risks involved in cloud computing and the risk mitigation measures, and you will also identify the potential cost considerations for the implementation of cloud and its strategic benefits. Students will weigh the pros and cons of cloud computing to make effective decisions and meet IT challenges. 1 - Understanding Cloud Computing Concepts Topic A: Understand Basic Cloud Concepts and Terms Topic B: Identify Cloud Network and Cloud Storage Technologies Topic C: Recognize Cloud Design Aspects 2 - Applying Cloud Business Principles Topic A: Relate Cloud Concepts to Business Principles Topic B: Establish Cloud Vendor Relations Topic C: Distinguish the Financial Aspects of Engaging a Cloud Service Provider Topic D: Report Financial Expenditures 3 - Advising a Cloud Design and Migration Topic A: Relate Cloud Concepts to Cloud Design and Migration Topic B: Use Cloud Assessments Topic C: Manage Cloud Design Topic D: Compare Cloud Migration Approaches Topic E: Identify Benefits and Solutions of Cloud Services 4 - Operating in the Cloud Topic A: Relate Cloud Concepts to Technical Operations Topic B: Identify the Technical Aspects of Cloud Operations Topic C: Understand DevOps in the Cloud Topic D: Explain Cloud Security Concerns, Measures, and Concepts 5 - Managing Cloud Governance Topic A: Relate Cloud Concepts to Governance Topic B: Apply Risk Management Concepts Topic C: Understand Compliance and the Cloud Topic D: Manage Policies and Procedures for Cloud Services 6 - Appendix A: Mapping Course Content to the CompTIA Cloud Essentials+ (Exam CLO-002) 7 - Appendix B: CompTIA Cloud Essentials+ (Exam CLO-002) Acronyms 8 - Glossary 9 - Index Additional course details: Nexus Humans CompTIA Cloud Essentials Plus Certification (Exam CLO-002) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the CompTIA Cloud Essentials Plus Certification (Exam CLO-002) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Gain the knowledge and skills to safely insert and manage peripheral IV cannulas with our training course for healthcare professionals. Ideal for nurses, medical personnel, and other practitioners.

The aim of this module is to enable delegates to perform entry-type injured person rescue operations, in a Wind Turbine Generator, using industry standard rescue equipment, rescue methods and techniques, exceeding those of GWO Working at Heights. Valid GWO BST Module Working at Heights, GWO First aid and GWO Manual Handling certificates are prerequisites for participation.

This Level 3 Course is a full 3 day first aid at work course which is designed to help higher risk organisations. We can come nationwide or you can come to us.

ILM Level 3 Certificate in Leadership & Management – 9 day Accredited training course delivered in Nottingham A course for supervisors and junior managers which brings tangible benefits to the participants and to their organisations through applying the concepts taught at each stage directly to the work environment. The course is assessed in a practical manner through work based assignments for which tutorial guidance is supplied. The course is delivered in an interactive way to appeal to a variety of learning styles and to encourage participation.

PMI-ACP® Exam Prep This course builds on the candidates' practical experience of Agile in the workplace to equip them with the broad range of knowledge and skills required for the PMI® Agile Certification exam. It will follow the PMI® requirements and reference the suggested reading list, including the Agile Practice Guide, but will not be limited to those areas. Within the profession and discipline of project management, Agile continues to develop as a significant and important aspect of bringing change to an organization. Where the products of change must be delivered to the business 'on time,' Agile is often the chosen methodology. In addition to equipping candidates for the PMI® Agile Certification examination, this course will also support candidates in taking a more informed and effective role in Agile projects. It will also enable them to take a significant role in encouraging and enabling the organization to become or develop as an Agile environment. What you will Learn You will learn how to: Appreciate the wider aspects of Agile project management tools and techniques Integrate various disciplines within Agile Tailor / customize Agile to suit the needs of different projects Prepare yourself for the PMI® Agile Certification examination Getting Started Introductions Agenda Expectations Foundation Concepts Defining 'Traditional' Project Management Project management parameters The 'traditional' approach to the parameters Strengths and weaknesses of the traditional approach Defining 'Agile' Project Management Project management parameters revisited The 'agile' approach to the parameters Strengths and weaknesses of agile Managing projects with traditional and agile methods Can the two approaches co-exist? Leveraging the benefits of both methods Options for using both methods on a project Avoiding the elephant traps Key aspects of the PMI® Agile Certified Practitioner (PMI-ACP)® Handbook Overview Eligibility requirements Exam information Exam Blueprint Continuing certification requirements Key aspects of the PMI Agile Certification Examination Content Outline Introduction Agile exam content outline Tools and techniques Knowledge and skills Domains and tasks (not examined) An Introduction to Agile and Implementing Agile Definable work vs. high-uncertainty work Project factors that influence tailoring The Agile Manifesto and 12 Principles Agile mindset Agile domains and tasks Agile Tools and Techniques Related to PM 'Hard Skills' Planning, monitoring, and adapting The need for planning, monitoring, and adapting The Agile approach to planning and plans The Agile planning tools and techniques The Agile monitoring tools and techniques The Agile approach to adapting Product quality A definition of 'product quality' Setting the standard for product quality Agile tools and techniques for achieving product quality Risk management A definition of 'risk' What is 'at risk'? The acceptability of risks The Agile tools and techniques for managing risks Agile Tools and Techniques Related to PM 'Soft Skills' The difference between PM 'hard and soft' skills Communications The importance of communications Forms of agile communications Communications within the project Communications from the project Communications to the project Making communications the cultural norm Interpersonal Skills Defining and understanding management Defining and understanding leadership Defining and understanding servant leadership Delegating vs. empowering Playing to people's strengths Overcoming the roadblocks Core Agile Tools and Techniques The philosophy of core Agile tools and techniques Agile estimation Will traditional forms of estimating work for agile? The relationship between estimating and guessing The relationship between estimating and sizing The where, who, and how of agile estimating Agile analysis and design Product analysis and design from a user point of view Product analysis and design from a supplier point of view Product analysis and design from an agile project point of view Value-Based Agile Tools and Techniques The role of value-based tools and techniques in bridging traditional PM with Agile Value-based prioritization Value-based prioritization and agile projects Investment appraisal methods Regulatory driven Customer driven Ranking methods (MMF, MoSCoW) Metrics What should we measure / track? Methods of measuring / tracking Adding value with metrics Process Improvement Value-stream analysis Value-stream mapping Agile Knowledge and Skills Context of Agile Knowledge and Skills vis-à-vis Agile Tools and Techniques Agile Knowledge and Skills Process focused People focused Product focused Project focused Exam Preparation and Course Closure The application process - where are you now? The 'Exam-Focused Journal' - what you still have to do Further preparation - self-study schedule Exam topic review Practice exam Practice exam debrief Course closure

PMI-ACP® Exam Prep: In-House Training This course builds on the candidates' practical experience of Agile in the workplace to equip them with the broad range of knowledge and skills required for the PMI® Agile Certification exam. It will follow the PMI® requirements and reference the suggested reading list, including the Agile Practice Guide, but will not be limited to those areas. Within the profession and discipline of project management, Agile continues to develop as a significant and important aspect of bringing change to an organization. Where the products of change must be delivered to the business 'on time,' Agile is often the chosen methodology. In addition to equipping candidates for the PMI® Agile Certification examination, this course will also support candidates in taking a more informed and effective role in Agile projects. It will also enable them to take a significant role in encouraging and enabling the organization to become or develop as an Agile environment. What you will Learn You will learn how to: Appreciate the wider aspects of Agile project management tools and techniques Integrate various disciplines within Agile Tailor / customize Agile to suit the needs of different projects Prepare yourself for the PMI® Agile Certification examination Getting Started Introductions Agenda Expectations Foundation Concepts Defining 'Traditional' Project Management Project management parameters The 'traditional' approach to the parameters Strengths and weaknesses of the traditional approach Defining 'Agile' Project Management Project management parameters revisited The 'agile' approach to the parameters Strengths and weaknesses of agile Managing projects with traditional and agile methods Can the two approaches co-exist? Leveraging the benefits of both methods Options for using both methods on a project Avoiding the elephant traps Key aspects of the PMI® Agile Certified Practitioner (PMI-ACP)® Handbook Overview Eligibility requirements Exam information Exam Blueprint Continuing certification requirements Key aspects of the PMI Agile Certification Examination Content Outline Introduction Agile exam content outline Tools and techniques Knowledge and skills Domains and tasks (not examined) An Introduction to Agile and Implementing Agile Definable work vs. high-uncertainty work Project factors that influence tailoring The Agile Manifesto and 12 Principles Agile mindset Agile domains and tasks Agile Tools and Techniques Related to PM 'Hard Skills' Planning, monitoring, and adapting The need for planning, monitoring, and adapting The Agile approach to planning and plans The Agile planning tools and techniques The Agile monitoring tools and techniques The Agile approach to adapting Product quality A definition of 'product quality' Setting the standard for product quality Agile tools and techniques for achieving product quality Risk management A definition of 'risk' What is 'at risk'? The acceptability of risks The Agile tools and techniques for managing risks Agile Tools and Techniques Related to PM 'Soft Skills' The difference between PM 'hard and soft' skills Communications The importance of communications Forms of agile communications Communications within the project Communications from the project Communications to the project Making communications the cultural norm Interpersonal Skills Defining and understanding management Defining and understanding leadership Defining and understanding servant leadership Delegating vs. empowering Playing to people's strengths Overcoming the roadblocks Core Agile Tools and Techniques The philosophy of core Agile tools and techniques Agile estimation Will traditional forms of estimating work for agile? The relationship between estimating and guessing The relationship between estimating and sizing The where, who, and how of agile estimating Agile analysis and design Product analysis and design from a user point of view Product analysis and design from a supplier point of view Product analysis and design from an agile project point of view Value-Based Agile Tools and Techniques The role of value-based tools and techniques in bridging traditional PM with Agile Value-based prioritization Value-based prioritization and agile projects Investment appraisal methods Regulatory driven Customer driven Ranking methods (MMF, MoSCoW) Metrics What should we measure / track? Methods of measuring / tracking Adding value with metrics Process Improvement Value-stream analysis Value-stream mapping Agile Knowledge and Skills Context of Agile Knowledge and Skills vis-à-vis Agile Tools and Techniques Agile Knowledge and Skills Process focused People focused Product focused Project focused Exam Preparation and Course Closure The application process - where are you now? The 'Exam-Focused Journal' - what you still have to do Further preparation - self-study schedule Exam topic review Practice exam Practice exam debrief Course closure

Trapeze Table/Cadillac/Tower, Chair, and Barrels The Balanced Body Pilates Apparatus instructor training programme completes the full Pilates instructor certification program.