2406 Courses

QA Level 2 Award In Principles Of COSHH (RQF) Face to Face: Half-day course Virtual Classroom: Spread over 2 sessions of 2½ hr duration COSHH: Control of Substances Hazardous to Health Regulations 2002 Hazardous substances are everywhere, and COSHH assessments have to be undertaken in all businesses Run in an engaging and interactive way - see the video below Course Contents: Legal requirements relating to hazardous substances in the workplace Employer duties Employee duties Consequences of non-compliance Communicating safety information The different forms that hazardous substances can take Effects that may arise after exposure to hazardous substances The different routes that hazardous substances can enter the body How risk assessments reduce accidents and ill health at work The five step process of risk assessment The control hierarchy in relation to the safe use, handling, transporting, storage and disposal of substances hazardous to health Information to refer to when identifying and using hazardous substances Procedures for dealing with an incident involving hazardous substances Benefits of this course: COSHH stands for the 'Control of Substances Hazardous to Health' and falls under the Control of Substances Hazardous to Health Regulations 2002 This half day course is for all those who work, or wish to work, in a workplace that works with hazardous substances, such as in healthcare, in the manufacturing sector, cleaners, transport, utilities and even office environments Hazardous substances are everywhere, and COSHH assessments have to be undertaken in all businesses Candidates will learn about the legal requirements relating to hazardous substances, how risk assessments contribute to the safe use of hazardous substances, as well as the precautions and procedures required to ensure that the risks associated with hazardous substances are properly controlled Accredited, Ofqual regulated qualification: This QA Level 2 Award in Principles of COSHH (RQF) Course is a nationally recognised, Ofqual regulated qualification accredited by Qualsafe Awards.This means that you can be rest assured that your Principles of COSHH Certificate fulfills the legal requirements and is a very good way to make sure you and your employees are trained appropriately.The Ofqual Register number for this course is 603/0775/4

EA/PA Excellence Workshop Live from London on the 25th of April 2024. Featuring Keynote speaker Reggie Love, former Special Assistant to 44th President of the USA, Barrack Obama. Panel featuring Sophie Chapman, assistant to Steven Bartlett entrepreneur, author, host of the diary of a CEO and youngest ever dragon on BBC's Dragon's Den, Victoria Wratten, CEO of the Executive & Personal Assistants Association. The workshop contains, panel talk, keynote talk and facilitation over key topics from Kate Wood over the course of the day.

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

Create time to slow down and release any stress with this gentle Yin Yoga class. Natasha from Butterfly Minds will guide you through a relaxing sequence of postures, close to or on the ground, to help you release any physical tension while becoming more present and connected to yourself. In a Yin Yoga class, poses are held for longer periods, allowing you to fully relax into the postures and experience a deep sense of stillness. Suitable for all levels, this class offers a meditative environment to reconnect with your body and breath, while gently increasing your range of motion. Whether you're new to yoga or an experienced practitioner, Yin Yoga provides the space to slow down, reflect, and restore balance in both body and mind. This class is sponsored by The Volant Charitable Trust Small Grants Programme, administered by Foundation Scotland. Meeting in the studio at 1.15pm and then decide if the weather is fine to go to Saughton Park It is FREE and is aimed at WOMEN only from ETHNIC MINORITY BACKGROUNDS living in Edinburgh as per this funding application . This means “international”, from every foreign country. (Irish, any other white background, mixed ethnic, Asian/Asian British, Black/African/Caribbean, Black British, Arabic or other ethic groups) However we do welcome locals too so just sign up. We prioritize the area of Gorgie-Dalry-Saughton where our studio is based.  By attending this class you release the teacher, Giada Gaslini and Art and Spirituality Cic, from any liability arising out of any personal injuries, emotional or physical release, death, expectations of results, theft in the venue or damages that may happen to people and objects while attending.

Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. 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, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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

Come to join our new Tai Chi sessions with Yiyang, who has a deep rooted background in traditional Chinese inward training, breath-based therapy and historical study in Yoga and Buddhism. She will lead us with a gentle, low-impact form of movements, performing a series of deliberate, flowing motions while focusing on deep, slow breaths. The practice aims to benefit physical and mental health, concentrate the mind, and balance the body’s energy harmoniously with nature. 10:30-11:30am, every Thursday. Book a spot for you and your families or friends.

Management of Risk (M_o_R®) Practitioner The M_o_R® Practitioner course has been designed to provide learners with the opportunity to practice the practical application of the M_o_R method and covers the twelve M_o_R principles: Approach, Process and the basic techniques essential to managing risks using the M_o_R guidance. The purpose of the M_o_R Practitioner qualification is to confirm that the learner has achieved sufficient understanding of how to apply and tailor M_o_R in a scenario situation. What you will Learn At the end of the M_o_R Practitioner course, learners will gain competencies in: M_o_R framework (principles, approach based on risk documentation, process steps, and embedding and reviewing M_o_R principles Outline of M_o_R approach documents (including policy, process guide, and risk communications plan) Risk identification, assessment, and control Embedding and reviewing M_o_R M_o_R organizational perspectives (strategic, program, project, operational) Benefits The M_o_R Practitioner course offers a wide-ranging set of guidelines that will help in the management of risk in a project or program environment. It will help prepare learners for the M_o_R Practitioner Exam. They will feel more confident in approaching risk management after attending the course and will be aware of the use of different techniques that can assist in this task, including: Improved basis for effective strategy formation Reduced time spent fire-fighting and fewer unwelcome surprises Increased likelihood of successful change initiative outcomes Closer internal focus on doing the right things properly Increase in efficient use of resources waste and fraud Better management of contingency resources M_o_R roles and responsibilities M_o_R health check M_o_R maturity model Risk specialisms (including business continuity management) Introduction Introduction to the course What is a risk? What is risk management? Why is risk management so important? Basic risk definitions The development of knowledge about risk management Corporate governance and internal control Where and when should risk management be applied? M_o_R Principles The purpose of M_o_R principles Aligns with objectives Fits the context Engages stakeholders Provides clear guidance Informs decision-making Facilitates continual improvement Creates a supportive culture Achieves measurable value Risk management maturity models M_o_R Approach Relationship between the documents Risk management policy Risk management process guide Risk management strategy Risk register Issue register Risk response plan Risk improvement plan Risk communications plan M_o_R Process Common process barriers Identify - contexts Identify - the risks Assess - estimate Assess - evaluate Plan Implement Communication throughout the process M_o_R Perspectives Strategic perspective Programme perspective Project perspective Operational perspective Risk Specialisms Business continuity management Incident and crisis management Health and Safety management Financial risk management Environmental risk management Reputational risk management Contract risk management

PRINCE2® Foundation Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends

Management of Value (MoV®) Foundation This interactive MoV® Foundation course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn Upon completion of an MoV course candidates should be able to discuss and explain: The main processes and techniques used within MoV and the reasons for using them How MoV may be applied at portfolio, program, project and operational levels The differences in applying MoV at different stages in a project and the expected outputs from a MoV Study at each stage The circumstances under which MoV should be used The concept of value and how value may be improved The main benefits arising from the use of MoV Approaches for implementing MoV How to respond to external and internal influences The principles of embedding MoV into an organization The key topics in document checklists, the toolbox, health check, organizational maturity and individual competence. Upon successful completion of this course, you will be able to: Organize and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach and environment Analyse a company, program or project to establish its organizational value; includes identification and weighting of Value Drivers Pass the AXELOS MoV Foundation Examination Introduction to value management and MoV Value and Value Management Capabilities, Outcomes, Benefits and Disbenefits What is Value? What is Management of Value (MoV)? Why use MoV? Where use MoV? When MoV should be used? What using MoV involve? Selected MoV benefits Relationship with other AXELOS Global Best Practices and Models How MoV fits with other AXELOS Global Best Practice Guides MoV principles Align with organization's objectives Focus on functions and required outcomes Balance the variables to maximise value Apply throughout the investment decision Tailor MoV to suit the subject Learn from experience and improve Assign clear roles and responsibilities and build a supportive culture MoV processes Frame the programme or project Gather information Analyse information Process information Evaluate and select Develop Value Improving Proposals Implement and share outputs MoV techniques Function Analysis Function Analysis System Technique (FAST) Traditional (or classic) FAST Technical FAST Customer FAST Value Trees Measuring value Value profiling (a.k.a. value benchmarking) Simple multi-attribute rating technique (a.k.a. SMART) Value index Value metrics Value for money (VfM) ratio Value Engineering / Analysis Common techniques used in MoV Analysis of information Benchmarking Process Mapping Root Cause Analysis Discounted Cash Flow Analysis Generating Ideas Brainstorming Evaluation and option selection Option Selection Matrix Idea selection Allocation to Categories Idea Selection Matrix Weighting techniques Paired Comparisons Points Distribution Developing VIPs Developing Proposals Cost Benefit Analysis Building Decisions Implementing VIPs Implementation Plans Feedback Following up Tracking Benefits Approach to Implementation Generic approach to MoV implementation Plan the MoV activities Understand and articulate value Prioritize value Improve value Quantify value Monitor improvements in value Learn lessons Environmental factors Portfolio Considerations Programme considerations Project considerations Operational Considerations Embedding MoV into an organization Benefits of Embedding MoV into an organization MoV Policy MoV Policy Composition Embedding MoV into an organisation Key steps Suggested MoV Management Structure Overcoming barriers We do it anyway It takes up too much time We can't afford to make the changes What's in it for me? Don't fix it if it ain't broke Fixed returns on investment MoV products Briefing Meeting Agenda (A.1) Communications Checklist (A.2) Equipment list for an Effective Study/Workshop (A.3) Invitation to join the Study Team (A.4) Option Evaluation Matrix (A.5) Plan the Study (A.6) Recording Idea Selection (A.7) Reporting Study outputs (A.8) Scoping the Study (A.9) Study or Workshop Handbook (A.10) Value-Improvement Proposal Forms (A.11) Value Improvement Tracking Report (A.12) MoV toolbox MoV health check and maturity model P3M3 Maturity Model MoV Maturity Model (aligned with P3M3)

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