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
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A course for leisure and professional boaters wanting to undertake more adventurous trips by day and night, this 2 day course, with at least one night navigation exercise, will provide you with an RYA Advanced Powerboat Course Completion certificate. Anyone undertaking this course must have practical skills of the Intermediate level and theory knowledge of at least Coastal Skipper/Yachtmaster level. The course is split between theory and practical, with an emphasis on the application of theory knowledge to practical situations including preperation for sea, passage and pilotage making, skippering (meteorology, rules ofg the road)), navigation at planing speed, night cruising, and emergency situations. The Advanced Powerboat Certificate of Competence can only be issued after an exam, usually taken immediately after the course. If you are looking to take this exam, please let us know and we will arrange an examiner for you. The cost of this exam is payable directly to the RYA. To take this exam your must meet the following pre-requisites: 2 years relevant experience including night pilotage As a guide; 30 days at sea, 2 days as skipper, 800 miles, 12 night hours in the past 10 years Hold a valid First Aid certificate Hold a GMDSS Short Range Certificate (SRC) or higher grade marine radio certificate Age 17 or over Power Courses Our powerboat training is currently delivered on an MCA coded 7.8m Ribcraft with a 200hp Suzuki four stroke outboard engine and an E-series Raymarine chart plotter. We maintain a 3:1 student to instructor ratio which allows our experienced RYA instructors to tailor courses to the various levels and needs on board and deliver at a manageable pace. All course costs include tea and coffee, waterproofs are available on request.
We are very pleased to announce that Stephen Goldsmith aka the Gold polishing Guru is coming to our workshop 925 to teach his polishing masterclass. If you’re in the industry, he needs no introduction but for anyone who hasn’t heard of him, he is a master of the polishing craft with over 50 years experience, his client list past and present includes, Asprey, Garrard, Theo Fennell, Hamilton and Inches Crown Jewellers of Scotland, The Royal Mint, The Royal Society. He has polished and restored many famous silverware pieces including the Americas Cup; Davis Cup; Wimbledon Cup and the Premier League Cup and he has also advised the Tower of London Jewel House on the upkeep of their silver collections. He also judged the polishing section of Goldsmiths craft and design awards. WHEN: Thursday 31st October and Friday 1st November 2024 WHERE: Workshop 925 based at The Mayford Centre, just outside of Woking and very close to Guildford. Unit F9 The Mayford Centre, Mayford Green Woking, Surrey GU22 0PP TUTOR: Stephen M Goldsmith ABOUT STEPHEN: Stephen M Goldsmith started out at Rochester Art college, now known as University for the Creative Arts and was apprenticed at C.J Vander’s in 1971 and indentured with The Worshipful Company of Goldsmiths’. Now a Master Polisher of over 50 years’ experience, originally working for the Crown Jewellers Asprey & Garrards and well-known society jeweller Theo Fennell. Many of the pieces polished are now seen in Palaces, Museums and the rich and famous across the world. Stephen is one the most respected jewellery & silver polishers and is currently is teaching polishing across Europe and is known affectionately as “The Gold polishing Guru”. He has polished and restored many famous silverware pieces including the Americas Cup; Cricket World cup, Wimbledon Cup, Dubai Gold Cup, Premier League Cup. He has also been privileged to work in the jewel house at the Tower of London restoring The Grand Punch bowl made in 1830 and used by the Royal family on many occasions. Also known for polishing the largest pure gold coins made by the Royal Mint the largest being the James Bond 7kg pure gold coin. He is a fellow of the Institute of Professional Goldsmiths (IPG) and their official ambassador and a Master of The Dutch Guild of Goldsmiths. He shares his trade skills by teaching nationally and internationally including at Goldsmiths Centre, School of Master Jeweller’s Birmingham and VanTol & Breet Academy (Netherlands), The School of Jewellery Dublin & The Design & Craft Irish Craft Council in Kilkenny, Vannilla Ink, Aka_bespoke Manchester, Sheila Fleet in Orkney, Patrick Mavros in Zimbabwe and Mauritius. Stephen is a Freeman of The Worshipful Company of Goldsmiths’ and was granted the Freedom of the City of London in 1975. He has also had the very rare honour of winning The Goldsmith’s Company Award twice, plus many other prestigious awards and served as a council member for The Goldsmiths’ Craft and Design Council and a published authority on polishing precious metals “Polishing and Finishing for Jewellers and Silversmiths by the Crowood Press. WHAT DOES THE DAY INVOLVE? We are very pleased to announce that Stephen Goldsmith aka the Gold polishing Guru is coming to our workshop 925 to teach his polishing masterclass. If you’re in the industry, he needs no introduction but for anyone who hasn’t heard of him, he is a master of the polishing craft with over 50 years experience, his client list past and present includes, Asprey, Garrard, Theo Fennell, Hamilton and Inches Crown Jewellers of Scotland, The Royal Mint, The Royal Society. He has polished and restored many famous silverware pieces including the Americas Cup; Davis Cup; Wimbledon Cup and the Premier League Cup and he has also advised the Tower of London Jewel House on the upkeep of their silver collections. He also judged the polishing section of Goldsmiths craft and design awards.You can get a glimpse of what he does on his instagramWHAT HAPPENS DURING THE MASTERCLASS?First, Stephen will talk about his career giving you an insight into the makings of a master craftsman. Then he will demonstrate just why he is known as master polisher. After this demonstration you will be guided by Stephen to try and replicate what you have been shown in the demonstration.After working through a few more exercises you will set to work on your own jewellery, receiving guidance on not just how to achieve the finish you would like for your jewellery but to reach a standard of finish you didn’t know you could.These Masterclasses are a great opportunity to learn from someone who is:a) A true master in our tradeb) Not a grump or condescending because you don’t know somethingc) Happy to chat and share his knowledge!All you need to bring is some of your own jewellery (around 6 items) at the point where it’s ready for polishing.You will have a spindle that is yours for the duration of the masterclass, mops, materials etc will be provided. It can be a messy business so make sure your clothing is workshop friendly!You will also have full access to our workshop, benches, tools and equipment if needed.This Masterclass will leave you with the knowledge and skills to take your polishing to a highly professional standard.EXPERIENCE REQUIRED: This class will benefit jewellers with some experience who are looking to learn to polish their work to a professional level. Our small classes mean we are able to provide each student with the support they require. CLASS SIZE: 6 WHAT TO BRING: For safety reasons, during each class, you are required to wear appropriate footwear, we request that no open toed shoes are worn within Workshop 925. Long hair should also be tied back when working with the equipment. You may also wish to bring a notebook. We have handouts for many demonstrations, but there are always many tips and tricks given verbally by the tutor, which some might like to keep note of. We have a microwave, kettle and fridge to store or cook your lunch choices. PAYMENT OPTIONS: You can pay via our website or in our workshop in person using our card machine. If you prefer to pay directly, you can email us on hello@workshop925.com and we can invoice you manually to arrange a bank transfer. For classes over £80, instalment options are also available. Please email us on hello@workshop925.com to arrange. Gift Voucher – if you have a voucher to redeem, please email us before booking on hello@workshop925.com Please check your dates carefully before booking a class as we are unable to offer refunds. See our Terms & Conditions for full details.
Exclusive to AutoCAD subscribers, the AutoCAD Electrical toolset simplifies electrical system creation. Click here for more info: Website Our course provides a strong foundation in 2D electrical design, covering essential tools. Flexible one-on-one sessions from 9 a.m. to 7 p.m., Monday to Saturday. Call 02077202581 or book online. The 16-hour course offers flexibility, divide hours across days. Benefit from individualized attention and tailored content. Enroll for in-person or Zoom sessions to excel in AutoCAD Electrical. AutoCAD Electrical Course Content: Introduction to AutoCAD Electrical Software: Overview and features of AutoCAD Electrical Understanding the software interface and tools Project file structure and management Layout and Navigation: Navigating the AutoCAD Electrical workspace Creating new project files and using attribute editors Understanding WDD, WDX, and WDF project files Exploring the Project Manager interface and attribute editors Electrical Diagram Drawing: Numbering and titling wires in diagrams Labelling components Utilizing diagram symbol libraries Creating and editing Electrical Control Circuits (ECC) Component dialog box and Circuit Scale dialog box Introduction to Programmable Logic Controllers (PLCs) and Integrated Systems: PLC Symbols and Concepts Inserting Programmable Logic Controllers (PLCs) into diagrams Adding PLC Units to diagrams Working with PLC Input and Output points and circuits Understanding PLC-based classification Using the Spreadsheet to PLC Input and Output Points utility Custom and Bespoke Symbols: Creating custom symbols for Switches, Wires, Contactors, Motors, Transformers, etc. Specifying symbol conventions and standards Offline and online usage of AutoCAD Electrical databases Drawing for Terminals and Plans: Implementing Terminal symbols in diagrams Handling terminal plans and locations Working with compound level terminals and locations Utilizing the Component command for single and multiple components Managing Jumpers and wiring Modifying Terminal Strips and Dual In-Line Packages (DIP) Understanding DIN Rail, Electrical Enclosure, Circuit Breakers, and Electrical Equipment Generating PDFs and Reports: Exporting drawings to PDF format Organizing report templates Automating the generation of reports Creating Electrical Audit Reports This AutoCAD Electrical course provides comprehensive knowledge of the software, focusing on electrical diagram drawing, symbol creation, PLC integration, terminal planning, and report generation. Participants will gain the skills needed to efficiently design electrical systems using AutoCAD Electrical software. Upon completion, participants will proficiently use AutoCAD Electrical to create precise electrical diagrams, integrate PLCs, design custom symbols, plan terminals, and generate reports efficiently. They will possess the skills needed to confidently design electrical systems and enhance their expertise in electrical design and drawing. AutoCAD Electrical Training Course: Master precision in specialized electrical design skills. Optimize your design process with streamlined workflows. Ensure compliance with industry standards consistently. Boost productivity in electrical design tasks. Facilitate seamless collaboration with fellow professionals. Benefit from recorded lessons for convenient review. Enjoy continuous support with lifetime email assistance. Unleash the complete power of AutoCAD for your electrical design needs. Enroll today and craft precise, professional electrical drawings confidently. Select between in-person and live online sessions to suit your preference. Flexible Evening Sessions: Learn AutoCAD at your own pace with evening sessions designed for busy individuals. Boost your career opportunities in computer-aided design. Comprehensive Skill Development: Gain a strong foundation in AutoCAD's core features and advance to 3D modeling and rendering techniques, enhancing your design capabilities. Industry-Standard Knowledge: Become proficient in AutoCAD, a widely used CAD software in architecture, engineering, and construction fields, making you highly sought after by employers. Practical Application: Apply AutoCAD skills to real-world design scenarios, creating detailed plans for professional projects in architecture, engineering, and mechanical fields. Recorded Lessons for Review: Access lesson recordings to reinforce learning and review specific topics or techniques whenever needed. Lifetime Email Support: Enjoy ongoing support with lifetime email assistance, even after completing the course, for guidance and clarification.
Target Audience Early career business professionals, graduates or anyone aiming to behave, communicate and orient themselves appropriately in professional settings. Duration 1 Day Course Overview Business etiquette refers to the set of manners and behaviors (also referred to as the hidden curriculum) that are accepted or required in a professional setting. How does one establish a personal brand that fits within appropriate organisational brand and culture? This course answers that and more. It equips learners to contribute to their organisation in a highly professional and mutually respectful manner, using effective communication methods that scaffold positive relationships and facilitate productivity. This course is designed by highly qualified learning design experts, assisted and guided by a Doctoral & Masters level leadership team. Working closely with subject matter leaders with extensive domain experience, this course is built on sound academic rigour and applied real world experience. Run in a cohort-based, activity-led format, it goes beyond theory to provide practical methods and frameworks that you can immediately apply in your workplace. Key Outcomes Explain the importance of business etiquette Define personal and organisational brand and explore their relationship Demonstrate the ability to communicate professionally across all modes Apply social and emotional intelligence in professional relationship contexts Participate in and run meetings that are effective and professional Consider multi-cultural and other aspects of diversity during communication
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