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
Develop your technical report writing and presentation skills with EnergyEdge's course designed for oil & gas professionals. Sign up now!
Develop your technical report writing and presentation skills with EnergyEdge's course designed for oil & gas professionals. Sign up now!
Discover Energy Edge's course on decarbonising maritime propulsion. Enhance your knowledge with our virtual instructor-led training for sustainable maritime solutions.
Gain expertise in healthcare training with our Level 3 Endorsed Award in Delivering Health and Social Care Training. Our comprehensive program equips you with the skills and knowledge to become a proficient trainer in the healthcare sector.
Become a certified Lean Six Sigma Green Belt with our dynamic, interactive, and project based training sessions, now running in the Republic of Ireland.
Develop your technical report writing and presentation skills with EnergyEdge's course designed for oil & gas professionals. Sign up now!
Our foundation lip filler course is designed for learners wanting to enter the industry at a beginner level and specialise in lip augmentation. Our goal at the Cosmetic College is to deliver the highest quality training in dermal fillers using the safest and most up-to-date techniques. Our courses are carried out in small groups; This enables us to provide you with a training programme tailored to your needs, with more time and emphasis on the hands-on practical sessions. Course Prerequisites This course is suitable for those with or without a medical background. It is designed to provide the student with the ability to seek employment or start their own business upon qualification. At a minimum, students will be required to be qualified at least one of the following: Medically qualified as a nurse, doctor or dentist with current registration with the NMC, GMC or GDC. NVQ Level 3 in Beauty Therapy, ITEC or HND 12 months of needling experience 6 Months micropigmentation experience and Anatomy & Physiology Level 3 Please note that if your qualification does not appear above, we offer a fast track access course for those completely new to the industry. Course Pre Study 40 hours of E-learning A series of online assessments 2 Days of Practical training Anatomy and physiology of the face Infection control Sharps and hazardous waste training First aid and anaphylaxis training Introduction to dermal filler injection techniques Elective and emergency dissolving Injection techniques practice Danger zones training Vessels, muscles, fat pads workshop Professional live demonstrations Legal requirements, obtaining consent with consultation techniques and documentation Practical training Clinical setup procedures Areas CoveredLips Professional KitDermal filler (Used for training) Numbing creamMassage gelChlorhexidine pre-injection wipesSterile treatment packsGlovesSurgical face masksSkin marker pencilsIce packConsultation forms
ProQual Level 3 Teaching Training and Assessment - PTLLS
Course Description Training will cover detailed anatomy and physiology of the lymphatic and associated vascular system, pathology of lymphoedema and chronic oedema and the different stages and types of lymphoedema. Please note: Your training will be delivered through a blended learning format. With our blended learning format, you will have the opportunity to complete the theoretical components of your training at your own pace. In addition to the online learning, we offer clinical skills training on scheduled workshop dates. This hands-on training will allow you to put your theoretical knowledge into practice and develop the necessary skills to excel in your field. Our experienced instructors will guide you through each step of the training, ensuring that you are fully prepared and confident in your abilities. Once you have completed your clinical skills training, you will receive your certification, validating your skills and knowledge. Please note price includes VAT Our Comprehensive Lymphoedema Training Course Course Summary Join us on our blended learning training programme especially designed for certified healthcare professionals working within clinical settings. By the end of the course, you will have a thorough understanding of the anatomy and physiology of the lymphatic system, enabling you to holistically assess and diagnose a patient with lymphoedema. You will be able to design and implement an appropriate research and evidence based individualised management strategy selecting from a range of therapies and new innovations. You will be competent in the field of Decongestive Lymphatic Therapy including Multi Component Bandaging (MCB) and the latest knowledge and research in Fluoroscopy Guided - Manual Lymphatic Drainage (FG-MLD®) Entry Requirements This training is suitable for: All certified healthcare professionals. Such as Medics, Registered General Nurses, Physiotherapists, Radiographers, Occupational therapists, Osteopaths and Chiropractors Learning Format Your course is made up of a blended learning format meaning your content and modules will be taught via live interactive webinars, through self-guided independent study and face to face clinical skills workshops. So, whether you're learning style is social, solitary, visual, kinesthetic, auditory or a combination we have a learning style to help you get the best out of the course. We hope that you make the most out of the tools that are available to you throughout the course but don't worry if you are not the most "tech-savvy", we have real people on hand to help you every step of the way. Assessment Criteria All students will undergo a series of course specific formative & summative assessments. Throughout the course you will be assessed through observation of practical tasks, written assessments, assignments, research and online tests. Course Contents You will gain knowledge, skills and techniques in: Compression Exercise Skincare & Wound Healing Garments Multi-Component Bandaging Assessment & Treatment of Oedema Anatomy & Pathways of the Upper & Lower Limb FG-MLD® Technique Tissue Dielectric Constant Head & Neck, Midline & Genital Oedema. Training will also cover innovations and consideration for clinical practice. Course Inclusions As part of your training pack, LTA will provide all training support materials required to undertake the course. Such as but not limited to: Corporate Sponsored Bandaging Pack LymphBalls™ Latest LTA Research & Development articles Lymphoedema supporting literature Access to in-house LTA training & demonstration videos Learning management platform (CANVAS) profile & course content Snacks & Refreshments throughout your practical skills workshops Dedicated support from the LTA training team Course Certification The benefits of an LTA certification means you can; Display FG-MLD® Certified and LTA Cert. logo on your marketing material Write LTA Cert. after your name Wear your qualification badge Practice MLD to further enhance outcomes Use an innovative technique and ensure effective treatment programmes Receive training and support from Jane Wigg & Team Access the latest developments in Lymphoedema care Have access to a private FG-MLD® Therapist FB Page Recertification To maintain your LTA Therapist Certification, a 2-day recertification is required after 12 months after your initial training, and you will be required to attend a 1-day recertification every 2 years thereafter to maintain your certification of practice.