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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

Focusing on you and your dog outside of a group class setting, in a 1-2-1 dog training session, can be really useful for you and your dog. We can focus on specific goals you may have, from teaching a dog a new game such as retrievals or flirt pole, to training for specific situation such good dog manners when guests come to our house. We can also develop a training plan to help address existing undesirable behaviours your experiencing such as your dog pulling on lead, your dog not performing recall, dog to dog reactivity, dog to person reactivity or even your dog chasing birds or squirrels.   1-2-1 dog training sessions are typically 1 hour or 1.5 hours long, depending on the issue, or number of things you want to look at in a single session. Training can be carried out in your home/ garden or out at an agreed location, such as a local park, if suitable for you and your dog's particular issue. I am also happy for you to travel to me to train your dog at an agreed location. 1-2-1 dog training prices: 1 hour = £60, including follow up report. 1.5 hours= £90, including follow up report. (Longer sessions can be arranged by agreement, priced on an individual basis.) Above prices are based on Dog Training being in and around Bishop's Stortford (IE Sawbridgeworth, Much Hadham, Little Hallingbury, Harlow, Puckeridge, Standon, Manudon), I am happy to travel, subject to agreed travel costs.

Your puppy training journey can begin before you even bring your puppy home. By ensuring you have the basics covered such as puppy crate training and puppy toilet training, you can start your journey off with your puppy in the best possible way.    Focusing on you and your puppy outside of a group class setting, in a 1-2-1 puppy training session, can be really useful for you and your puppy. We can focus on specific goals you may have, from teaching a puppy a new game such as retrievals or flirt pole, to training for specific situations such good puppy manners when guests come to our house. 1-2-1 puppy training sessions are typically 1 hour. Training can be carried out in your home/ garden or out at an agreed location, such as a local park, if suitable for you and your puppy goals. I am also happy for you to travel to me to train your dog at an agreed location. 1-2-1 puppy training prices: 1 hour = £60, including follow up report. Pre-arrival session= £30 (half hour) (Longer sessions can be arranged by agreement, priced on an individual basis.) Above prices are based on Dog Training being in and around Bishop's Stortford (IE Sawbridgeworth, Much Hadham, Little Hallingbury, Harlow, Puckeridge, Standon, Manudon), I am happy to travel, subject to agreed travel costs.

This 2-day workshop is offered with an internal and external focus. Day 1 will focus on building your internal network and relationships by focusing on your personal network, your brand, influencing skills and perceptions. Day 2 focuses on your external relationships with suppliers, patient groups etc. This will focus on assertiveness, outcome rather than relationship focus, and influencing and negotiating skills. DAY ONE 1 Can you succeed by yourself? 2 Relationship awareness theory 3 The Strengths Deployment Inventory / Your FACET5 profile 4 Building rapport 5 Influencing power bases 6 Active listening 7 Building your personal internal network 8 Perceptions 9 Your brand DAY TWO 3 Preparing for conflict 2 The negotiation conversation 1 Your stakeholders and what they want from you 4 Influencing others 5 Your communication approaches for success 6 Emotional Intelligence 7 The trust model 8 Knowing your outcomes

This 3-day FAA Level 3 Award course offers a variety of first aid situations and teaches how to respond to an emergency. It gives delegates the confidence to deal with any of these situations safely and efficiently.

Paediatric first aid training: What will you learn? The course covers everything listed below. There will be practical demonstrations, role playing and several activities to keep things moving along. You’ll use the whole range of paediatric first equipment, and will try out your newly learned techniques on my adult, child and baby mannequins. I’m happy to tailor the content with additions. If you want me to focus on a specific area of paediatric first aid, that’s fine. Here’s what you’ll learn: Responsibilities and reporting requirements Assessing a medical situation How to perform CPR Resuscitation and using a defibrillator Treatment of an unconscious casualty, and the recovery position Choking Head injuries Seizures, including febrile convulsions Bleeding and shock Burns and scalds Fainting Anaphylaxis, and using an EpiPen Diabetes and asthma emergencies Foreign objects Eye injuries Sprains, strains and fractures Heat and cold Sickle cell anaemia and meningitis