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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

The course covers research design principles and all main quantitative evaluation methods: randomised experiments, instrumental variables, sharp and fuzzy regression discontinuity designs, regression methods, matching methods and longitudinal methods (before-after, difference-in-differences and synthetic controls).

Continuously evolving business and technology landscapes create new and transforming opportunities for entrepreneurs and companies that are prepared.

Ten live dialogues between Prof Ernesto Spinelli and International Existential Therapists followed by an Experiential Study Group. A phenomenological approach to re-view psychopathology: We aim to explore the lived experiences of irregular perceptions of reality with an open mind. Each Saturday includes a live dialogue between Prof Ernesto Spinelli and an International Existential Therapist; a moment to share your thoughts and feelings with the teachers; and a final integration facilitated by Bárbara Godoy. This series of ten Dialogues set out to explore the multifaceted dimentions and complexities associated with Existential Therapies. It attempts to engage with various interpretations of insanity through the lens of patients' often painful, confounding, and deeply unsettling life experiences. TIMES AND DATES 2025 25 Jan. “Knots” with Prof. Ernesto Spinelli 2 Feb. “Healing” with Dr. Michael Guy Thompson 22 Mar. “Difference” with Dr. Todd DuBose 12 Apr. “Polarization” with Prof. Kirk Schneider 3 May “Character” with Prof. Robert Romanyshyn 21 Jun. “Opening” with Dr. Yaqui Martinez 19 Jul. “Meaning” with Dr. Jan Resnick 25 Oct. “Invention” with Dr. Betty Cannon 15 Nov. “Hallucination” with Prof. Simon du Plock 13 Dec. “Hysteria” with Bárbara Godoy Full course (including dialogues): £1260 (2 pm to 5 pm – UK time) Only Dialogues: £630 (2 pm to 3 pm – UK time) Venue: Online Zoom Read the full Programme here > Course Organised by:

Mental Health and Wellbeing Training Courses Building resilience CPD Accredited, Interactive Workshops Enquire about this course 2-5 hour workshops Suitable for anyone who'd like to improve their mental wellbeing and resilience Giving them the chance to cope with life's challenges

LOOKING FOR: ADULT FICTION Louise Buckley has worked in publishing for well over a decade. She was inspired to enter the publishing industry after completing an MA in Creative Writing and then spent a hugely enjoyable year working as a bookseller for Waterstones, wishing that she could have a hand in publishing books. After a year working at Dorling Kindersley, she then spent almost five years working in the commercial fiction division at Pan Macmillan, where she published a mix of commercial bestsellers and award-winning authors. Most recently, she was an Associate Literary Agent at Zeno Agency Ltd. As an agent she represented a roster of commercial and literary fiction, including Anne Griffin’s When All is Said, which spent five weeks at number one in Ireland and sold into 17 territories. She is delighted to be working with Hannah at Hannah Sheppard Literary Agency. Louise is looking for:- Literary and upmarket fiction that focusses on the underdog, the repressed, the suppressed. Louise is especially interested in novels that represent working-class people or children going through difficult circumstances (think Shuggie Bain by Douglas Stuart, My Name is Leon by Kit de Waal or Boys Don’t Cry by FÍona Scarlett). Irish literary and book club fiction. Think Claire Keegan, Louise Kennedy or Anne Griffin. In commercial fiction she loves novels set during the Second World War, such as The Nightingale by Kristin Hannah, The Beekeeper of Aleppo by Christi Lefteri or The Midwife of Auschwitz by Anna Stuart. Louise recently read and loved The Last List of Mabel Beaumont by Laura Pearson and would love to see anything in the same ‘older person going on a journey’ category, a more recent The Unlikely Pilgrimage of Harold Fry. Louise had a lot of fun publishing a ‘pet fiction’ novel as an editor (Molly and the Cat Café) and would love to find an author who can write an Alfie the Doorstep Cat/Dog. She has a soft spot for novels featuring time-travel or parallel universes, a ‘what if’ that plays around with conventions. At the literary end this would be books like Life After Life by Kate Atkinson, The Shining Girls by Lauren Beukes or This is How You Lose the Time War by Amal El-Mohtar and Max Gladstone. At the more commercial end Louise loved Wrong Place, Wrong Time by Gillian McAllister, Dark Matter by Blake Crouch and Oona Out of Order by Martina Montimore. She also enjoys novels set in the real world but featuring a hefty dose of magic or the supernatural. They can be commercial or literary, present-day or historical. Think Rivers of London by Ben Aaronovitch, Threadneedle by Cari Thomas, A Discovery of Witches by Deborah Harkness or The Gifts by Liz Hyder. And also cosy fantasy in the vein of Legends and Lattes or The House in the Cerulean Sea. Cosy or humorous crime. Recently, Louise absolutely loved Over My Dead Body by Maz Evans. When she was an editor Louise published the hit Luckiest Girl Alive by Jessica Knoll and would love to represent incisive, intelligent suspense written by authors such as Jessica Knoll and Gillian Flynn, or something a little more subversive and blackly comic like My Sister, the Serial Killer by Oyinkan Braithwaite. More generally, Louise would also love to see novels with a disabled protagonist or someone (like myself) who is living with an invisible disability. As an ex-primary school teacher, she also warmly welcomes submissions from teachers, especially if the submission falls into one of the other categories she has listed. Following-on from this, she enjoys reading stories that follow a ‘beating the system’ narrative. Louise is NOT looking for: -romance -romantasy -epic, traditional fantasy -space opera -straightforward women’s fiction -children’s fiction of any kind -non-fiction Louise would like you to submit a covering letter, 1 page synopsis and the first three chapters or 5,000 words of your manuscript in a single word document. (In addition to the paid sessions, Louise is kindly offering one free session for low income/under-represented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print).  By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Friday 6 December 2024

LOOKING FOR: ADULT FICTION Clare set up the Liverpool Literary Agency in 2020 to help address inequality and underrepresentation in the publishing industry. With more than 15 years’ experience of writing and editing professionally, including the publication of two novels, Definitions (2015) and We Are of Dust (2018 - which has received development funding from the Liverpool Film Office for a TV adaptation), she has developed an in-depth knowledge of what commissioning editors and publishers expect to see from a submitted manuscript. With a background in PR and marketing, alongside teaching on creative writing programmes, Clare also has extensive experience in pitching and promoting writers and has been nominated for the Romantic Novelist Association Agent of the Year Award! Clare would love to see historical fiction, crime fiction, psychological thrillers and women’s fiction, but she is open to all great writing with a strong hook in any area (excluding non-fiction, children’s and YA). She actively encourages submissions from writers who have been traditionally under-represented. Clare would like you to submit a covering letter, 1 page synopsis and the first 5,000 words of your manuscript in a single word document. (In addition to the paid sessions, Clare is kindly offering one free session for low income/under-represented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print).  By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Monday 9 December 2024

LOOKING FOR: YA, NA, ADULT FICTION Helen Lane is an editor and a Junior Agent at The Booker Albert Literary Agency. She is passionate about books and has spent the last decade supporting authors. She will happily offer her editing advice on manuscripts through I Am In Print but in accordance with her membership of the Association of American Literary Agents (AALA), guidelines state that any work submitted to her for feedback cannot be considered for agent representation. What Helen will do during your session is assess your sample and provide detailed feedback on any identifiable issues, the manuscript's commercial potential and what steps she would advise before you begin querying. She does not require personalisation in the letter, comparison titles or a synopsis, but if you have them already, please include them. As an idea of the genres Helen represents, she would love to see and offer advice on Adult Fantasy, Sci Fi, Horror, Paranormal Romance, LGBTQ+ Romance, Action & Adventure & Thrillers and will also look at YA Fantasy. Books Helen is slightly obsessed with include monster stories (especially if they have giant sharks or squids) and stories set in extreme environments such as the arctic, jungle, caves, ocean, and mountains. She DOES NOT want to read about affairs or abuse in any genre. (Her husband likes her to add here that this is nothing to do with him; she just doesn't like sad stories). Her favourite authors are Mira Grant, Greig Beck, James Rollins, Matthew Reilly, Jennifer L. Armentrout, Darcy Coates, Patricia Briggs & Kelley Armstrong. Helen holds a BSc in Environmental Science from the University of East Anglia and a postgrad qualification in Acoustics. She lives in London with her family and the world’s naughtiest cocker spaniel. Follow Helen on social media: @HFLane_writing Helen would like you to submit a covering letter, 1 page synopsis and first three chapters (Max 5,000 words) of your manuscript in a single word document. (In addition to the paid sessions, Helen is kindly offering one free session for low income/under-represented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print).  By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Monday 9th December 2024

CIEH Level 3 Food Safety in manufacturing. Delivered online (Zoom) by a live tutor. Exam and Certificate fee included in the price.