Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. 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 and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 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
Are you thinking about setting up a new business? Her Biz, the 'virtual' Women's Start-Up programme is returning to support aspiring female entrepreneurs in East Sussex and Kent.
The Digital CCTV & Remote Access course is designed to give participants a practical knowledge of integrating Analogue and Digital technologies in addition to access and control from remote locations such as laptops, tablets and mobile phones.
Electronics Equipment Repair 2 (Online Virtual Classroom) is a follow on course to Electronics Equipment Repair 1. This course builds on the skills gained and enables participants to build, test and fault-find more complex Analogue Electronic circuits
Endometriosis masterclass. Whole day live surgical course demonstrating the full spectrum of endometriosis surgical management.
Learn tools to set workplace boundaries
When we come together to make SoulCollage® in community, amazing things happen. There is a magic in the paradoxes built into this journey that only requires you coming along with your curiosity and imagination. No artistic genius recquired whatsoever. Just your presence!
International markets offer huge Export opportunities for UK businesses. Finding and developing new markets for products is a hugely valuable avenue for expansion and in some sectors in particular, global demand for British brands and products makes international trade an excellent means of growth.
LOOKING FOR: YA/NA FANTASY, SFF, HORROR, ADULT FICTION John Baker (he/him) joined the Bell Lomax Moreton agency in 2019, cultivating a list shaped around his passion for science fiction, fantasy, and horror, though has lately also branched out into action/adventure fiction. John focuses on authors writing in the Adult, New Adult, and YA spaces. John leads the wider agency's film & TV desk, is the Secretary of the Association of Author’s Agents, and the co-chair of the AAA’s Bridge Committee. He also serves on the Kingston University MA Publishing Advisory Board. Under the umbrella of speculative fiction, John is looking for fantasy, science fiction, horror, romantasy, or literary speculative fiction. He has built a reputation as a champion of underrepresented voices and stories, be it from creators hailing from the global majority and their diasporas or neurodiverse authors, and naturally gravitates towards this kind of storytelling. In short, if he’s never read a story like yours before, he wants to see it. Adult fantasy: John loves beefy epic fantasy, especially non-Anglo Christian-inspired. Give him an immersive world, a fresh magical or mythic system, and an exciting cast of characters and he’ll be happy. He is a broad church in the genre so loves a political fantasy, swords and sorcery, courtly intrigue, monster hunting and dastardly villains. John is keen to find an urban fantasy that feels fresh and fun and he’s a sucker for a heroic quest narrative. He’s also very open to fantasy that isn’t easily categorised, but it is playing in that world. John is keenly hunting for more historical fantasy, especially inspired by modern history. He’s had fun with mythological retellings in the past, but as ever, let’s make sure it’s shining the spotlight on new stories. He would also love fantasy that centres on types of relationships less celebrated in fantasy, such as established and secure married couples, or siblings. NA/YA fantasy: In this genre, most importantly, John wants to have a good time, whether it’s swoon-worthy kisses in lush ball gowns, or gruesome gore and monsters, so send him pacy, plot-filled adventures. He’d love more books that teenage boys would love: Skullduggery Pleasant forever! Romantasy: The thriving new romantasy genre comes with its own set of challenges, so John wants to know what makes your romantasy different; what will set it out from the (very crowded!) market. Give it completely barmy stakes, cool and unique new settings, or a love story that will make your jaw drop. To be clear, he’s happily sorted for a human person meets a fae creature in the spooky woods. Also, cosmic romance is the genre of the future. Give him romantasy in space. Easy. Horror: John and horror are old friends. He loves horror inspired by myth and folklore, subversive weird horror that leaves your eyebrows in your hairline, historical horror that pulls from ghastly true stories, and anything that you’ll be reading with the light on. He also loves a gothic element and is particularly looking for horror with a strong romantic throughline, fun YA horror, and female & NB horror authors. Science fiction: SF is coming back! And John has been shouting about that. He loves to see an adventurous found-family romp through space or an epic, crunchy space opera. Speculative near-future is fun too, in the vein of Black Mirror’s more uplifting episodes, (e.g. San Junipero). He loves YA science fiction as well; the more creative the better. Literary: John is open to finding more rich magical realism or something character-led yet supernatural and would love a high-concept mystery, in the vein of Stuart Turton. He also loves spec fic that uses the speculative lightly as a way of confronting a deeper truth in society today. Weird stuff: John wants books that will blow people’s minds and defy categorisation. This is hard to describe, but think Gideon The Ninth, The Library At Mount Char, This Is How You Lose The Time War. John loves a pitch that leaves the editors baffled but intrigued. Action/Adventure, Historical Adventure, Espionage: John is branching out into non-speculative adventures, such as John Le Carré, Lee Child, Ian Flemming, and Mick Herron. More as his taste develops, but the hunt is on! Not looking for: military sci-fi or hard SF, or anything with biblical “character wakes up in purgatory/heaven/hell” narratives. The right comedic fantasy has yet to hit his inbox, but please don’t comp Douglas Adams or Sir Terry. John would like you to submit a covering letter, 1-2 page synopsis and the first three chapters (or 5,000 words whichever is longest) of your manuscript in a single word document. (In addition to the paid sessions, John 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 10th March 2025