8232 Courses delivered Online

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 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 17 Points Development Level Develop

Study flexibly online with NMA for a BSc (Hons) Motorsport Engineering and open the door to an exciting career in motorsport. Study around work and family and choose your own start date. This course will teach you the specialist skills required by this competitive global industry.

Formation officielle BRCGS Food v9 (Norme Mondiale pour la Sécurité des Denrées Alimentaires version 9) pour les Auditeurs en français. Dispensée en ligne (Zoom) en direct par un partenaire de formation agréé BRCGS. Frais d'examen et de certificat inclus dans le prix.

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

LOOKING FOR: YA, ADULT FICTION, NON-FICTION Laura Williams is literary agent at the Greene and Heaton Literary Agency. She is seeking literary fiction, commercial fiction, psychological thrillers and high concept Young Adult. Laura is actively building a fiction list and a small non-fiction list. She is currently looking for literary fiction, edgy commercial fiction, psychological thrillers and high-concept contemporary young adult, as well as narrative non-fiction of all types. Her taste is quite dark, and she loves gothic, ghost stories, horror and anything sinister. She also loves books that make her cry, from big love stories to intense family dramas. She is open to historical or horror YA, but not magical or fantasy.  Meditative or moving novels about modern life, appeal to Laura, sad stories with love and the importance of caring for each other shining through. She also loves stories about female friendships or conversely groups of women who don't get on, such as the hugely fun BAD SUMMER PEOPLE by Emma Rosenblum. She is always on the lookout for a big tragic love story to make her cry happy or sad tears. At the more commercial end of fiction, think funny novels with warmth and romantic comedies with a bit of depth – think Marian Keyes. Most of all Laura is looking for novels she hasn’t read before – something unusual structurally or thematically, something that shines a light on a subject the author is passionate about, something that’ll break her heart or raise her blood in an entirely new way. Laura is always looking to promote diverse voices from across the globe, and is particularly keen on LGBTQI+ stories. Laura would like you to submit a covering letter, a 1-2 page synopsis and the first 5,000 words of your completed manuscript in a single word document. (In addition to the paid sessions, Laura 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 6th January 2025

Whether it is for your personal development, your own career or your business, this life-changing training is for everyone who would like to develop their skills such as communication, confidence, entrepreneurial thinking, flow-state and creativity – the future skills every human needs to master.

LOOKING FOR: MG, YA, ADULT FICTION, NON-FICTION Thérèse is a Literary and Rights Agent at Susanna Lea Associates, @SLALondon. Born and raised in Belgium, on a diet of frites and Tintin she moved to England in her late teens with her family, then stayed in London to do a History degree and Masters at University College London. Having been brought up bilingual, translation rights seemed like her logical next step. She started off in the rights department at Bloomsbury Publishing, before hopping across the square to Ed Victor’s agency, and found experiencing both the publishing and agency side of publishing incredibly valuable. She has been building her own list of authors alongside selling translation rights since early 2016, which she has hugely enjoyed; working with authors right from the book’s conception, while also experiencing the thrill of selling her own authors’ works in the UK and US as well as in translation to publishers across the globe. In terms of adult fiction, Thérèse has a huge soft spot for historical fiction, having read Early Modern History at university, but is also very much on the hunt for crime/thrillers, bookclub, high-concept love stories and literary fiction. She loves strong female characters, in particular when they go through an evolution or journey as the story progresses and gradually find that inner strength. On the children’s fiction front, Thérèse is all about finding a fresh, new voice. She loves all things funny, fantasy and adventure – across lands, time and space, and involving strong friendships and strong lead characters - and wants to be transported straight away when reading a manuscript. She likes very vivid, well-crafted and imaginative worlds, such as stories set in a toy factory or in an underwater world. Thérèse would love some more adventures set in space, mysteries, quirky characters, explorers and imaginary friends. And last, but not least, in non-fiction, history features heavily in her interests, but Thérèse would also love to see books about big ideas, culture, sociology, science, anthropology and memoir. Anything that helps expand the mind and questions or informs the way in which we view ourselves, the world and how we fit into it, all written in an engaging and accessible manner. Thérèse 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, Thérèse 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: Tuesday 7th January 2025

Official BRCGS Agents and Brokers Issue 3 for Sites course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Official BRCGS Agents and Brokers Issue 3 for Auditors course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Official BRCGS Storage & Distribution Issue 4: Sites course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.