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
Formation officielle Auditeur Principal (Lead Auditor) BRCGS Food v9 (Norme Mondiale pour la Sécurité des Denrées Alimentaires version 9) 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.
DGSA training
Level 3 Award in Education and Training. Become a qualified Trainer.
Our comprehensive online course offers a deep dive into Urban and Rural Driving and Manual Handling. Whether you're a seasoned driver or just starting out, this training will equip you with essential knowledge and skills to navigate various road conditions safely and efficiently. Manual Handling Training Content: Course introduction, objectives, and expectations. Navigating urban and rural environments. Recognising road signs, hazards, and protecting vulnerable road users. Route planning, stress management, and safe driving practices. Safe Loading of Vehicles: Acquire essential knowledge and practical skills for securing loads effectively, preventing accidents, and complying with road safety regulations. Invest in your professional development and become a safer, more compliant driver.
An introduction course is a great way to learn about the amazing craft of blacksmithing, the course will teach you the basics of forging and making decorative work for your home and you will have something you have made to take home with you and enjoy. On the course we will make a twisted and scrolled fire poker and a hook to hang it, if we have time we may also make another small item such as a bottle opener or key ring Courses are £150 Per person per day I run a strict cancellation policy. If you cannot attend the date you have booked please contact me within three weeks and I will rebook your course for free, If you contact me after this deadline you will lose your place. Refunds are not available. No under 18s If you have a physical gift voucher it must be presented on the first day of a course. *Gift vouchers are valid for one year from date of purchase
The MA Learning & Teaching in Creative Industries is perfect if you’re looking to enter into a teaching career for the first time. It’s also the ideal choice if you’re an experienced educator wanting to broaden your knowledge and skills within the field of creative arts education at Further Education and Higher Education levels. You’ll engage in critical and collaborative development as a creative educator and improve your skills and agency as a teacher, as well as literacy in educational research.
Are you passionate about the business side of film? Do you have an entrepreneurial mindset and ambitions to pave a career in a fast-growing creative industry? The BA (Hons) Film Business & Production degree reflects current demands for professionally ready graduates equipped with the vital creative, business and entrepreneurial skills to navigate the modern film, screen and media environment.