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
Our Central Venous Access Device Training course is facilitated by registered clinicians with extensive experience.
Overcome the Fear of Public Speaking Are you held back by the fear of public speaking? This fear is more than just meeting nerves—it acts as a formidable barrier, muting your valuable contributions and stalling your career progression. Despite possessing valuable experience and ideas, the overwhelming fear of speaking out in meetings causes you to retreat into silence. Meanwhile, your less experienced but more confident colleagues speak up, gaining visibility and opportunities that could have been yours. A fear of public speaking is a significant obstacle blocking you from the recognition and career advancement you deserve. The Way Forward? Our Public Speaking Class in London is crafted for professionals keen to conquer their fear of public speaking and seize control of their careers. Embark on this transformative journey with us and swiftly gain the confidence to: Confidently share your thoughts and ideas in meetings - Actively engage in discussions - Deliver compelling presentations - Elevate your professional visibility Why Our Public Speaking Class in London? We understand your struggle. Our instructors have personally faced and overcome their own intense public speaking fears. Their journey has equipped them with the unique empathy and expertise to facilitate your journey from fear to confidence. Stop letting a fear of public speaking hold back your career. Join our Public Speaking Class in London and transform your next meeting into a confident opportunity for success. It's time for your voice to unlock the recognition and opportunities for your career success.
A photography workshop on how to use shutter speed creatively, including night photography and light trails. Workshop takes place in Central London.
The Level 2 Door Supervisor course is an accredited qualification that has been developed to meet the requirements of the Security Industry Authority (SIA). It is based on the relevant SIA Specifications for Learning and Qualifications and provides the necessary skills and knowledge for those who wish to apply for an SIA licence and work as a Door Supervisor in Licensed and other venues.
These topics are available as individual sessions or we can deliver all three as a full day’s training for Registered Practitioners. Facilitated by registered clinicians with extensive experience.
Data Ethics for Business Professionals is designed for individuals who are seeking to demonstrate an understanding of the ethical uses of data in business settings.
A lively night of hot Swing music and dancing including beginners and intermediate Lindy Hop classes brought to you by SwingdanceUK featuring live music! Where history is made! Kick off the evening with a Lindy Hop Swing dance class then dance to live music and DJs Simon 'Mr Kicks' Selmon and guests!
A wildlife photography workshop in Richmond Park, where you will learn how to capture beautiful wildlife photos in front of the majestic Red and Fallow Deer.