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The University Foundation Programme (UFP) is a one-year intensive course that prepares both British and international students to attend top UK universities.
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
This training is designed for lawyers and covers key topics to ensure compliance with the Specialist Quality Mark (SQM) and other regulations.
QA Level 2 Award In Principles Of COSHH (RQF) Face to Face: Half-day course Virtual Classroom: Spread over 2 sessions of 2½ hr duration COSHH: Control of Substances Hazardous to Health Regulations 2002 Hazardous substances are everywhere, and COSHH assessments have to be undertaken in all businesses Run in an engaging and interactive way - see the video below Course Contents: Legal requirements relating to hazardous substances in the workplace Employer duties Employee duties Consequences of non-compliance Communicating safety information The different forms that hazardous substances can take Effects that may arise after exposure to hazardous substances The different routes that hazardous substances can enter the body How risk assessments reduce accidents and ill health at work The five step process of risk assessment The control hierarchy in relation to the safe use, handling, transporting, storage and disposal of substances hazardous to health Information to refer to when identifying and using hazardous substances Procedures for dealing with an incident involving hazardous substances Benefits of this course: COSHH stands for the 'Control of Substances Hazardous to Health' and falls under the Control of Substances Hazardous to Health Regulations 2002 This half day course is for all those who work, or wish to work, in a workplace that works with hazardous substances, such as in healthcare, in the manufacturing sector, cleaners, transport, utilities and even office environments Hazardous substances are everywhere, and COSHH assessments have to be undertaken in all businesses Candidates will learn about the legal requirements relating to hazardous substances, how risk assessments contribute to the safe use of hazardous substances, as well as the precautions and procedures required to ensure that the risks associated with hazardous substances are properly controlled Accredited, Ofqual regulated qualification: This QA Level 2 Award in Principles of COSHH (RQF) Course is a nationally recognised, Ofqual regulated qualification accredited by Qualsafe Awards.This means that you can be rest assured that your Principles of COSHH Certificate fulfills the legal requirements and is a very good way to make sure you and your employees are trained appropriately.The Ofqual Register number for this course is 603/0775/4