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
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Course Information Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. This course will assist delegates with: A practical approach for the development and conduct of process and system audits An enhanced understanding of key system audit principles, preparation, design and conduct Increased expertise, efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Share knowledge and experiences. By the end of the course delegates will be better able to: Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation Improve the effectiveness, focus and credibility of the audit programme Understand the key system audit principles, preparation, design and conduct Develop system audit tools to ensure more effective audit conduct and outcome Create audit strategies utilising risk management principles Prepare for inspections. Tutors Tutors will be comprised of (click the photos for biographies): Allison Jack Executive Director, Bristol Myers Squibb Rocio Castellanos Director, Pfizer Ltd Guy Houben G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. 09:30 Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 Break 10:35 Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 Designing System Audit Tools 12:45 Lunch 13:30 System Audit Plan - Exercise 14:00 Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. 14:15 Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 Break 15:20 Case Studies - Session 1 continued 16:30 Case Studies - Feedback 17:00 Close of Day 1 Day 2 09:00 Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. 09:10 Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. 10:30 Break 10:45 A Simple System Audit Example - Case Study Feedback 11:30 Strategy Audit programme planning. 12:15 Lunch 13:00 Case Studies - Session 3 Work on delegate's case studies. 14:30 Break 14:45 Case Studies - Session 3 - Feedback 15:15 Closing remarks 15:30 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 14 Points Development Level Develop
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