The Trisat 3 day RTACC course is a QNUK qualification course delivered by CTR Secure Services who have over 24 years operational experience within the close protection and medical sectors.
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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ISO 7101 Healthcare Quality Management System Lead Auditor Course provides participants with the knowledge and skills necessary to lead audits of quality management systems within healthcare organizations. This comprehensive training program covers the principles, processes, and practices of auditing healthcare quality management systems, focusing on key standards and regulations applicable to the healthcare industry.
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Better Business Cases™ Practitioner Better Business Cases™ is based on the Five Case Model - which is the UK government's best practice approach to structuring spending proposals and making effective business decisions. Using this best-practice approach will allow organizations to reduce unnecessary spending and improve the decision-making process which gives you a greater chance of securing necessary funding and support for initiatives. The goal of the practitioner course is to develop a candidate's ability to deliver a comprehensive business case, through encouraging expanded knowledge to guide the practical application of theoretical foundations. Upon the completion of this Practitioner course, a candidate will be able to start applying the model to a real business case development project. What You Will Learn At the end of this program, you will be able to: Develop the lifecycle of a business case and to establish the relationships between the five cases Apply the steps in the business case development framework, in order to support the production of a business case, using the Five Case Model, for a given scenario Overview of Better Business Cases Alignment with the strategic planning process Importance of the Business Case using the Five Case Model Overview of the Five Case Model Purpose of the key stages in the development of a spending proposal Purpose of a Business Justification Case Business Case Development Process Purpose of project / programme assurance and assurance reviews Responsibility for producing the Business Case Determining the Strategic Context and Undertaking the Strategic Assessment Scoping the Scheme and Preparing the Strategic Outline Case Planning the Scheme and Preparing the Outline Business Case Procuring the Solution and Preparing the Full Business Case Implementation and monitoring Evaluation and feedback Making the Case for Change Agree on the strategic context Determine spending objectives, existing arrangements, and business needs Determine potential business scope and key service requirements Determine benefits, risks, constraint, and dependencies Exploring the Preferred Way Forward Agree on critical success factors Determine long list options and SWOT analysis Recommend a preferred way forward Determining Potential Value for Money Revisit the short list Prepare the economic appraisal for short-listed options Undertake benefits appraisal Undertake risk appraisal Select preferred option and undertake sensitivity analysis Preparing for the Potential Deal Determine the procurement strategy Determine service streams and required outputs Outline potential risk apportionment Outline potential payment mechanisms Ascertain contractual issues and accountancy treatment Ascertaining Affordability and Funding Requirement Prepare the financial model Prepare the financial appraisals Planning for Successful Delivery Plan programme / project management Plan change and contract management Plan benefits realization Plan risk management Plan programme / project assurance and post project evaluation Procuring the Value for Money Solution Revisit the case for change Revisit the OBC options Detail procurement process and evaluation of best and final offers (BAFOs) Contracting for the Deal Set out the negotiated deal and contractual arrangements Set out the financial implications of the deal Ensuring Successful Delivery Finalize project management arrangements and plans Finalize change management arrangements and plans Finalize benefits realization arrangements and plans Finalize risk management arrangements and plans Finalize contract management arrangements and plans Finalize post-project evaluation arrangements and plans