99 Auditor courses delivered Live Online

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

Overview An ineffective audit can mean severe consequences; resulting in process failure, customer dissatisfaction and regulatory noncompliance. Optimize your generic auditing skills with this Internal Auditing training course not aimed at any specific ISO management systems standard or Process. Boost your internal audit capabilities by gaining confidence in planning and performing an effective audit and reporting and taking corrective action where necessary. This course develops the necessary skills to assess and report on the conformance and implementation of processes based on management systems. You'll learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities

Overview The development, monitoring, and continued improvement of a highly-integrated, internal audit function is essential for the continued financial success, stability, and growth of world-class business entities. A well-designed and effective internal audit system will provide verification and support that accounting and financial policies, procedures, and controls are working adequately and will spotlight any significant matters that need attention. 

Overview Internal control, as defined by accounting and auditing, is a process for assuring an organization's objectives in operational effectiveness and efficiency, reliable financial reporting, and compliance with laws, regulations and policies. It is very important for the organisation to have a smooth flow of accounting as it plays a very important role in the development of the organisation. Financial Managers or any person who deals with Accounts need to see that the company accounts are very updated and are free from any risks that can become a problem during the time of Auditing.  This course will feed you with all the skills required to have a good Internal Management process it is important to analyse Risk Management to see if the process is working efficiently and measures the effectiveness of controls put in place to alleviate risks. 

Overview This training course will empower you to recognize the root causes of fraud and white-collar crime in the current economy, understand the categories of fraud, equip you with methodologies of fraud detection and prevention, and heighten your ability to detect potential fraudulent situations. In addition to the fundamentals of fraud investigation and detection in a digital environment; profit-loss evaluation, analysis of accounting books, legal concepts, and quantification of financial damages are also examined in this course

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.

Official BRCGS Packaging Sites Conversion Issue 7 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Certified Business Analysis Professional™ (CBAP®) Boot Camp: In-House Training The course provides targeted exam preparation support for IIBA® Level 3 - CBAP® exam candidates, including both a BABOK® Guide Version 3.0 content review and exam preparation tutorial. The class is interactive, combining discussion, application of concepts, study tips, and a practice exam. Knowledge Check quizzes and self-assessments allow candidates to identify areas of weakness and create a custom study plan tailored to their individual needs as well as study aids to support their exam preparation after the course. The course materials include a copy of A Guide to the Business Analysis Body of Knowledge® (BABOK® Guide) Version 3.0. What you will Learn Upon completion, participants will be able to: Demonstrate familiarity with the structure and content of the IIBA® BABOK® Guide Improve their probability of passing the Level 3 - CBAP® Exam Identify their knowledge gaps through the use of module Knowledge Check quizzes Gauge their readiness for taking the exam by IIBA® BABOK® Guide Knowledge Are Foundation Concepts for IIBA® CBAP® Prep IIBA® - the Organization Business Analysis - the Profession Knowledge Check Terminology and Key Concepts IIBA®'s BABOK® Guide - the Standard Underlying Competencies BA Techniques Business Analysis Planning and Monitoring Knowledge Check Overview BAP&M Tasks BAP&M Techniques Elicitation and Collaboration Knowledge Check Overview E&C Tasks E&C Techniques Requirements Life Cycle Management Knowledge Check Overview RLCM Tasks RLCM Techniques Strategy Analysis Knowledge Check Overview SA Tasks SA Techniques Requirements Analysis and Design Definition Knowledge Check Overview RA&DD Tasks RA&DD Techniques Solution Evaluation Knowledge Check Overview SE Tasks SE Techniques Exam Preparation Practice Exam and debrief Exam Preparation Study Tips Manage Study Plan Exam Process Exam day

Root Cause Analysis (RCA) is used to analyse the root causes of focus events with both positive and negative outcomes, but it is most commonly used for the analysis of failures and incidents. Causes for such events can be varied in nature, including design processes and techniques, organizational characteristics, human aspects and external events. RCA can be used for investigating the causes of non-conformances in quality (and other) management systems as well as for failure analysis, for example in maintenance or equipment testing.

Formation officielle BRCGS Food v9 (Norme Mondiale pour la Sécurité des Denrées Alimentaires version 9) pour les Auditeurs 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.