About this training course This 5-day intensive training course is designed to improve the skills of those involved in the financial and contractual auditing of upstream Oil & Gas Exploration and Production activities. The objective of this course is to enhance your understanding of the various audit principles and practices being applied in this industry today and to equip you with the knowledge and tools to deal with complex audit cases. The course concentrates on aspects of auditing unique to the E&P business. Training Objectives After the completion of this training course, participants will be able to: Apply a structured methodology for conducting oil industry internal, production sharing and joint venture audits Implement the benefits of a multi-discipline team audit approach Adopt a model of best practice for conducting audits Analyse, interpret and decide complex cases using the contracts and documents, the principles and auditor's judgement Target Audience This training course is suitable and will greatly benefit the following specific groups: Personnel with an Internal audit background who are totally new to the discipline of Joint Venture (JV) or Production Sharing Contract (PSC) audit Experienced audit practitioners who wish to update their auditing techniques Personnel from Finance or any discipline who intend to take part in internal or joint venture audits Personnel with a background in statutory audit in the accountancy profession who require an insight into the internal and joint venture audit areas Course Level Intermediate Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 5 days in total (35 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training The maximum number of participants allowed for this training course is 25. Trainer Your expert course leader has more than 30 years of experience in the international oil and gas industry, covering all areas of Finance and Audit, including involvement in Commercial roles. During her 19 years with ENI she worked in Italy, Netherlands, Egypt and UK and was CFO for 2 major ENI subsidiaries. She has delivered training courses in Accounting, Audit, Economics and Commercial topics in many Countries. She has a Degree in Economics & Accounting and is a Certified Chartered Accountant. She is also a Chartered Auditor and an International Petroleum Negotiator. Outside of work, she is inspired by the beauty of nature and art, helping disadvantaged people, sports (football, golf) and her cat. Courses Delivered Internationally: E&P Accounting, Auditing in the Oil & Gas Industry Cost Control & Budgeting Introduction to the Oil & Gas Industry Petroleum Project Economics Contracts Strategy International O&G Exploitation Contracts POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
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