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
Registration starts at 7:30 AM. The training will begin promptly at 8:00 AM. Please plan your arrival accordingly to ensure you don't miss any important information. Reduce Emissions, Save Costs, Earn a CPC Hours, and Ensure Full Compliance Topics Covered: FORS Lo-CITY Driver Training (3.5 hours): • Relationship between driving style, fuel consumption, and environmental impact • Benefits of regular vehicle maintenance and checks • Fuel-efficient driving techniques • Utilising in-vehicle technology for fuel economy • Benefits of journey planning • Alternative fuels for commercial vehicles Highway Code Training Content: Course introduction, objectives, and expectations. Introduction to the Highway Code and its relevance. Types of road users and training for various groups. Respecting and understanding the risks to different road user categories. Confirmation of knowledge quizzes covering all aspects of the Highway Code and traffic regulations. Course Details: Format: Remote Session (7 hours) CPC Hours: Yes Cost: £89.50 - Includes course fee, Driver CPC Upload fee, VAT This award-winning program (awarded the prestigious Education in Transport award at the 2017 National Courier Awards) is perfect for any fleet operator looking to: Meet FORS Gold accreditation requirements. Improve driver performance and fuel efficiency. Reduce their environmental footprint. Enhance corporate social responsibility. Please note that this course is delivered online and provides 7 hours of Driver CPC training. Ready to get started? Book online or feel free to contact our training department at training@totalcompliance.co.uk or call 0345 9001312 to register for this valuable course. Please review our Terms and Conditions for more information.
Registration starts at 7:30 AM. The training will begin promptly at 8:00 AM. Please plan your arrival accordingly to ensure you don't miss any important information. Reduce Emissions, Save Costs, Earn a CPC Hours, and Ensure Full Compliance Topics Covered: FORS Lo-CITY Driver Training (3.5 hours): • Relationship between driving style, fuel consumption, and environmental impact • Benefits of regular vehicle maintenance and checks • Fuel-efficient driving techniques • Utilising in-vehicle technology for fuel economy • Benefits of journey planning • Alternative fuels for commercial vehicles Highway Code Training Content: Course introduction, objectives, and expectations. Introduction to the Highway Code and its relevance. Types of road users and training for various groups. Respecting and understanding the risks to different road user categories. Confirmation of knowledge quizzes covering all aspects of the Highway Code and traffic regulations. Course Details: Format: Remote Session (7 hours) CPC Hours: Yes Cost: £89.50 - Includes course fee, Driver CPC Upload fee, VAT This award-winning program (awarded the prestigious Education in Transport award at the 2017 National Courier Awards) is perfect for any fleet operator looking to: Meet FORS Gold accreditation requirements. Improve driver performance and fuel efficiency. Reduce their environmental footprint. Enhance corporate social responsibility. Please note that this course is delivered online and provides 7 hours of Driver CPC training. Ready to get started? Book online or feel free to contact our training department at training@totalcompliance.co.uk or call 0345 9001312 to register for this valuable course. Please review our Terms and Conditions for more information.
Save the date! 'Unlock the POWER of Sustainability' online training seminar on 30 January 2024 at 9:30am (GMT). Mark the date and tim 🌿Unlock The Power of Sustainability: Online Seminar for Your Business Teams🌿 Book your place and join us on Tue Jan 30 2024 at 09:30:00 GMT (Greenwich Mean Time) for this seminar to help you and your teams embrace sustainability with confidence for maximum business benefits. This 90-minute sustainability training course will cover: ✅Fundamentals of sustainability and what it means for businesses ✅Myths about sustainability and 'Net Zero' that will hinder your progress ✅Practical actions to integrate sustainability into your business strategy ✅How to align sustainability with business priorities ✅Getting 'buy in' from employees across the business ✅Mistakes to avoid in transitioning from talk to tangible action Our masterclass goes beyond theory, learning about calculating carbon footprint in your business or even how many trees should be planted each year. Instead, we help employees, Directors and CEOs of limited companies and social enterprises to recognise that embracing sustainability isn't just about compliance! 🚀Learn how you too can take a purposeful and strategic approach to enhance competitiveness and turbo charge growth.🚀 Register now for this transformational seminar that will help you take action for immediate implementation! 🌿Don't miss this opportunity to future-proof your business and gain a competitive edge!🌿
About this Virtual Instructor Led Training (VILT) The Advanced Reservoir Engineering VILT course will address modern practical aspects of reservoir engineering during 5 half-days packed with lectures, virtual exercises, discussions and literature reviews. The participants' understanding of fundamental concepts and modern practical reservoir engineering methods will be deepened and a wide range of topics will be addressed. Topics covered The VILT course will emphasise reservoir engineering applications and include topics such as: Rock properties of clastic and carbonate reservoirs Reservoir characterisation Reservoir fluid behaviour Identification of main production mechanisms Design and analysis of well tests Production forecasting Application of Decline Curve Analysis in mature fields Detailed modeling of wells and reservoirs Water flooding Application of EOR methods Reserves and resource estimation Reservoir simulation approaches, model construction and well, aquifer and fluid modelling Development planning Uncertainty handling and scenario methods Depending on the background and requirements of the participants, some topics may be given more emphasis. Training Objectives In this VILT course, reservoir engineering methods will be addressed which are of use in the daily reservoir engineering practice. The focus will be on practical applicability. Use is made of practical and actual reservoir engineering problems and examples to illustrate relevant subjects. By attending this VILT course, participants will have a deeper knowledge of modern reservoir engineering practices for reservoir development and production, including the construction and use of reservoir models. Target Audience The VILT course is intended for experienced reservoir engineers with prior technical or engineering exposure to production activities. Petroleum engineers and geoscientists who require more than general knowledge of reservoir engineering will also find this course useful. Participants are invited but not obliged to bring a short presentation (max of 15 minutes) on a practical problem they encountered in their work. This will then be explained and discussed in the VILT class. A short test or quiz will be held at the end the VILT course. Training Methods This VILT course will be delivered online over 5 half-days. There will be 2 blocks of two hours per day, including lectures, discussion, quizzes and short classroom exercises. Additionally, some self-study will be required. Two breaks of 10 minutes will be provided each day. Course Duration: 5 half-day sessions, 4 hours per session (20 hours in total). Trainer Your course leader is an independent Reservoir Engineering Consultant. He provides project consultancy, quality assurance and reservoir engineering training for major oil companies, governments, engineering firms and other global customers. Before he retired from Shell in 2012, he held positions as Senior Reserves Consultant for the Middle East and Reservoir Engineering Discipline Lead. He is a petroleum engineering professional, with global experience, mostly in Shell companies and joint ventures (NAM, SSB, SCL, PDO, SKDBV). He has been involved in reserves and resource management, has extensive reservoir modelling and reservoir simulation expertise, and wide experience in the design and delivery of training programmes for employee development. PROFESSIONAL EXPERIENCE 2012 - 2016 Independent Reservoir Engineering Consultant Project consultancy, quality assurance and reservoir engineering training for major oil companies, governments, engineering firms and other global customers. Delivering specialised and general Reservoir Engineering courses to a multitude of international companies. 2008 - 2012 Shell International E&P, the Hague, the Netherlands Senior Reserves Consultant for the Middle East Region Assurance of SEC and SPE compliance of reserves and resources in Shell Middle East region. Contributor to the 2012 SPE guidelines on reserves and resources assessment. 2006 - 2008 Shell E&P Technology Solutions, Rijswijk, the Netherlands Reservoir Engineering Discipline Lead Responsible for QA/QC of Reservoir Engineering in global E&P projects as well as for staff development. (over 60 international Reservoir Engineers) 2001 - 2005 Centre for Carbonate Studies, SQU, Oman / Shell International E&P Technology Applications and Research /Shell Representative Office Oman Petroleum Engineering Manager PE manager in the Carbonate Research centre, at Sultan Qaboos University in Oman. Industrial research projects and support to teaching on recovery aspects of carbonate reservoir development. Design and delivery of industrial courses on carbonate reservoirs 1997- 2000 Shell International E&P, Rijswijk, the Netherlands Principal Reservoir engineer. Acting Shell Group Reserves Co-ordinator in 1997-1998. Facilitation of workshops with government shareholders, including discussions on sensitive reserves issues (BSP Petroleum Unit Brunei, PDO Oman, SPDC government Nigeria). Co-ordination of the NOV subsurface team in Shell Kazakhstan Development BV in 2000. Leading role in Shell Gamechanger project on natural gas hydrates. 1992- 1996 Shell Training Centre, Noordwijkerhout, the Netherlands Reservoir Engineering Programme Training Director Directed Shell Group Reservoir Engineering Training. Introduced advanced PE training events, QA/QC and learning transfer measures, Design and delivery of reservoir engineering and multidiscipline courses to Shell staff from a wide range of nationalities. 1985- 1992 Shell International, SIPM, the Hague, The Netherlands Senior Reservoir Engineer Full field reservoir simulation projects supporting Field Development Plans, operational strategies and unitisation negotiations for Shell Group Operating Companies in the United Kingdom, New Zealand and Egypt. Major contributor to the Shell internal Gas Field Planning Tool development. 1984- 1985 Geological Survey of the Netherlands (RGD), Ministry of Economic Affairs Reservoir Engineering Section Head Responsible for Petroleum Engineering advice on oil and gas licences to the Ministry of Economic Affairs. First-hand experience with a government view on resource management. 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 about post training coaching support and fees applicable for this. Accreditions And Affliations
This must-attend masterclass will provide a comprehensive understanding of all the key developments in the latest statutory and non-statutory guidance documents from a DSLs perspective, and how they relate to safeguarding provision in schools and colleges.
About this Training Course This intensive 5 full-day has been designed as a separately bookable course comprising 3 days of Well Integrity (Basic) and 2 days of Advanced Well Integrity. The intensive 3 full-day course will equip the participants with a thorough knowledge of well integrity management and risk assessment in producing assets. Based on the regulatory requirements and using real examples and exercises from around the world, this represents best practice integrity management within the oil and gas industry. When to take action with a well is a critical decision, both from a safety and economic perspective. A consistent approach to decision-making provides certainty within the organisation, focusing effort, and spending wisely. The decision-making steps will be set out to ensure all critical aspects are captured consistently. Risk analysis approaches used by different organisations and examples of risk management and risk-ranking methods will be discussed. The 2 full-day course will deepen the participants' knowledge of well integrity management, and skills for designing, operating, and maintaining well equipment. The ultimate goal is to optimise productivity at the lowest Unit Operating Cost (UOC) and to maintain mechanical integrity throughout well life cycle. Well Integrity management is looked at in three distinct stages. The first stage is during the well design which includes material selection, engineering design, cement design, coating and inhibitors and cathodic protection. The second stage is monitoring the well during the life of the well, locating possible leaks and / or loss of metal. The last stage is to manage and control any well integrity issues using specialised products, services and techniques. Training Objectives 1. Well Integrity Training: Upon completion of this course, the participants will be able to: Define the building blocks of a successful well integrity management system Develop an approach to risk management, understand risk analysis and methods applied across the industry How do we 'Make Wells Safer', learn about emerging technologies for well integrity problem diagnosis and new techniques available to 'repair' the issues Execute the basic elements of well integrity management training for field operators Evaluate well design elements that enhance or hinder well integrity status definition during the operating phase of the well life-cycle Gain the demonstrable benefits of well integrity management from field experience Review cases studies and discuss them to enhance knowledge and take on board lessons learned 2. Advanced Well Integrity: Define well integrity well categorization based on compliance to the barrier policy outlined in the regulations and develop an approach to risk management Discuss well-completion design and construction to create a 'integer' well with the lowest life cycle maintenance cost from a WIM perspective Monitoring and surveillance of well integrity, focusing on barrier competence such as cementing and corrosion Investigate and manage well integrity issues, causes & potential solutions Understand repairs needed to address 'Loss of Well Operating Envelope' Gain an overview understanding of Well Suspension & Well Abandonment Discuss further case studies as well as conduct a post course test Target Audience Invaluable for production, operations, and integrity professionals involved in implementing & managing well integrity and seeking to improve performance. It is also essential for those who need to develop and implement such systems, or who have a general need to know and understand more about well integrity management. The course will also provide a fresh approach for senior professionals and managers. Designed for professionals in the oil and gas industry who are involved in the design, construction and operation of wells from the following disciplines: Production Maintenance Production Operations Drilling Engineering Safety engineering Well Intervention Well Integrity Engineering Asset Management Course Level Intermediate Advanced Trainer Gordon Duncan has over 40 years of experience in the Oil & Gas industry. During that time, he has worked exclusively in well intervention and completions. After a number of years working for intervention service companies (completions, slickline & workovers), he joined Shell as a well service supervisor. He was responsible for the day-to-day supervision of all well intervention work on Shell's Persian/Arabian Gulf platforms. This included completion running, coil tubing, e-line, slickline, hydraulic workovers, well testing and stimulation operations. An office-based role as a senior well engineer followed. He was responsible for planning, programming and organising of all the well engineering and intervention work on a number of fields in the Middle East. He had a brief spell as a Site Representative for Santos in Australia before joining Petro-Canada as Completions Superintendent in Syria, then moved to Australia as Completions Operations Superintendent for Santos, before returning to Shell as Field Supervisor Completions and Well Interventions in Iraq where he carried out the first ever formal abandonment of a well in the Majnoon Field. While working on rotation, he regularly taught Completion Practices, Well Intervention, Well Integrity and Reporting & Planning courses all over the world. In 2014, he started to focus 100% on training and became the Technical Director for PetroEDGE. Since commencing delivering training courses in 2008, he has taught over 300 courses in 31 cities in 16 countries to in excess of 3,500 participants. 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