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
About this Virtual Instructor Led Training (VILT) This 4 half-day Virtual Instructor Led Training (VILT) course presents the principles and best practices of portfolio management in the upstream (E&P) oil and gas industry. The VILT course is equally valuable for small independents, large integrated international companies and national oil companies. The VILT course consists of presentations, case studies, illustrative practical exercises and syndicate discussions. Particular emphasis is given to pragmatic portfolio management approaches and solutions which can be implemented swiftly without recourse to major investments in planning and portfolio management software. The VILT course will draw on examples from your expert course leader's 35+ years' experience in the oil and gas industry as an explorationist, upstream vice-president and management consultant. The VILT course handout will comprise softcopy slides used in the presentation and a softcopy workbook for the exercises. Participants will gain proficiency in portfolio management techniques, understand how and why to undertake this activity and be able to apply key concepts directly in the business of their teams / divisions. The VILT course will be presented over 4 half-days, using Microsoft Teams or Zoom and a proprietary set of VILT tools. Participants will be asked to complete a pre course questionnaire (PCQ) addressing their objectives and experience, and attend a session to familiarise themselves with VILT tools before course commencement. Training Objectives To present the tools, concepts and principles of portfolio management To define the quantitative metrics which are used to describe projects in a portfolio To understand the benefits of portfolio management at different stages of the upstream business: in strategy development, opportunity screening, business development, drilling prospects, conducting appraisal of discoveries and developing fields To put portfolio management in the organisational context by describing the role of the portfolio management team and examining how value assurance (quality control) is best conducted on portfolio data for projects and assets To demonstrate how portfolio management contributes to improved business performance By the end of the VILT course, participants will understand: Key concepts and principles of portfolio management How to design a simple portfolio database and describe complex projects in a small number of objective metrics How to segment the portfolio into meaningful units How to use portfolio data in making business choices and decisions at the strategic and tactical levels The extent to which it is meaningful and reasonable to make comparisons across different portfolio segments How the portfolio management team can support the wider business in decision-making Target Audience This VILT course is specially designed for exploration and development geoscientists, E&P economists and finance staff, and E&P managers. Both technical and non-technical staff will benefit from the concepts presented. Companies are encouraged to send participants from different functions and seniority levels to gain great benefits especially those which would like to implement the concepts presented in this VILT course. Course Level Basic or Foundation Training Methods The VILT course will be delivered online in 4 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. The VILT course will be presented in an interactive workshop format that allows for discussion. Course Duration: 4 half-day sessions, 4 hours per session (16 hours in total). Trainer Your expert course leader draws on more than 35 years of experience managing, reviewing and directing projects in all aspects of the exploration business: from exploration business development (new ventures), through prospect maturation and drilling, to the appraisal of discoveries. He has more than 30 years' experience with Shell International, followed by 10 years consulting to NOCs in Asia Pacific, Africa and South America and independent oil companies in the United Kingdom, continental Europe and North America. Other than delivering industry training, he has worked on projects for oil & gas companies of all sizes, including independents, national oil companies and (super)-majors, private equity firms, hedge funds and investment banks, and leading management consulting firms. He is an alumnus of Cambridge University. He has M.A and Ph.D. degrees in geology and is a Fellow of the Geological Society of London as well as a respected speaker on management panels at international conferences. Professional Experience Management consultancy & executive education: Advice to investment banks, businesses and major consulting firms. Specialist expertise in upstream oil & gas, with in depth experience in exploration strategy, portfolio valuation and risk assessment. Leadership: Managed and led teams and departments ranging from 3 - 60 in size. Provided technical leadership to a cadre of 800 explorationists in Shell worldwide. Member of the 12-person VP team leading global exploration in Shell, a $3 bln p.a. business and recognised as the most effective and successful among its industry peers. Accountability & decision-making: Accountable for bottom-line results: in a range of successful exploration ventures with budgets ranging from $10's million to $100's million. Made, or contributed to, complex business decisions / investments, taking into account strategic, technical, commercial, organisational and political considerations. Corporate governance: Served as non-executive director on the Boards of the South Rub al Khali Company (oversight of gas exploration studies and drilling in Saudi Arabia) and SEAPOS B.V. (exploration deep-water drilling and facilities management). Technical & operations: Skilled in exploration opportunity evaluation, the technical de risking of prospects, portfolio analysis and managing the interface between exploration and well engineering activities. Unparalleled knowledge of the oil and gas basins of the world, and of different operating regimes and contractual structures, ranging from Alaska, Gulf of Mexico and Brazil, through to the Middle East, former Soviet Union, Far East and Australia. Safety: Following an unsatisfactory audit, became accountable for safety performance in Shell's exploration new ventures. Through personal advocacy and leadership of a small team, delivered pragmatic and effective HSE systems, tools and staff training / engagement and a dramatically improved safety record. R&D: Experience in the 3 key roles in R&D: scientific researcher, research manager, and 'customer' for R&D products. After re-defining Shell's exploration R&D strategy, led the re-structuring of the R&D organization, its interface with 'the business' and approaches to deployment and commercialization. Strategy: Accomplished at formulating competitive strategies in business, R&D and technology deployment, translating them into actionable tactics and results. Defined the exploration strategy of PDO (a Shell subsidiary in Oman) and latterly of Shell's global exploration programme. Professional education, behavioural/motivational coaching: Experienced in organisational re-design, change management, leadership education and talent development. Commercial skills: Personally negotiated drilling compensation claims, educational contracts and E&P contracts, with values of $5 million to $100+ million. 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
Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com
Enhance your ear assessment and care skills with our comprehensive course on ear irrigation. Gain practical knowledge and updated insights for optimal ear hygiene.
Gain essential knowledge and practical skills to provide effective care for patients with stomas with our "An Understanding of Stoma Care" course. Learn how to maintain stoma health and support patients through their journey.
ADVANCED 8 CPD POINTS 1 DAY INTENSIVE COURSE ONLINE or IN-CLINIC NOTE! After booking we will contact you for scheduling the exact course date! Courses dates are subject to change due to mentors availability. We will inform you via email if a date becomes available! This course theory will help you to understand: We will cover all you need to know in order for you to treat your patients confidently and safely. The Theory will cover; Anatomy and physiology Ageing Characteristic of the ideal skin booster Product Introduction Treatment Method Contraindication Complication management Pre & Post-treatment advices Using Products like Toskani, Skinecos, Jalupro etc. Using Products , PROFHILO, recommended for midd and low part of the face as well as other delicate areas of skin such as the neck, décolletage, hands or knees. Practice will enable you to learn in 1-day ONE-TO-ONE Training We will cover pertinent information including mechanism of action, safety and efficacy issues, management and treatment of complications, dilution guidelines, and more. A certification of hands-on training will be provided upon completion of the course. You will perform this procedure on live models injecting superficially and administrating the product (skinbooster) into the subcutaneous layer. This will happen under the supervision and guidance of highly experienced aesthetic practitioners. You will practice injectables with needle on; Face, Neck, Decolatege & Hands You need to be medically qualified as a doctor, dentist, nurse, pharmacist or paramedic with full governing body registration and have completed a Foundation Filler Course and to have administered a number of cases. Additional information ATTENDANCE ONLINE (Theory), IN CLINIC (Practice) COURSE LEVEL INTERMEDIATE | Advanced Course
Intercultural Competence: In-House Training In a world that conducts business across continents and geographical borders, more than ever it is essential for team and organizational leaders to not only understand but also embrace the diversity of cultures; this is intercultural competence. Intercultural competence gives one the ability to effectively and appropriately communicate with people from other cultures in a competitively complex world. The participant in this program will gain cultural insights needed to build intercultural teams and navigate cultural diversities, without knowingly violating what are deemed to be acceptable or unacceptable cultural norms. What you will Learn At the end of this program, you will be able to: Articulate on the meaning of culture and intercultural competence Express the importance of body language and appropriately demonstrate its emblems Describe three cultural models and consider their application in assimilating cultural behaviors Define emotional intelligence and explain how it is linked to cultural intelligence Examine the four cultural intelligence capabilities and give examples of how each is developed Develop a personal cultural profile and compare its dimensions to gain an appreciation for intercultural competence Foundation Concepts Fundamentals of culture Culture and body language Culture and proxemics Cultural Models Iceberg culture model The onion model of culture Hofstede's model of national cultures High-context and low-context cultures Cultural Intelligence Emotional intelligence overview Cultural intelligence overview Cultural Profile Cultural profile dimensions Understanding your cultural profile
Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com
In this class you will learn the Yang 10-Step Tai Chi Form. This is a 'standardised' routine, in other words it is performed in the same way throughout the world. We are also doing a set of Qigong exercises for the health of the internal organs. This is a 13-week term.
Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com