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
Duration 1 Days 6 CPD hours This course is intended for This course is intended for individuals who want to become more rational and disciplined thinkers. Overview Upon successful completion of this course, students will boost their performance with an increase in their decision-making ability. In this course, students will learn develop their ability to analyze and evaluate information. 1 - GETTING STARTED Icebreaker Housekeeping Items The Parking Lot Workshop Objectives 2 - COMPONENTS OF CRITICAL THINKING Applying Reason Open Mindedness Analysis Logic Case Study 3 - NON-LINEAR THINKING Step Out of Your Comfort Zone Don't Jump to Conclusions Expect and Initiate Change Being Ready to Adapt Case Study 4 - LOGICAL THINKING Ask the Right Questions Organize the Data Evaluate the Information Draw Conclusions Case Study 5 - CRITICAL THINKERS (I) Active Listening Be Curious Be Disciplined Be Humble Case Study 6 - CRITICAL THINKERS (II) Seeing the Big Picture Objectivity Using Your Emotions Being Self-Aware Case Study 7 - EVALUATE INFORMATION Making Assumptions Watch out for Bias Ask Clarifying Questions SWOT Analysis Case Study 8 - BENEFITS OF CRITICAL THINKING Being More Persuasive Better Communication Better Problem Solving Increased Emotional Intelligence Case Study 9 - CHANGING YOUR PERSPECTIVE Limitations of Your Point of View Considering Others Viewpoint Influences on Bias When New Information Arrives Case Study 10 - PROBLEM SOLVING Identify Inconsistencies Trust Your Instincts Asking Why? Evaluate the Solution(s) Case Study 11 - PUTTING IT ALL TOGETHER Retaining Your New Skills Reflect and Learn From Mistakes Always Ask Questions Practicing Critical Thinking Case Study 12 - WRAPPING UP Words from the Wise Review of Parking Lot Lessons Learned Completion of Action Plans and Evaluations
This can be introduced in one day but is better offered over a series of twilight or half day workshops with individualised coaching. We will provide background context for this approach and will directly model the process with real live issues facing participants. So bring your most challenging concerns to this training. Course Category Behaviour and Relationships Visioning and Problem Solving Team Building and Leadership Description ‘Insights and Solutions Circle’ a new expanded version of Solution Circle that uses some of the best of the Circle of Adults process. Its a 50 minute process and works really well with families and professionals! Contact us today for a live demo or training… Steps Problem presented Questions asked Theories Shared Strategies listed Dialogue regarding selected strategies Next steps Testimonials Excellent! It was great how we all cam up with ideas and theories including us parents I wish all meeting about my child’s behaviour were like this The whole world is going to be interested in this… The empowerment is great The buzz after the meeting says it all. Learning Objectives Deeper understanding of what is actually happening underneath the presenting behaviour Increased confidence in managing and building relationships with challenging pupils in mainstream schools Learn process for locating richer and wider range of practical strategies to impact on behaviour problems Deeper understanding of yourself and the psychodynamic processes happening between pupils, staff and pupils and families Opportunity to reflect on professional practice Mutual support established with other front line practitioners Who Is It For ? Team Around the Child agencies Parents and Professional working together Families Multi Agency Teams Social workers CAMHS teams Year Managers Primary and secondary staff teams Early Years and School based Practitioners Heads and Deputies SENCOs Advanced Skills Teachers Primary and secondary teachers Local Authority Support Services Course Content This can be introduced in one day but is better offered over a series of twilight or half day workshops with individualised coaching. We will provide background context for this approach and will directly model the process with real live issues facing participants. So bring your most challenging concerns to this training. The course answers the questions: Can we find an alternative to permanent exclusion or special unit or school placement? Cannot understand why a child is behaving as they do? Struggling with a child for whom praise is ineffective? Feeling isolated in your responses to a child’s needs? Worried about where your instinctive reactions are leading you? Cannot seem to get any consensus view of a young person’s behaviour/needs amongst all the family and professionals involved – is everyone pulling in different directions? We will cover: Setting the tone Background and detailed teaching of process Inclusion values underpinning this work Graphic and process facilitation skills Processes modelled and opportunities to try process out with coaching Practical setting up of insights and solutions circles Lessons learned If you liked this you may like: CIRCLES OF ADULTS…
The role of an MLRO is one of high responsibility, with financial and personal consequences if something goes wrong. As an MLRO or Deputy MLRO, you need the confidence and practical skills to tackle the unique challenges these roles present. Part of the ICA Practitioner Series, this unique certification is written by MLROs for MLROs and provides a practical framework and toolkit that gives you the knowledge and skills to: navigate the complex role of a Money Laundering Reporting Officer mitigate risks make changes and set goals challenge stakeholders make informed decisions and demonstrate the rationale manage relationships with boards and regulators effectively. This qualification covers the following topics: Interview questions and wider due diligence before taking up an MLRO / Deputy MLRO position Governance - senior management responsibilities - prescribed responsibilities Management information & report writing Risk assessment and risk appetite Policies, procedures & operational implementation Staff, training, leading and influencing/psychological models to develop interpersonal skills Quality of oversight - obtaining trusted data First 100 days - main risks and expectations Form A - FCA Registration, fit & proper interview Building Trust - stakeholder management, committees, management information, regulatory interaction, the MLRO Report Problem shooting and escalation pathways
Professional Management is crucial to your company's success. In fact, managers can have the single largest impact on your organisation's productivity and overall profitability, with more influence over employee morale and performance than anyone else.
Peer mediation is an approach to impacting on conflict resolution and bullying in primary and secondary schools by training pupils to be mediators or ‘counsellors’. This well proven, highly effective method of impacting on school based bullying is still viewed by some as radical. In this workshop participants are introduced to the key components of successful schemes. Our trainers have first hand experience of setting up school based schemes and sustaining these over time. Peer Mediation Training Guide Online Course now available via Teachable Platform – Peer Mediation Learn at your own pace… lots of text and video support Course Category Peer Support Description Peer mediation or peer counselling is an approach to impacting on bullying in primary and secondary schools by training pupils to be ‘Peer Mediators’ or ‘counsellors’. This well proven, highly effective method of impacting on school based bullying is still viewed by some as radical. We can provide training for staff or direct training with students across the age range – typically delivered over 6 short high impact, interactive learning workshops. For staff training, participants are introduced to the key components of successful schemes. Our trainers have first hand experience of setting up school based schemes and sustaining these over time. Enjoy participating in a multi media workshop that will challenge, entertain and reach for your emotions. Watch young people doing their stuff! Testimonials Thank you for the course – I really enjoyed it Learning Objectives To be able to understand the values and wider context of peer support To be able to set up and run a peer counselling scheme to reduce bullying To understand and be able to maximise the power of the peer group in supporting relationships, achievement and behaviour change Who Is It For ? Year 5 or Year 10 pupils Primary and secondary teachers Heads and Deputies SENCOs Learning Support and Guidance staff Advanced Skills Teachers Parents Local Authority Support Services Community Development workers Early Years and School based Practitioners Course Content The course answers the questions : What do you do with major bullying problems in school? Practically how do we go about recruiting and training pupils as counsellors? Will pupils be hurt if we involve them with bullies? Key Themes covered within the direct student training as well as in the staff development sessions- include: Issues of Confidentiality Welcoming your ‘client’ Using active listening skills Using Open and Closed Questions to enable your client to tell you his or her story How to reflect back feelings and how to check you have understood what the client has told you Exploring options for resolving the bullying issue with your client This video gives a brief taster of the work in a Nottingham Primary school. If you liked this course you may well like: PEER SUPPORT AS AN ANTI-BULLYING STRATEGY AT LOCAL AUTHORITY LEVEL
Preparing for the CISSP Certification Exam? Then this course is for you. In this course, you will learn more effective CISSP study techniques, exam hacks, formats, and strategies, as well as how to correctly respond to exam questions.
About this Training Course Well engineers who are responsible for technically evaluating and authorizing programs for drilling or working over wells must have the required skills and competencies to safely design wells of varying nature. They also need to be able to confirm that well delivery and intervention programs generate intrinsic well control assurance. Such work programs must establish, verify, monitor and maintain suitable and sufficient barriers for the entire well lifecycle - from spud to abandonment. Well engineers must also be able to select a suitable drilling or workover rig, capable of safely performing the work within its operational envelope. This 3 full-day course aims to further develop and assess the knowledge required to work on and eventually, authorize a well delivery program as deemed fit for purpose. It also addresses elements of well control that must be embedded into well design, well work programming and equipment selection. This course is intended for participants who already have a sound understanding of the principles of the design and/or delivery of wells and with more than 3 years of relevant industry experience. Training Objectives By the end of this course, participants will be able to: Feel confident to design and plan drilling and workover activities while considering geological risks, formation pressures/strengths, and any integrity or well control concerns. Monitor wells operations and ensure that they can and will remain within the accepted design envelope. Assess risks and then apply mitigation or recovery methods in cases where design envelopes are threatened. Participants should be capable of assessing a drilling or workover program and then be able to answer the following key questions: Does the program delivery have a sound design and work plan that allows the well(s) to be drilled or worked over safely? Have we determined the appropriate kick tolerance for each open hole section and is it realistic for all drilling hazards that may be encountered? Have all drilling hazards been suitably assessed, and the associated risk mitigated to a level as low as reasonably practicable? Are there adequate, verifiable barriers in place throughout the operation and does everybody know their role and responsibility? And, as applicable, is the selected rig capable of implementing the work program? Target Audience This course is intended for personnel directly or indirectly involved in the preparation, review or authorization of drilling and workover programs. This includes: Well engineers and drilling supervisors who are responsible for planning and executing drilling and workover operations. Contractor well engineers, rig managers and other senior drilling staff. Senior well engineers and rig superintendents who are responsible for managing the delivery of a project or well. Technical authority holders who are responsible for licensing drilling and workover operations from a regulatory perspective. Assessment: A satisfactory command of critical knowledge and skills is assured by a 1+ hour closed book assessment. This assessment has a mix of multiple-choice questions (MCQs), calculations and answers that must be written up. The exam is taken electronically. Participants are provided with a suitable formula sheet. The pass mark for issuing a certificate is 70% and participants who are not successful will be issued with a certificate of attendance instead. Trainer Your expert course leader has over 45 years of experience in the Oil & Gas industry. During that time, he has worked exclusively in the well engineering domain. After being employed in 1974 by Shell, one of the major oil & gas producing operators, he worked as an apprentice on drilling rigs in the Netherlands. After a year, he was sent for his first international assignment to the Sultanate of Oman where he climbed up the career ladder from Assistant Driller, to Driller, to wellsite Petroleum Engineer and eventually on-site Drilling Supervisor, actively engaged in the drilling of development and exploration wells in almost every corner of this vast desert area. At that time, drilling techniques were fairly basic and safety was just a buzz word, but such a situation propels learning and the fruits of 'doing-the-basics' are still reaped today when standing in front of a class. After some seven years in the Middle East, a series of other international assignments followed in places like the United Kingdom, Indonesia, Turkey, Denmark, China, Malaysia, and Russia. Apart from on-site drilling supervisory jobs on various types of drilling rigs (such as helicopter rigs) and working environments (such as jungle and artic), he was also assigned to research, to projects and to the company's learning centre. In research, he was responsible for promoting directional drilling and surveying and advised on the first horizontal wells being drilled, in projects, he was responsible for a high pressure drilling campaign in Nigeria while in the learning centre, he looked after the development of new engineers joining the company after graduating from university. He was also involved in international well control certification and served as chairman for a period of three years. In the last years of his active career, he worked again in China as a staff development manager, a position he nurtured because he was able to pass on his knowledge to a vast number of new employees once again. After retiring in 2015, he has delivered well engineering related courses in Australia, Indonesia, Brunei, Malaysia, China, South Korea, Thailand, India, Dubai, Qatar, Kuwait, The Netherlands, and the United States. The training he provides includes well control to obtain certification in drilling and well intervention, extended reach drilling, high pressure-high temperature drilling, stuck pipe prevention and a number of other ad-hoc courses. He thoroughly enjoys training and is keen to continue taking classes as an instructor for some time to come. 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
PYTHON BOOTCAMP: This 12-week Python Data Analytics Data Boot Camp is designed to give you a complete skill set required by data analysts . You will be fully fluent and confident as a Python data analyst, with full understanding of Python Programming. From Data, databases, datasets, importing, cleaning, transforming, analysing to visualisation and creating awesome dashboards The course is a practical, instructor-lead program.
IASSC lean six sigma black belt course. Online, 24/7 access to content and exam. Fee includes learning content, live webinars, tutor support, and official IASSC exam.