213 Mapping courses

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

Face to face training customised and bespoke. Online or Face to Face

Inclusion Facilitation (IF) is an approach to enhancing the inclusion, in a mainstream community of any child or young person who is experiencing difficulties in the world because of disability, personal crisis or because of their challenging behaviour towards others. The IF approach works by mobilising the young person’s natural supports to provide support and engage with the person in difficulty. Inclusion Facilitation is designed to create a better life for an individual by the provision of an intense input designed to being about social change. This usually entails a series of visits focused on getting the person out and about to increase confidence, social skills and presence in their local community and to pursue goals and dreams. Uniquely, the work is carried out under the close clinical supervision of a practicing psychologist. What is Inclusion Facilitation Work? ‘We do whatever it takes!’ Usually a Person Centred Planning event would be carried out using the PATHor MAP process – majoring on dreams and goal setting leading to precise action planning.  An experienced psychologist alongside the inclusion facilitator would carry out a PATH. A large graphic will be one of the outcomes of the meetings this is a great visual record and a shared memory of the event. This will also inform the priorities for the inclusion facilitation work Optionally following the PATH event a ‘scoping report’ is created outlining what Inclusion Facilitation could offer and highlighting what dreams and goals the individual has. The PATH is also provides a good opportunity for the Facilitator to meet the focus person in a comfortable positive environment. 12 weekly visits from the Inclusion Facilitator followed by 5 monthly visits is our preferred model but we can be flexible with the delivery of this input. This is just a guideline, however we have received good results using this time frame. After this intensive input the Inclusion Facilitator will hand over to the existing family, carers and PA team to carry on where he or she has left off. This transition time is planned from the outset. An experienced psychologist is there to support the facilitator at all times and will guide all work done by the inclusion facilitator.  Is this just Support work? No! This is proactive engagement – doing whatever is required. We are not just passively or reactively providing what is asked for – we are actively pursuing a good life for the individual. Our work is built on careful research around a person’s interests and what opportunities exist locally. We carry out community mapping.  We actively work to tackle an individual’s own resistance and reluctance to engage more socially. We actively engage with people in social settings that the individual attends to build bridges and connections – we are bridge builders. We build circles around a person. We create the conditions in which friendships can flourish. We have direct psychological supervision and support throughout. This work is short term and intense. Enjoy participating in a multimedia workshop that will challenge, entertain and reach for your emotions. Learning Objectives 1.To be able to understand the values and wider context of inclusion. 2.To be able to set up and run an ‘Inclusion Facilitation project to improve the life chances and connections of a child or young person. 3.To understand and be able to maximise the power of the peer group in supporting relationships, achievement and behaviour. Course Content The course answers the questions: What do you do with the child who is isolated by their aggression and anger, through being different, disabled or new to the school or community? Practically how do we go about including high profile children or young people? How can we help some children be friends? We will cover:  Inclusion values underpinning this work The Intentional Building of Relationships –‘Inclusion Facilitation’ work as an example Not doing it alone – The Importance of Teams in developing inclusive practice Practical setting up and running of IF work Lessons learned Stories of IF work

Python Data Analytics boot camp. 12 1 day lessons, learn Python Basics through to machine learning and front-ends. With practical project to give you full confidence and credibility.

The “ISO 27001: 2013 Lead Auditor” course provides comprehensive training in the ISO 27001: 2013 standard and all its requirements from the Lead auditor’s point of view, as well as basic skills necessary to Lead audit activities. It’s a practical-oriented training that should be considered “a must” for every ISO 27001: 2013 Lead auditor.

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

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

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

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

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