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
Clinical skills, HCAs, Nurses, Chronic disease
The “ISO 14298:2021 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of a Security Printing Management System based on ISO 14298:2021. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective security printing management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 14298 standard.
Writing and Managing Requirements Documents This course is part of IIL's Business Analysis Certificate Program (BACP), a program designed to help prepare individuals pass the IIBA™ Certification exam to become a Certified Business Analysis Professional (CBAP™). Learn more at www.iil.com/bacp. Once a business analyst has completed the information gathering and analysis to produce the solution to a business problem, the results must be documented for all stakeholders to see and understand. This course will enhance the skill set needed for writing and managing the complex readership that business analysts interact with on a day-to-day basis. What you will Learn Upon completion, participants will be able to: Write an understood requirements document that is approvable and acceptable Validate a requirements document Manage the changes to requirements documents through the SDLC Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide The business analyst and the product/project life cycle The requirements documentation process Planning for Effective Requirements Documentation Overview of requirements planning Planning for validation Planning for verification: well-formed criteria Planning for verification: understood and usable criteria Writing Effective Requirements Documents Overview of writing requirements documents Using a standard structure / template Applying formatting techniques Meeting the challenge of writing non-functional requirements Baselining Requirements Documents Overview of the requirements baseline process Validation Verification Approval Managing Requirements Change through the Product Life Cycle Overview of requirements change management Establishing a formal change management process Tracing requirements through design and development (build, test, and implementation) Following through to post-implementation (transition and early production)
The “ISO 42001:2023 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of an Artificial Intelligence Management System based on ISO 42001:2023. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective Artificial Intelligence management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 42001 standard.
Writing and Managing Requirements Documents: In-House Training This course is part of IIL's Business Analysis Certificate Program (BACP), a program designed to help prepare individuals pass the IIBA™ Certification exam to become a Certified Business Analysis Professional (CBAP™). Learn more at www.iil.com/bacp. Once a business analyst has completed the information gathering and analysis to produce the solution to a business problem, the results must be documented for all stakeholders to see and understand. This course will enhance the skill set needed for writing and managing the complex readership that business analysts interact with on a day-to-day basis. What you will Learn Upon completion, participants will be able to: Write an understood requirements document that is approvable and acceptable Validate a requirements document Manage the changes to requirements documents through the SDLC Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide The business analyst and the product/project life cycle The requirements documentation process Planning for Effective Requirements Documentation Overview of requirements planning Planning for validation Planning for verification: well-formed criteria Planning for verification: understood and usable criteria Writing Effective Requirements Documents Overview of writing requirements documents Using a standard structure / template Applying formatting techniques Meeting the challenge of writing non-functional requirements Baselining Requirements Documents Overview of the requirements baseline process Validation Verification Approval Managing Requirements Change through the Product Life Cycle Overview of requirements change management Establishing a formal change management process Tracing requirements through design and development (build, test, and implementation) Following through to post-implementation (transition and early production)
This verification of expected death training is suitable for nurses who are interested in taking on the extended role of verification of expected death within various healthcare settings.
Why Choose Revit Basic to Advanced Training Course? Course info. Revit Basic to Advanced Master complex 3D modeling, BIM workflows, and project phasing. In-person or live online options available. Enroll now to elevate your architectural, engineering, and construction projects with advanced Revit techniques. Duration: 16 hours Methof: Personalized 1-on-1. Customized Schedule: Choose a convenient hour from Mon to Sat between 9 am and 7 pm to create your own schedule. Revit Basic to Advanced Training Course: Learn the fundamentals of Revit for architecture and structural design, supporting BIM workflows for efficient building construction. Delivery Options: In-class at our center Live online sessions Who Should Attend? Ideal for architects, building designers, structural engineers, and general users. Course Outline: I. Introduction to Revit Explore Revit's purpose and applications Familiarize yourself with the user-friendly interface and essential tools Navigate efficiently and control viewports Initiate and save projects for future reference II. Setting up a Project Create new projects and use templates for efficiency Establish project levels, grids, and crucial building information Configure project units for precision and consistency III. Basic Modeling Master the creation and customization of walls, doors, and windows Develop floors, ceilings, and roofs for complete building structures Craft functional and aesthetically pleasing stairs and railings IV. Advanced Modeling Learn to design custom parametric families to enhance productivity Explore conceptual modeling tools for creative freedom Integrate lighting and materials for realistic 3D rendering V. Views and Sheets Efficiently manage views and organize them effectively Generate informative and well-structured sheets for documentation Integrate schedules and tags to enhance information clarity VI. Annotation and Detailing Add clear and concise text and dimensions to your designs Customize detail components for precise annotations Employ symbols and keynote legends for standardized documentation VII. Phasing and Worksharing Grasp the concepts of phasing and design options Manage and modify phases effectively Collaborate seamlessly with worksharing features VIII. Project Collaboration and Management Establish a productive worksharing environment Monitor and track worksets and user activities Synchronize worksets for a coordinated team effort IX. Advanced Documentation Create specialized and advanced schedules for comprehensive project insights Develop legends and keynotes to enhance documentation clarity Finalize construction documents with professional-looking sheets and title blocks X. Conclusion and Next Steps Recapitulate the course content and achievements Receive valuable tips for continuous learning and further resources Engage in a Q&A session to address any remaining queries or concerns For more information and to start your learning journey, visit our website or download the free trial of Autodesk Revit from the provided link: https://www.autodesk.co.uk/autodesk/revit