310 Medicine & Nursing courses in Cambridge

Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information 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. CPD Points 14 Points   Development Level Develop

Gain advanced knowledge and practical skills in instructing buccal midazolam administration for epilepsy with our Level 4 Award course.

Enhance your clinical expertise with our "Extended Clinical Skills Training" course. Designed for healthcare professionals, this course provides practical skills and knowledge for extended clinical procedures and interventions.

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face 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 23 Points   Development Level Develop

Gain a comprehensive understanding of immunisation and vaccines with our "Foundations of Immunisation and Vaccines" course. Designed for healthcare professionals, public health workers, and individuals interested in immunisation, this course covers vaccine development, administration, safety, and the role of vaccines in preventing infectious diseases.

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Gain certification as a safe people handling instructor and assessor with our comprehensive course. Equip yourself with the necessary skills and knowledge to effectively train and assess others in safe manual handling techniques.

Gain comprehensive knowledge and practical skills in asthma and anaphylaxis management with our evidence-based training course. Ideal for healthcare professionals, educators, and patient care providers. Optimise patient outcomes with effective emergency response protocols, prevention strategies, and patient education.

Enhance your venepuncture skills with our comprehensive course. Learn evidence-based techniques, infection prevention measures, patient-centered communication, and ethical considerations to ensure safe and effective practices.

Learn to teach basic life support effectively with our "Promoting Best Practice in Basic Life Support Instruction" course. Ideal for healthcare professionals, educators, and individuals interested in life-saving interventions.