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
Hypnotherapy Training Course
Course Introduction Our Venepuncture and Phlebotomy training equips delegates with the skills and knowledge needed to take blood safely. Please note: this course is for health care professionals and nurses only. About this event Applicable to Nurses, Health Care Assistants and Phlebotomists in primary care, the community, hospitals or nursing homes, this course is interactive and involves a demonstration session on performing blood tests. Our venepuncture training will give delegates the theoretical and practical awareness to undertake a competence assessment framework in the workplace that will deem them competent to take blood safely and appropriately. Each delegate will receive a competence-based framework to allow them to do this. Course Aims Identify and describe equipment used for routine venepuncture Be able to assess and select suitable sites used for venepuncture as well as locations to avoid Describe and utilize the required steps to perform routine venepuncture Describe actions that ensure safety during performance of a venepuncture Identify suitable vein selection and identify factors influencing this Understand relevant professional and legal issues Be able to identify potential complications Understand anatomy and physiology and correct vein selection Be familiar with equipment and exercise choice in using most appropriate equipment Practice safely in terms of infection control and waste management Become skilled and competent at phlebotomy To recognise any complications arising and be able to take the appropriate action Course Content Background and importance of training and competence Supervision and practice Scope and responsibilities Accountability Professional and legal issues Consent and capacity What is phlebotomy? Tools of the trade-equipment Needles and patient safety Blood collection systems and devices Syringes and when to use them Blood collection tubes Labelling Anatomy and physiology Vein Selection: - Identification of Veins - Arm Veins - Hand Veins Vein assessment Unacceptable sites for venous collection Venepuncture procedure Attempts Order of Fill Specimen collection procedures Specimen handling post-phlebotomy Personal protective equipment Needle stick injuries Legislation-EU Directives Disposal Needle phobias Dealing with anxiety/fainting etc. Practical session Potential Complications (including infection control) Practical Application - techniques and troubleshooting Case scenarios Troubleshooting Audit Who should attend / would be applicable? Nurses HCAs Those interested in careers as Phlebotomists AB Health Group awards CPD points / certificate of attendance for each course. If you would prefer an accredited certificate by our accrediting body Aim Qualifications we can organise this. The charge for the certificate including postage is £30.00. Annie Barr AB Health Group Organiser Description Annie Barr is a leading provider of high quality, accredited healthcare training. With a selection of engaging healthcare training that has been developed by experts to equip you and your workforce with the skills, knowledge and competence needed to provide compassionate and high quality care.
Non-Invasive Ventilation Course CPAP and BiPAP Training Respiratory Support Course NIV Techniques for Nurses Cough Assist and High Flow Training CPAP and BiPAP Certification Non-Invasive Ventilation for HCAs/Carers Home and Hospital NIV Training CPAP and BiPAP Online Course The CPD Standard Office Accredited NIV Course Revalidation
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