Courses

This course will develop knowledge from the FD&FA foundation BS 5839-1 module and/or industry experience and apply this to the design of FD&FA systems.

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

An exciting 10-week course to build your Spanish skills from scratch. Practical applications for travel & conversation. Enlarge your vocabulary, improve your grammar in a pain-free, step-by-step way, working with a tutor with 10+ years' experience & a small group of learners.

Become a META-Health professional with our 6 months intensive training! Do you want to learn the scientific background of body-mind-interactions and how to integrate this knowledge in your practical work with your clients? This course contains both self-study and live training in online classes and covers the META-Health Level 1 and 2 material. It will take 6 months including 24 live sessions, 2 hours each, mainly in a weekly rhythm. You will get preparatory videos, reading material and tasks that help to understand and integrate the content, while the group sessions focus on demonstrations, discusion of the material, and practical exercises for you. All the time, our trainers and tutors will support you and we’ll be a learning family with an active chatgroup. Altogether you should reckon approximately 5 hours per week.

Monthly free to attend support group for people with hoarding behaviour. Facilitated by Founder/Chair Megan Karnes. Provides both psychological and practical support.

The Mechanics of Mediumship. A beginners guide to everything you need to know. How to become a professional psychic medium. Able to give short, accurate, evidential messages. This course runs over 5 weeks and during our time together we will explore five easy to follow parts. 1: What mediumship is and the different types, including your role as a professional medium and the differences between working in the psychic modality and when you are connected to spirit. 2: Activating and building your power within, and the difference between meditation, and attunement both to the spirit world and using your psychic modality. 3: The six different senses available to you, which are your strongest and whether you are perceiving them objectively or subjectively. 4: What is and what is not evidence in mediumship, understanding the different types of evidence available and defining practical and emotional evidence. 5: Surrendering to spirit, building confidence to receive specific unique information, and understanding the reasons why you receive a no response. Guidance on making positive, strong, statements filling your sitter with confidence, building a truly extraordinary professional reading.

Historical Association webinar series: History and literacy: better together Presenter: Andrew Wrenn This practical webinar will look at the vital role speaking and listening plays in helping pupils to think, read and write in historical ways as well as developing general oracy skills. It will explore a range of strategies and tasking that can help pupils deepen their historical understanding, gain a better grasp of complex ideas, and learn how to articulate these so that they can reach (and justify) independent conclusions of their own. To use your corporate recording offer for this webinar please complete this form: https://forms.office.com/e/HYhgpvBBuG

GDPR Practitioner

THIS COURSE PACKAGE INCLUDES: 1: INTRODUCTION TO PHLEBOTOMY COURSE (GPT003) - Level 3 (Ireland Level 5) 2: ADVANCED PHLEBOTOMY COURSE (GPT005) - Level 4 (Ireland Level 6) 3: GEOPACE COMPETENCY CERTIFICATE - CPD Certified (optional with Virtual Classroom) Learn how to take blood ... train as a Phlebotomist FAST-TRACK YOUR PHLEBOTOMY TRAINING WITH OUR COMPLETE TRAINING PACKAGE 20% off - Multi-Course Discount Cover all stages from beginner through to Level 4 Available as Classroom or Virtual Classroom Complete your beginner to advanced training in 2 days Awards 2 accredited qualifications - Introduction to Phlebotomy and Advanced Phlebotomy qualifications Both courses are dually accredited (OCN & CPD) Geopace Certificate of Competency included with classroom attendance or available as an option when booking virtual classroom Covers all steps up to live blood draw Learn advanced skills and techniques Virtual Classroom options include comprehensive Practise@Home Training Kits (yours to keep) Basic understanding of English language required OPEN TO ALL APPLICANTS

This training is designed for lawyers and covers key topics to ensure compliance with the Specialist Quality Mark (SQM) and other regulations.