27468 PLA courses delivered Online

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

Official BRCGS Food Safety Issue 9 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Whetstone Communications and comms2point0 are pleased to bring you the Data Bites series of free webinars. Our aim is to boost interest and levels of data literacy among not-for-profit communicators.

Brightcore Consultancy delivers Senior Mental Health Lead training in schools and colleges which meets the Department for Education’s quality criteria, and our course is in fact the highest rated of all the nationally DfE approved Senior Mental Health Lead training courses, scoring a perfect 5/5 in each of the 9 DfE quality assurance standards during the quality assurance process.

Official BRCGS Packaging Auditor Issue 6 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

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.

Welcome to the Women's Voice Medicine Journey. This is a female-designed, step-by-step programe, to teach you how you can truly activate and integrate some of the most essential Embodied Voicework tools to Free Your Voice and unleash your Creative Feminine Power.

Official BRCGS Packaging Auditor Conversion to Issue 7 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Official BRCGS Packaging Sites Conversion Issue 7 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

What important conversations are your team members avoiding? Side-stepping difficult conversations can trap a team in unresolved problems, strained relationships, and missed chances for growth, which blocks progress and cultivates a lack of trust. But many people avoid difficult conversations or handle them poorly because they’re afraid to address uncomfortable issues and feel unprepared to respond to the emotional reactions that inevitably arise. Navigating Difficult Conversations: Turn Tension Into Progress takes a targeted approach to helping people to manage emotional tension and conduct conversations in a way that enables all parties to stay engaged in collaborative dialogue. Participants will shift their mindset from fearing and avoiding difficult conversations to seeing them as the way to make progress on important issues. And they’ll develop the skills to build trust and respect in every relationship as they navigate sensitive topics. Who Should Attend? This programme is for anyone who finds the thought if having a challenging or difficult conversation, something to be very nervous of, even to the point of avoiding the issue. We recommend that participants have first attended our Aspire programmes, Management Essentials and Performance Coaching, as they provide a strong foundation to the topic, which this session then builds upon. In Navigating Difficult Conversations participants will discover how to balance Courage and Consideration throughout the conversation by: Sharing their Purpose—the issue they need to make progress on—and Positive Intent—how they want the other person to benefit from the conversation Responding to emotional reactions using the skills: Pause, Don’t Panic Observe, Don’t Judge Ask, Don’t Assume Outcomes This module will help participants: Create a strong foundation for difficult conversations by setting a clear and collaborative tone that balances their own and others’ needs. Understand that emotional reactions are a natural, human response—and notice them as a signal that the conversation needs an adjustment to stay on track. Practice a range of tactics to respond in the moment to help everyone stay engaged and make progress.