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
Explore practical neuroscience-backed tools to help you thrive in challenging circumstances.
EUSR SHEA Core Qualification – Safety, Health & Environmental Awareness The EUSR SHEA Core Qualification (Safety, Health and Environmental Awareness) is a foundational training programme that provides essential health, safety, and environmental understanding for individuals working across a wide range of industries, including utilities, construction, and engineering. Developed by Energy & Utility Skills, the SHEA Core qualification is recognised nationally and forms the basis of all SHEA schemes. It delivers a strong grounding in workplace safety principles and prepares learners for more specialised SHEA sector schemes such as SHEA Water, SHEA Gas, SHEA Power, and SHEA Waste & Resource Management.
Essential self-care for helping professionals New research gives us practical ways to prevent overwhelm or burnout in ourselves and others, manage workplace stress, avoid ‘compassion fatigue’ and much more… Accredited CPD Certificate: 6 hours Length: 1 day (9.15am - 4.00pm GMT) Really interesting and engaging online course with lots of tips to support ourselves and our clientsCOMPLEMENTARY THERAPIST Live Online Training – Join Emily Gajewski on Thursday 11th April 2024 to take some important time out for yourself, or to help those you support. Once you’ve booked your place we will email you confirmation and you will receive details of how to join the Zoom workshop the day before the event. Bonus Recording – the training is recorded, in case anyone experiences technical difficulties on the day, so you will also get a recording for a limited time afterwards to maximise your learning. Can’t make this date? Then please register your interest below – and we’ll email you when a new date is available. To help others effectively, we need to have enough ‘spare capacity’, which means looking after our own wellbeing too – new research shows us how… Why you should take this course When our day-to-day jobs involve continually listening to other people’s emotional difficulties, how do we avoid being overwhelmed by them ourselves or succumbing to compassion fatigue? We are the ‘tool’ of our trade. It could be argued that we have a duty to those we work with to prioritise our own mental health and wellbeing so that we can give them the best possible service. This live online training events shows you how. ‘Burnout’ is commonly defined as a physical and emotional state caused by excessive or overwhelming workplace stress. This is often specifically related to work but of course feelings of burnout can be impacted or compounded by other life events and caring roles too. Even if we know good stress management techniques, this often isn’t enough. Burnout is a very common phenomena in the ‘helping professions’, A 2018 research review paper published in the Journal of Clinical Psychology analysed 30 years of research on this topic, involving 9,000 psychotherapists. Over half of the therapists they sampled reported “moderate-high levels of stress and burnout”. The good news is that burnout, overwhelm and empathy fatigue are not a given of working in roles where we are consistently exposed to others’ emotional pain. New research and insights into ‘buffering’ the impact of this work mean that we can consciously choose to put in safeguards to our own mental wellbeing, whilst also remaining connected and present with our clients. Emily Gajewski’s online course draws on her extensive experience of working as a therapist and clinical supervisor, in the NHS and privately, for over 20 years. Throughout the day she examines the many ways working in the caring professions can impact us personally and gives you a wealth of practical steps you can take to mitigate them. She also covers the most up-to-date guidance on keeping ourselves well and thriving in caring roles and will help you develop a realistic plan for your own continuing wellbeing. Excellent online training…. very insightful and thought provokingHILARY KEARNS, ACUPUNCTURIST What you will learn The latest research on how to prevent burnout in your working life How to identify burnout in ourselves and others – the warning signs you need to look out for Easy, practical steps to protect yourself in stressful work situations How to avoid ‘compassion fatigue’ Evidence based ‘top tips’ for optimal working practices to maintain your own wellbeing The Cycle of Stress – how to ‘work with it’ for optimal health An understanding of vicarious trauma – and how to avoid it Techniques to calm yourself in client sessions when you are ‘triggered’ by something they bring up Understanding the difference between compassion fatigue and empathy fatigue Reducing your own risk of depression when you’re worried about your clients The joy of creating ‘flow’ in our working life Constructive ways to manage difficult feelings that arise as a result of your work Practical techniques for grounding and ‘letting go’ of clients How to safely explore our own areas of vulnerability Useful tips for ongoing stress management What you need to maintain your own mental health How to re-ground yourself if you’re feeling overwhelmed or derailed by a client An opportunity for you to reflect on your own practice and wellbeing, take some time to step back, learn what works for you and how you can create more spare capacity Time to relax, try out techniques and refresh your tools to support your wellbeing and build resilience How to utilise what you’ve learnt to create your own realistic wellbeing plan. Very useful and practical. The term ‘burnout’ is become as over-used as ‘wellbeing’ and ‘stress’. This online course provides clarity on what the term ‘burnout’ means in reality ... with strategies to counter the effectsHEADTEACHER SUPPORT SERVICE COUNSELLOR Course Programme The ‘How to avoid burnout’ live online course starts at 9.15am and runs until 4.00pm. (GMT). 9.15am Join the Zoom meeting 9.30am Understanding Burnout and how to halt the journey towards it 11.00am Comfort break and discussion 11.30am Exploring practical self-care steps that can work for YOU! 1.00pm Lunch break 1.45pm How to manage difficult feelings that arise as a result of our work 2.45pm Comfort break and discussion 3.00pm Creating a plan for your own wellbeing 4.00pm Day ends Who this workshop is suitable for Anyone who works within a role that involves caring for others – including: medical professionals – including GPs and nurses health and social care professionals therapists and mental health workers counsellors educators, teachers professional carers (foster carers and non-paid carers) social workers occupational therapists outreach workers volunteers holistic practitioners etc. This course has been independently accredited by the internationally recognised CPD Standards Office for 6 hours of CPD training. On completion of this training you’ll receive CPD certificates from the College and the CPD Standards Office.
The practice of Shamanic Healing invites us to reunite with our sacred path, and remember the journey of our Soul. Through the practice we have the chance to expand our connection with the Earth and the Cosmo, and experience oneness with all of life. The Level 1 is a nine months programme scheduled across one year. It is offered online via Zoom, over weekends, 10am - 4.30pm.
Ensuring learning and development contributes to improved performance in the workplace at an individual, team and organisation level.
Identifying learning and training needs, designing and sourcing training and learning solutions, delivering and evaluating training.
Develop the commercial awareness, financial knowledge and strategic thinking capabilities, to influence the direction of the business Course overview Duration: 2 days (13 hours) This course is aimed at managers who want to develop their commercial awareness, financial knowledge and strategic thinking capabilities, so that they can influence the direction of their business and deliver to their full potential. Day one of the course provides the skills and insights to make sense of your company’s financial position and performance. Day two helps delegates to consider the strategic thinking tools required to plot the forward course needed to maximise the potential of the business. As well as looking at how to make effective business decisions, this course gives a good grounding in finance and profitability. As a two day programme, day one provides the skills and insights to make sense of the company’s financial position and performance. Day two then considers the strategic thinking tools needed to plot the forward course needed to maximise the potential of the business. Objectives By the end of the course you will be able to: An understanding of the balance sheet, profit and loss account, cash flow and statutory and management accounts Learnt to correctly employment key financial ratios to analyse your business A practical definition of strategy analysis tools to examine the current environment and capabilities Steps to devise a mission and vision statement Recognition of the skills and resources needed to achieve the vision Generation of appropriate strategic and tactical commercial objectives Content What is Strategy Defining Strategy Strategic thinking Strategic models Commercial thinking – what is money? Where are we now STEEPLE analysis SWOT Analysis P&E forces at work Political distortions in capitalist markets Where are we trying to get to Setting the mission and vision Creating a BHAG Strategies for deflation and inflation The role of banks Commercial and investment banking Fractional reserving Securitisation How to get there Skill gap analysis Business Process Re engineering The role of creativity How to get there Getting the team on board Individual and team motivation The power of the brand Overcoming challenges Debt and deleveraging Change management Creating value Discounted Cash Flows Building the business case Asset Valuation techniques Making it happen Turning Strategic Thinking into Strategic Plans Scenario planning for an uncertain future Creating commitments and lock in Discussion and review Time will be set aside during the course for review sessions with time for questions, answers and action learning.