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
Peer mediation is an approach to impacting on conflict resolution and bullying in primary and secondary schools by training pupils to be mediators or ‘counsellors’. This well proven, highly effective method of impacting on school based bullying is still viewed by some as radical. In this workshop participants are introduced to the key components of successful schemes. Our trainers have first hand experience of setting up school based schemes and sustaining these over time. Peer Mediation Training Guide Online Course now available via Teachable Platform – Peer Mediation Learn at your own pace… lots of text and video support Course Category Peer Support Description Peer mediation or peer counselling is an approach to impacting on bullying in primary and secondary schools by training pupils to be ‘Peer Mediators’ or ‘counsellors’. This well proven, highly effective method of impacting on school based bullying is still viewed by some as radical. We can provide training for staff or direct training with students across the age range – typically delivered over 6 short high impact, interactive learning workshops. For staff training, participants are introduced to the key components of successful schemes. Our trainers have first hand experience of setting up school based schemes and sustaining these over time. Enjoy participating in a multi media workshop that will challenge, entertain and reach for your emotions. Watch young people doing their stuff! Testimonials Thank you for the course – I really enjoyed it Learning Objectives To be able to understand the values and wider context of peer support To be able to set up and run a peer counselling scheme to reduce bullying To understand and be able to maximise the power of the peer group in supporting relationships, achievement and behaviour change Who Is It For ? Year 5 or Year 10 pupils Primary and secondary teachers Heads and Deputies SENCOs Learning Support and Guidance staff Advanced Skills Teachers Parents Local Authority Support Services Community Development workers Early Years and School based Practitioners Course Content The course answers the questions : What do you do with major bullying problems in school? Practically how do we go about recruiting and training pupils as counsellors? Will pupils be hurt if we involve them with bullies? Key Themes covered within the direct student training as well as in the staff development sessions- include: Issues of Confidentiality Welcoming your ‘client’ Using active listening skills Using Open and Closed Questions to enable your client to tell you his or her story How to reflect back feelings and how to check you have understood what the client has told you Exploring options for resolving the bullying issue with your client This video gives a brief taster of the work in a Nottingham Primary school. If you liked this course you may well like: PEER SUPPORT AS AN ANTI-BULLYING STRATEGY AT LOCAL AUTHORITY LEVEL
Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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 19 Points Development Level Develop
Online Asset Management course. This IAM Certificate course will be hosted online, December 2023.
Hire us for the first dance at your wedding, any Salsa or Latin Dance rhythm private class at your venue or at our premises in Hammersmith. We have a vast experience on building up confidence in couples who want to make even more glamorous their wedding day. You can have this lesson at our premises, on Zoom, Pre-recorded or home visit, the choice is yours!!! The Program includes: 5 or 10 Lesson 1on1 lesson Walking & Leading techniques Female & Male Teachers Footwork & Upper body techniques Steps & routines names (brain method) Body posture and language Tempo & beat music technique Fully equipped dance studio Ownership of your footage work progress & Docs Music library via dropbox or Spotify Salsa or any Latin Dance (Tango, Bachata, Merengue, etc) wedding class in London for couples who want to make the wedding day even more glamorous and stand out forever, 5 minimum pack lesson book, Taught by the native instructor We have been training couples for almost 12 years in salsa, Tango, Samba, and many other Latin rhythms in London
FAA Level 1 Award In Awareness Of First Aid For Mental Health (RQF) Classroom (4.5 hour course), Virtual (2 x 2 ½ hour sessions) Gives learners a good awareness of Mental Health First Aid Gives learners the skills to start that difficult conversation Course Contents: What is Mental Health? Why people develop mental health conditions What the role of a mental health first aider is Knowing how to provide advice and practical support Knowing how to recognise and manage stress Recognising a range of mental health conditions: Depression Anxiety Psychosis Eating disorders Suicide Self-harm Benefits of this course: 37% of all work-related ill-health is due to mental health problems Problems with mental health cover 45% of all working days lost A whopping 12.8 million working days, or 49, 042 years, were lost due to mental health problems in 2018/19 602,000 workers suffered from work-related stress, depression or anxiety in 2018/19 One in four people will have a mental health problem at some point during their lives Whether work is causing or aggravating mental health problems, employers have a legal responsibility towards their employees Work-related mental health issues must to be assessed to measure the levels of risk to staff Where a risk is identified, steps must be taken to remove it or reduce it as far as reasonably practicable This half day course gives people a good awareness of mental health in the workplace For a more complete introduction, see our full day First Aid for Mental Health or two day Supervising First Aid for Mental Health courses Accredited, Ofqual regulated qualification This Awareness of Mental Health First Aid Course is a nationally recognised, Ofqual regulated qualification accredited by First Aid Awards. This means that you can be rest assured that your Mental Health First Aid Certificates fulfil the upcoming legal requirements and are a very good way to make sure you and your employees have a supporting workplace to deal with staff's mental health conditions. The Ofqual Register number for this course is 603/3768/0
Highfield Level 1 Award In Food Safety In Retail (RQF) Half day course Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely This Level 1 Award in Food Safety for Retail helps to prepare people for working in a low-risk role, where some food handling takes place. Course Contents: The Importance of Food Safety Legal responsibilities of food handlers Personal hygiene Contamination and cross contamination The importance of keeping one's work areas clean Pest control Basic bacteriology Benefits of this course: Businesses have a duty to their customers to produce food that is safe for consumption. There are one million cases of food poisoning in the UK each year. More than 6,000 are admitted to hospital. In 2014/2015, businesses in Chesterfield were issued 344 written enforcement notices. Derby received 1,116. Doing our Ofqual regulated, nationally accredited course ensures that nothing of importance is left out. EU and UK regulations state that all food handlers must receive appropriate training in food safety practices relevant to their duties. The Food Standards Agency says that 'Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely’. This Highfield Level 1 Award in Food Safety in Retail (RQF) is a nationally accredited qualification especially suitable for people working in, or planning to work in, the food retail industry where some food handling takes place Accredited, Ofqual regulated qualification: This Level 1 Food Safety in Retail training course is a nationally recognised, Ofqual regulated qualification accredited by Highfield Qualifications. This means that you can be rest assured that your level 1 Food safety in Retail certificate fulfils the legal requirements and is a very good way to make sure your low-risk employees are appropriately trained in Food Safety. The Ofqual Register number for this course is 603/2617/7
Highfield Level 1 Award In Food Safety In Catering (RQF) Half day course Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely This Level 1 Award in Food Safety in Catering helps to prepare people for working in a low-risk role, where some food handling takes place. Course Contents: The Importance of Food Safety Legal responsibilities of food handlers Personal hygiene Contamination and cross contamination The importance of keeping one's work areas clean Pest control Basic bacteriology Benefits of this course: Businesses have a duty to their customers to produce food that is safe for consumption. There are one million cases of food poisoning in the UK each year. More than 6,000 are admitted to hospital. In 2014/2015, businesses in Chesterfield were issued 344 written enforcement notices. Derby received 1,116. Doing our Ofqual regulated, nationally accredited course ensures that nothing of importance is left out. EU and UK regulations state that all food handlers must receive appropriate training in food safety practices relevant to their duties. The Food Standards Agency says that 'Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely’. This Highfield Level 1 Award in Food Safety in Catering (RQF) is a nationally accredited qualification especially suitable for people working in, or planning to work in, the food retail industry where some food handling takes place Accredited, Ofqual regulated qualification: This Level 1 Food Safety in Catering training course is a nationally recognised, Ofqual regulated qualification accredited by Highfield Qualifications. This means that you can be rest assured that your level 1 Food safety in Catering certificate fulfils the legal requirements and is a very good way to make sure your low-risk employees are trained appropriately in Food Safety. The Ofqual Register number for this course is 603/2615/3
QA Level 2 Award In Safe Moving And Handling (RQF) Full day course (classroom) Provides a good understanding of the principles of safe manual handling Gives learners the ability to apply the principles of safe manual handling Benefits of this course: 470,000 people people suffered from musculoskeletal disorders due to work related activities in 2020/2021 Of those, 162,000 were from people who had not suffered this before 8.9 million working days, or 37,083 working years, were lost due to work-related musculoskeletal disorders in 2019/2020 This course is here to help people avoid getting injured in the first place, saving both human suffering and cost to the employer and employee both Course Contents: Common manual handling injuries Manual handling laws Responsibilities of employers and employees Manual handling risk assessments Safe movement principles associated with manual handling, including the body’s:Musculoskeletal systemCentre of gravityLever system Manual handling equipment:Types of manual handling aids and equipmentMaintenance and requirements for testing Manual handling practical sessions: Preparing for a lift Solo lifting, carrying and lowering an object Team manual handling Accredited, Ofqual regulated qualification: Our Safe Moving and Handling Course is a nationally recognised, Ofqual regulated qualification accredited by Qualsafe Awards. This means that you can be rest assured that your Manual Handling Certificate fulfills the legal requirements and is a very good way to make sure you and your employees are trained appropriately in Manual Handling. The Ofqual Register number for this course is 603/2744/3
This one-day course introduces the field of user experience and provides an excellent entry point to our other specialised training courses. UX processes and practices have become a central component of product design, service design and web design.