Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. 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 and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 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
This course is for anyone working with adults with learning disabilities. Aim The aim of this course is to develop the knowledge, confidence and practical skills of participants to support people with learning disabilities through the menopause Learning outcomes By the end of the training participants will have: • Learnt about the main symptoms of the menopause • Considered how people with learning disabilities might experience the menopause • Thought about their proactive role in terms of supporting people with learning disabilities with the menopause • Practiced the skills of communicating with people with learning disabilities about the menopause • Explored relevant accessible resources and organisations to support this work Course Outline • Welcome and introductions • Working Agreement • Symptoms of the menopause • The menopause and people with learning disabilities • Roles and responsibilities • Case studies • Communication • Resources • Close This is a virtual training course, you will be sent a pack of information to a postal address of your choice around a week before the course. The course will be run on Zoom, it is your responsibility to ensure you can access Zoom on the day.
Closed groups of 6 to 18 learners per session. Learn how to engage in meaningful conversations about workplace wellbeing with the supports designed to enhance your skills as an effective leader. Empowering leaders and managers to support mental wellbeing in the workplace. This comprehensive course is designed to equip learners with the necessary knowledge and skills to support themselves and their team’s wellbeing.
Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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 14 Points Development Level Develop
Cloud deployment training course description This course covers the important topics every cloud professional needs, including, configuration and deployment, security, maintenance, management, and troubleshooting. It covers all aspects of cloud computing infrastructure and administration, with a practical focus on real-world skills. It will help you to master the fundamental concepts, terminology, and characteristics of cloud computing. Deploy and implement cloud solutions, manage the infrastructure, and monitor performance. You will also be able to install, configure, and manage virtual machines. What will you learn Cloud services, models, and characteristics. Virtualization components, installation, and configuration. Infrastructure configurations and optimization. Resource management and specific allocations. IT security concepts, tools, and best practices. Recovery, availability and continuity in the cloud. Cloud deployment training course details Who will benefit: IT professionals looking to deploy and implement cloud solutions, manage the infrastructure, and monitor performance, Install, configure, and manage virtual machines. Prerequisites: Introduction to virtualization. Duration 5 days Cloud deployment training course contents Preparing to Deploy Cloud Solutions Deploying a Pilot Project Testing Pilot Project Deployments Designing a Secure and Compliant Cloud Infrastructure Designing and Implementing a Secure Cloud Environment Planning Identity and Access Management for Cloud Deployments Determining CPU and Memory Sizing for Cloud Deployments Determining Storage Requirements for Cloud Deployments Analysing Workload Characteristics to Ensure Successful Migration Maintaining Cloud Systems Implementing Backup, Restore, Disaster Recovery, and Business Continuity Measures Analysing Cloud Systems for Performance Analysing Cloud Systems for Anomalies and Growth Forecasting Troubleshooting Deployment, Capacity, Automation, and Orchestration Issues Troubleshooting Connectivity Issues Troubleshooting Security Issues
Manifest Good Fortune and Happiness Through focused intention, emotion, and visualization, and with the aid of ceremonial cacao, we will connect more deeply to the energy of the heart with a gentle and immersive meditation to manifest and bring your goals, dreams, and desires into physical form. #manifestation #newmoonceremony #ceremonycacao #sacredcacao #surbitonmums #surbiton #surreylife #surbiton #kingstonuponthames #manifesting #newlife #fullmoonmanifestation #crystalgrid
Gain expertise in process safety management engineering through EnergyEdge's course. Participate in our classroom training to enhance your skills and knowledge.
LOOKING FOR: MG, ADULT FICTION Jo Williamson has been in publishing for over 25 years. Having worked in Children’s books PR for Dorling Kindersley, HarperCollins and Orion, she started as an agent with Antony Harwood in 2008. She feels very privileged being with authors at the very start of their publishing journey and enjoys close working relationships with all her clients. From editorial help, general advice on the publishing world, guiding careers long-term and general cheerleading, she feels she has the perfect job. Although nothing is off limits and she loves being surprised by submissions, In middle grade children's fiction, Jo is particularly looking for books with heart, epic adventures with voice-led characters, and younger funny fiction with series potential. In adult fiction, page-turning Commercial Women’s and Book Club fiction are right up Jo's street, including psychological suspense, thriller, cosy crime and books that don’t quite fit the mould. Above all, she wants stories that linger long after the final page has been read. Jo is not the right fit for police procedurals. Jo would like you to submit a covering letter, 1 page synopsis and the first 5,000 words of your manuscript in a single word document. (In addition to the paid sessions, Jo is kindly offering one free session for low income/underrepresented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print). By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Monday 6 January 2025
All occupational health and safety practitioners (OHASPs) need to have a common core of knowledge in order to practise effectively. The NEBOSH National Diploma aims to provide the knowledge and understanding that underpins competent performance as an OHASP.