509 Opera courses in St Neots

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

Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 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 14 Points Development Level Develop

About this VILT Tripod can be used in any area of business where the organisation has a management system in place to prevent unwanted events e.g., health, safety, environment, quality, security, productivity, project management, and many more Tripod Beta is one of several tools based on Tripod's fundamental principles. Tripod Beta is based on proven theories, man years of academic research, and testing in the workplace. The Swiss Cheese Model originated from this work. Features of the methodology are: 1) the Tripod Beta diagram; it provides an easy-to-read summary of the entire investigation on a single page, 2) it accommodates deficiencies in leadership and worker participation, 3) it accommodates deficiencies in human behaviour, and 4) it highlights missing controls (not just controls that failed). Quality throughout all aspects of Tripod is assured by the Stichting Tripod Foundation (STF) and the Energy Institute. The participants will gain a theoretical understanding of the Tripod Beta methodology and terminology. They will be able to read Tripod diagrams and reports, and be able to assist incident investigation/analysis as a team member. This is the first step to becoming an accredited silver or gold practitioner. Tripod Beta Practitioner Accreditation is meant to build these skills, through a blend of support, coaching and assessments. Feedback is provided on Tripod incident investigation reports, giving the Practitioner the opportunity to hone their skills and become confident in their ability to use Tripod effectively. Training Objectives Upon completion of this course, participants will be able to: Pass the Tripod Beta Practitioner (Bronze Level) exam Act as a team member or Tripod facilitator on an incident investigation Plan and schedule activities for an incident investigation Focus line of enquiry during an investigation Engage with the most relevant people at each stage of the investigation Describe the incident causation paths in terms that align with their management system Consider issues relating to leadership, worker participation and human behaviour Assess the quality of an incident report Apply the process to any type of unwanted event that should have been prevented by a management system e.g., health, safety, environment, financial, security, productivity, quality, project management etc. Combine the findings from many incidents with data from other initiatives e.g., audits and inspections, to spot trends to prioritise actions and product a single improvement plan Target Audience The course is recommended for anyone who is expected to play a role in designing, reviewing, auditing, and following your organizations OH&S management system. Successful participants will be awarded the Stitching Tripod Foundation Tripod Beta Bronze certificate. The following oil & gas company personnel will benefit from the knowledge shared in this course: CEO Team Leaders Legal, insurance and finance departments Managers (Line and Function) Maintenance Engineers Quality Assurance Engineers Process Engineers Incident Investigators (Team member & Tripod facilitator) Project Managers System Custodians Technical Authorities Key Contractor's Management Contract Managers/Holders Safety Representatives Risk Management Engineers HSE Advisors Supervisors Auditors Regulators Course Level Basic or Foundation Trainer Your expert course leader has over 30 years of experience in construction, operations and maintenance with the upstream exploration and production sector. He joined Shell International E&P in 1971 and for 28 years worked in several locations around the world. Following the Piper Alpha incident he led Shell's two year, £10M major overhaul of their permit to work system. He first made use of the Tripod Beta principles during this period and since then he has delivered over 100 Tripod Beta courses in more than 25 locations around the world. He is a Chartered Engineer, a member of the Institution of Engineering and Technology and holds a postgraduate diploma from the University of Birmingham (UK). POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations

The IPAF operator course instructs a candidate to prepare and safely operate various types of MEWPs, also referred to as cherry pickers, aerial lifts or scissor lifts. Categories include Static Vertical (1a), Static Boom (1b), Mobile Vertical (3a), Mobile Boom (3b), Specialist Machines (SPECIAL), Push Around Vehicle (PAV), Insulated Aerial Device (IAD).Categories include Static Vertical (1a), Static Boom (1b), Mobile Vertical (3a), Mobile Boom (3b),

Disciplined Agile Senior Scrum Master (DASSM): In-House Training Do you want to take Disciplined Agile® to a new level? Are you looking for tools to solve complex problems and enhance your organization's agility? Do you want to learn how to lead your team to excellence? Expand your knowledge and build practical skills around Disciplined Agile®, business agility, leadership, and team development. Disciplined Agile Senior Scrum Master is a nine-lesson, instructor-led course that shows you how to use the Disciplined Agile tool kit to solve a variety of advanced problems, work with allies within your organization, and optimize how teams work. You will gain knowledge in planning, reporting and metrics, and coordinating activities, as well as how to meet challenges in these areas. And you'll develop the skills you need to foster emotional intelligence, resolve conflicts, and lead high-performance teams at any stage of development. Filled with activities, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Senior Scrum Master (DASSM) exam and, equally important, start using Disciplined Agile immediately within your leadership role. What You Will Learn After the completion of this course, you will be able to: Accelerate your ability to lead high-profile initiatives that are critical to enterprise success Take a deep dive into the Disciplined Agile® tool kit to develop a comprehensive understanding of the hundreds of practices and strategies it contains and the trade-offs of applying them Apply the Disciplined Agile tool kit in hands-on exercises to guide your team in choosing and evolving your best way of working (WoW) in real-life situations Use the tool kit to solve complex challenges commonly encountered in development and operational teams, the value stream, and at the enterprise level Learn how to design and implement metrics that measure your improvements in areas where your teams are struggling Understand how to nurture emotional intelligence Feel confident empowering others on your team(s) Learn how to lead your teams in any situation to improve value delivery for your customers Apply the Disciplined Agile tool kit to guide your team in choosing and evolving the best way of working (WoW) in the situation you face Be prepared to take the Disciplined Agile® Senior Scrum Master (DASSM) exam and earn a valuable, credible certification Roles and responsibilities of DASSM Tuckman Team Development Model Emotional intelligence and why it is essential to team performance Business agility Tactical scaling factors in more complex situations Disciplined DevOps layer 'Test-first' method as it relates to the quality of requirements Scope and purpose of the value stream layer Coordinate activities process goal and why it is important Value creation structure of teams DA™ tool kit to optimize the flow of work and solve challenges related to coordinating and collaborating across teams, or within a larger team of teams Thomas-Kilmann Conflict Resolution Planning Five levels of scope Metrics

Certified Associate in Project Management (CAPM)® Exam Prep: In-House Training: In-House Training This course gives you the knowledge you need to pass the exam and covers CAPM®-critical information on project management theory, principles, techniques, and methods Are you planning on taking the CAPM® examination? This course gives you the knowledge you need to pass the exam and covers CAPM®-critical information on project management theory, principles, techniques, and methods. You'll also have an opportunity for practical applications and time to review the kinds of questions you'll find in the CAPM® Exam. What you Will Learn Apply for the CAPM® Examination Develop a personal exam preparation plan Describe the structure, intent, and framework principles of the current edition of the PMBOK® Guide Explain the PMBOK® Guide Knowledge Areas, as well as their inter-relationships with the each other and the Process Groups Getting Started Program orientation The CAPM® certification process Certified Associate in Project Management (CAPM®) Examination Content Outline CAPM® eligibility requirements Code of Ethics and Professional Conduct Application options Foundation Concepts Skills and qualities of a project manager Project management terminology and definitions Relationship of project, program, portfolio, and operations management Project lifecycle approaches Project Integration Management Review Project Integration Management Knowledge Area Develop Project Charter Develop Project Management Plan Direct and Manage Project Work Manage Project Knowledge Monitoring and Controlling Perform Integrated Change Control Close Project or Phase Project Stakeholder Management Review Project Stakeholder Management Knowledge Area Identify Stakeholders Plan Stakeholder Engagement Manage Stakeholder Engagement Monitor Stakeholder Engagement Project Scope Management Review Project Scope Management Knowledge Area Plan Scope Management Collect Requirements Define Scope Create WBS Validate Scope Control Scope Project Schedule Management Review Project Schedule Management Knowledge Area Plan Schedule Management Define Activities Sequence Activities Estimate Activity Durations Develop Schedule Control Schedule Project Cost Management Review Project Cost Management Knowledge Area Plan Cost Management Estimate Costs Determine Budget Control Schedule Project Resource Management Review Project Resource Management Knowledge Area Plan Resource Management Estimate Activity Resources Acquire Resources Develop Team Manage Team Control Resources Project Quality Management Review Project Quality Management Knowledge Area Plan Quality Management Manage Quality Control Quality Project Risk Management Review Project Risk Management Knowledge Area Plan Risk Management Identify Risks Perform Qualitative Risk Analysis Perform Quantitative Risk Analysis Plan Risk Responses Implement Risk Responses Monitor Risks Project Communications Management Review Project Communications Management Knowledge Area Plan Communications Management Manage Communications Monitor Communications Project Procurement Management Review Project Procurement Management Knowledge Area Plan Procurement Management Conduct Procurements Control Procurements Summary and Next Steps Program Review Mock CAPM® Exam Getting Prepared for the CAPM® Exam After the CAPM® Exam

Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 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 14 Points Development Level Learn

This course is designed to provide operatives with thorough theory and practical training in the role of the piling rig attendant.

Level 6 NVQ Diploma in Construction Site Management

This course will enable you to bring value to the business by putting data science concepts into practice. Data is crucial for understanding where the business is and where it's headed. Not only can data reveal insights, but it can also inform - by guiding decisions and influencing day-to-day operations.