The “ISO 42001:2023 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of an Artificial Intelligence Management System based on ISO 42001:2023. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective Artificial Intelligence management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 42001 standard.
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
Project Quality Management In today's environment, quality is the responsibility of everyone. Project success is no longer just the fulfillment of a project on schedule, on budget, and within the scope. Today, projects aren't successful unless the customer's needs are met at the highest level of quality at the lowest cost to the organization. Project Managers must know customer needs, and manage to them throughout the project lifecycle, in order to gain acceptance. Project Quality Management provides an interactive, hands-on environment for participants to practice identification of critical quality requirements (quality planning), fulfillment of those requirements through well-designed processes (Quality Assurance), and statistical awareness of technical specifications of project deliverables (Quality Control). What You Will Learn You'll learn how to: Plan for higher quality project deliverables Measure key performance indicators on projects, processes, and products Turn data into useful project information Take action on analyzed data that will drive down non-value-added costs and drive up customer acceptance and satisfaction Reduce defects and waste in current project management processes Foundation Concepts Quality Defined Customer Focus Financial Focus Quality Management Process Management Cost of Quality Planning for Quality Project Manager Role in Planning Voice of the Customer Quality Management Plan Measurement System Accuracy Data Gathering Data Sampling Manage Quality Process Management Process Mapping Process Analysis Value Stream Mapping Standardization Visual Workplace and 5S Error Proofing (Poka-Yoke) Failure Mode and Effect Analysis Control Quality The Concept of Variation Common Cause Special Cause Standard Business Reports Tracking Key Measurements Control Charts Data Analysis Variation Root Cause Analysis Variance Management Designing for Quality
Project Quality Management: In-House Training In today's environment, quality is the responsibility of everyone. Project success is no longer just the fulfillment of a project on schedule, on budget, and within the scope. Today, projects aren't successful unless the customer's needs are met at the highest level of quality at the lowest cost to the organization. Project Managers must know customer needs, and manage to them throughout the project lifecycle, in order to gain acceptance. Project Quality Management provides an interactive, hands-on environment for participants to practice identification of critical quality requirements (quality planning), fulfillment of those requirements through well-designed processes (Quality Assurance), and statistical awareness of technical specifications of project deliverables (Quality Control). What You Will Learn You'll learn how to: Plan for higher quality project deliverables Measure key performance indicators on projects, processes, and products Turn data into useful project information Take action on analyzed data that will drive down non-value-added costs and drive up customer acceptance and satisfaction Reduce defects and waste in current project management processes Foundation Concepts Quality Defined Customer Focus Financial Focus Quality Management Process Management Cost of Quality Planning for Quality Project Manager Role in Planning Voice of the Customer Quality Management Plan Measurement System Accuracy Data Gathering Data Sampling Manage Quality Process Management Process Mapping Process Analysis Value Stream Mapping Standardization Visual Workplace and 5S Error Proofing (Poka-Yoke) Failure Mode and Effect Analysis Control Quality The Concept of Variation Common Cause Special Cause Standard Business Reports Tracking Key Measurements Control Charts Data Analysis Variation Root Cause Analysis Variance Management Designing for Quality
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
Join the Historical Association and the Royal Geographical Society at this special online twilight forum event specifically for primary teachers of history and geography. The theme this time will be climate education and how primary teachers can develop this through their history and geography lessons. With a keynote speaker and workshop sessions from Ailsa Fidler and Emma Espley, plus an opportunity to network and share ideas, this event will support primary teachers to better understand how history and geography can feed into the responsibility of every curriculum subject to educate our young people about the climate crisis and sustainable futures.
PRINCE2® Foundation and Practitioner are process-based project management approaches that can be easily customised and scaled. PRINCE2® Foundation and Practitioner course aim to provide delegates with a comprehensive knowledge of project management methodologies. Course Overview PRINCE2 Foundation and Practitioner are process-based project management approaches that can be easily customised and scaled. PRINCE2® Foundation and Practitioner course aim to provide delegates with a comprehensive knowledge of project management methodologies. At the end of this PRINCE2® Foundation and Practitioner course, delegates will be able to delegate tolerances and report actual and forecast progress effectively. They will also be able to quickly prepare the risk management, change control, quality management, and communication management approaches. Attaining this PRINCE2® certification enables candidates to demonstrate and enhance their project management proficiency – contributing to elevated business acumen and career prospects. Concepts covered: • Project management • Levels of management • Authorise initiation • Tailoring the IP process • Project and stage plans • Analysing risks to a plan • Escalate issues and risks PRINCE2® Foundation Training: This introductory PRINCE2® certification will help candidates understand the fundamentals of the PRINCE2® project management methodology and develop an appreciation of the constituents that contribute to a project’s success – underpinned by the PRINCE2® principles, processes, and themes. The foundation element of the combined course lasts for 3 days. During the course, candidates will gain a basic understanding of how to work in part of a PRINCE2® team. PRINCE2® Practitioner Training: The PRINCE2® Practitioner element of the combined course forms the final part of the training where the candidate learns to apply their acquired knowledge. Candidates will be educated on how to apply the methodology to a set of scenarios and how to efficaciously lead a project. What’s Included in this PRINCE2® Course? The following is included in this PRINCE2® Course: • The PRINCE2® Foundation Examination • The PRINCE2® Practitioner Examination • Pre-course material • PRINCE2® Workbook • PDUs • Experienced PRINCE2® Instructor • Certificate • Refreshments • PRINCE2 Homework – Set by your PRINCE2 Instructor at the end of each day. Prerequisites for PRINCE2® Course: In this PRINCE2® Foundation and Practitioner course, there are no formal prerequisites. This PRINCE2® Course is designed for anyone who wants to gain in-depth knowledge about project management methodologies. This Course is more beneficial for: • Project Managers • Aspiring Project Managers • Team Leaders • Directors • Senior Responsible Owners PRINCE2® Foundation and Practitioner 6th Edition Training Course Outline: Module 1: Introduction to Projects and the PRINCE2® Methodology: • PRINCE2® “Project” Definition • Project Characteristics • Project Management • What is PRINCE2®? • Four Integrated Elements • What PRINCE2® Does Not Provide • What Makes a Project a PRINCE2® Project? Module 2: Project Manager Activities: • Customer/Supplier Environment • Projects in Context • Commercial Environment • Applying PRINCE2® • Delivery Approaches • Measuring Success • Organisational Capability • Seven Processes Module 3: Seven Themes: • Business Case • Organisation • Quality • Plans • Risk • Change • Progress Module 4: Seven Principles: • Continued Business Justification • Learn from Experience • Defined Roles and Responsibilities • Manage by Stages • Manage by Exception • Focus on Products • Tailor to Suit the Project Module 5: Organisation Theme: • Four Levels of Management • PRINCE2® Organisation Requirements • Project Management Team • Project Management Team Roles • Project Board • Project Assurance • Change Authority • Project Support • Communication Management Approach Module 6: Starting Up a Project (SU): • Process Overview • Feasibility Study and Mandate • Appoint the Executive and the Project Manager • Capture Previous Lessons • Design and Appoint the Project Management Team • Prepare the Outline Business Case • Project Product Description • Select the Project Approach and Assemble the Project Brief • Plan the Initiation Stage • Tailoring the SU Process Module 7: Directing a Project (DP): • Authorise Initiation • Authorise the Project • Authorise a Stage or Exception Plan • Authorise Project Closure • Give Ad Hoc Direction • Tailoring the DP Process • Theme Overview • Balance of Justification • Continued Business Justification • PRINCE2® Requirements • Contents of a Business Case • Business Case Development • Benefits Management Approach • Key Responsibilities Module 8: Initiating a Project (IP): • Agree to the Tailoring Requirements • Prepare the Risk Management Approach • Prepare the Change Control Approach • Prepare the Quality Management Approach • Prepare the Communication Management Approach • Set up the Project Controls • Create the Project Plan • Prepare the Benefits Management Approach • Assemble the Project Initiation Documentation • Tailoring the IP Process Module 9: Risk Theme: • Risk Definition • Effective Risk Management • PRINCE2® Risk Requirements • Risk Management Approach • Probability/Impact Grid • Risk Register • Risk Management Procedure • Identify Step • Risk Budget • Key Responsibilities Module 10: Quality Theme: • Quality Definitions • Quality Management • Quality Planning and Control • What is Quality Assurance? • PRINCE2® Quality Requirements • PRINCE2® Quality Documentation Requirements • Quality Management Approach • Quality Audit Trail • Project Product Description • Product Description • Quality Review Technique • Quality Review Roles/Responsibilities • Quality Review Meeting • Off-Specifications and Concessions • Review Follow-Up • Quality Review Benefits • Key Responsibilities • Communication Management Approach Module 11: Plans Theme: • Dealing with the Planning Horizon • PRINCE2® Planning Requirements • Documentation Requirements • Project and Stage Plans • Team Plans and Work Packages • Plans Relationship • What is in a Plan? • PRINCE2® Approach to Plans • Designing a Plan • Delivery Approaches • Defining and Analysing the Products • Product Breakdown Structures • Product Description • Product Flow Diagram • Identify the Activities and Dependencies • Preparing Estimates • Preparing a Schedule • Documenting the Plan • Analysing Risks to a Plan • Gantt Chart and Tailoring • Key Responsibilities Module 12: Progress Theme: • Progress Definition • PRINCE2® Requirements • Progress Control • Management by Exception • Delegating Tolerances and Reporting Actual and Forecast Progress • Types of Control • Management Products and Progress Control Module 13: Change Theme: • Issue Definition • PRINCE2® Approach to Change • PRINCE2® Change Documentation • Issue Register • Change Control Approach • Change Budget • Issue and Change Control Procedure • Issue Report • Exception Report Module 14: Controlling a Stage (CS): • Activity Breakdown • Authorise a Work Package • Work Package • Review Work Package Status • Receive Completed Work Packages • Review the Management Stage Status • Report Highlights • Highlight Report • Capture and Assess Issues and Risks • Escalate Issues and Risks • Take Corrective Action • Tailoring CS Module 15: Managing Product Delivery (MP): • Accept a Work Package • Execute a Work Package • Checkpoint Report • Deliver a Work Package • Tailoring MP Module 16: Managing a Stage Boundary (SB): • Plan the Next Management Stage • What is in a Plan? • Update the Project Plan • Update the Business Case • Report the Management Stage End • End-Stage Report • Produce an Exception Plan • Tailoring SB Module 17: Closing a Project (CP): • Prepare Planned Closure • Hand Over Products • Evaluate the Project • End Project Report • Recommend Project Closure • Tailoring CP Module 18: Considerations for Organisational Adoption: • Creating a PRINCE2® Based Project Management Method • Creating Tailoring Rules and Guidelines • Rating the Complexity of Projects • Embedding PRINCE2® • Tailoring • What Should Be Tailored? • Tailoring Constraints and Influences • Creating an Organisation’s Method DURATION 6 days WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate
About this Virtual Instructor Led Training (VILT) Accredited by the United Kingdom Lubricants Association (UKLA), this 4 half-day Virtual Instructor Led Training (VILT) course will provide an in-depth understanding of the principles, economics and flexibility of lubricant blending plants and how to operate a lubricants blending plant efficiently and economically. The latest developments and trends in lubricant blending and the advantages and disadvantages of lubricant blending equipment, facilities and operations will be discussed. The importance of testing components and products for each blend, lubricant blend quality control and product quality management will also be explained. The VILT course will also clarify the importance of lubricant product filling, packaging and warehouse storage, strategies for optimising existing lubricant blending plant facilities and how to avoid or minimise problems with lubricant blending and product quality. The VILT course is recognised under the UKLA Continuing Professional Development (CPD) scheme for Registered Lubricant Professional. *There will be an examination for this VILT. Training Objectives This VILT course will enable you to: Learn about Mineral Oil Base Oils; API Groups I, II and III: Properties and Characteristics Acquire the knowledge about Synthetic Base Oils; API Groups IV and V: Properties and Characteristics Learn about Lubricant Additives: Properties and Characteristics Know the Lubricant Formulation and Ease of Blending Explore the Blending Plant Design: Grassroots Plants and Upgrading Existing Plants Learn about Blending Plant Equipment and Facilities and Their Operation Understand the Lubricant Blending Issues: Avoiding Problems Test and Analyse Base Oils and Additives Test and Analyse Blended Lubricants Explore the importance of Product Quality Control Understand the process of Lubricant Packaging and Filling Understand the process of Lubricant Storage Learn about Product Quality Management Target Audience This VILT course will be useful and applicable for: Middle and Senior managers to understand how and why to design and operate an efficient and profitable lubricant blending plant. Blending plant operators and specialists to improve and optimise current blending plant operations. Manufacturers of lubricants will understand how and why high quality components and effective testing during the entire blending process are important to final lubricant product quality and performance. Lubricant formulators will understand the importance of close communication and co-operation with blending plant managers and operators to minimise blending costs and to thereby maximise product profitability. Course Level Intermediate Training Methods The VILT course will be delivered online in 4 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. Course Duration: 4 half-day sessions, 4 hours per session (16 hours in total). Trainer Your expert course leader (CChem, MRC) has worked as Sales, Technical Marketing Manager and Company Director with over 50 years of broad experience in the lubricants, fuels, petroleum additives, with four leading companies Chevron, Ethyl Petroleum Additives Ltd, Texaco Limited and Kuwait Petroleum (GB) Ltd. His major recent responsibilities have been concerned with leading the Oil Industry Association United Kingdom Lubricants Association, and acting in an advisory capacity as Technical Director to the Association. He has acquired a wide experience in technical, marketing and sales within the oil industry. The related experience gained with the oil additives industry has provided him with special additional insights. He has also led the Certificate of Lubricant Competence course for the United Kingdom Lubricants Association (UKLA) for 11 years. He is a Chartered Chemist and a Member of the Royal Society of Chemistry. 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 about post training coaching support and fees applicable for this. Accreditions And Affliations
All organizations have policies and procedures that guide how decisions are made and how the work is done in that organization. Professionally written policies and procedures increase organizational accountability and transparency and are fundamental to quality/standards assurance and quality improvement.