59 Quality Assurance (QA) courses in Belfast delivered Live Online

About this Training Subsea pipelines play a critical role in the transportation of hydrocarbons (e.g. oil and gas) from offshore production sites to onshore facilities or other platforms. This course will cover design and construction of subsea pipelines with respect to: design for pressure containment, design for collapse, on-bottom stability, freespans, global (lateral and upheaval buckling), corrosion, materials selection, cathodic protection and coatings. Training Objectives Upon completion of this course, participants will be able to understand: Issues and challenges in subsea pipeline design Methods in applying pipeline design codes Techniques in how to specify a pipeline Key considerations in the main methods of pipeline construction Methods and issues surrounding pipeline intervention Target Audience The course is recommended for anyone who wish to gain in-depth knowledge and appreciation of the fundamental principles of the design and construction of subsea pipelines, including: Team Leaders Senior Managers (Line and Function) Project Managers Graduate Engineers Pipeline Engineers Senior Pipeline Engineers Subsea Engineers Integrity Engineers Quality Assurance Engineers Key Contractor's Management Course Level Basic or Foundation Trainer Your expert course leader is a subsea pipeline consultant with extensive experience in the design, construction, and installation of subsea pipelines for the oil and gas industry. As a consultant, he provides technical expertise and support to clients on all aspects of subsea pipeline projects, from the initial planning and design phase through to construction and commissioning. He is knowledgeable about industry standards, regulations, and best practices for subsea pipelines, and works closely with clients to ensure that projects are delivered safely, on time, and within budget. He has over thirty years' experience in early concept and front-end studies for the initiation of numerous high value upstream oil and gas projects worldwide. He has worked for both Operating Companies and Consultants managing the FEL process for complex, multi-discipline and technically challenging concepts, combining both his technical and project management skills. He has been working with companies like ExxonMobil, Quantum Power, North Caspian Operating Company, OMV Petrom, Port Meridian, BG Group, and etc. 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

About this Virtual Instructor Led Training (VILT)  A decision to drill an exploration well with the objective to find a new oil or gas field must be based on sound assessment of the prospect risk and of the volumes. What is the chance that a well will find hydrocarbons, and how much could it be? Risk and volume assessments form the basis for decisions to drill a well or not, and as such form the link between subsurface evaluation and the business aspects of the petroleum industry. This Virtual Instructor Led Training (VILT) course explains how risks and volumes can be assessed in a realistic manner, based on a sound understanding of the geological details of the prospect as well as its regional geological setting and current play understanding. Participants of this VILT course will receive a softcopy of Risk and Volume Assessment Handbook which explains the concepts that are associated with probabilistic Risk & Volume (R & V) Assessment and contains many practical recommendations on how to translate geological understanding into meaningful inputs for probabilistic R &V assessments. The book is fully compatible with any probabilistic R & V tool in the industry. Training Objectives By the end of this VILT course, participants will be able to understand: The fundamentals of risk and volumes assessment; translating geological understanding into reasonable numbers and ranges. The difference between risk and uncertainty. Fundamentals of statistics; including explanation of distribution curves, understanding of expectation curves, do's and don'ts for adding risked volumes, and Bayes theorem. Uncertainty of trap, reservoir, seal and charge, illustrated by examples. Guidelines and exercises for estimating risks realistically and consistently. Calculating volume ranges for prospects and for portfolios of prospects; how to add prospect volumes for a correct representation of prospect portfolios. Incorporation of geophysical evidence (DHIs) in a realistic risk assessment. Target Audience This VILT course has been designed in the first place for geoscientists working in exploration, for prospect portfolio analysts and for their direct supervisors. It will also benefit staff from disciplines working closely with exploration staff, such as reservoir engineers, petrophysicists and geophysicists. Course Level Intermediate Training Methods Learning, methods and tools The VILT course will be delivered online in 5 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. It is the intention to have at least 2 smaller exercises per day. Time will be reserved for recapitulation, questions and discussions. VILT will be conducted either via Zoom or Microsoft Teams. Presenting materials can easily be done on this platform. When participants need to ask a question, they can raise their hand, write notes or interrupt the Instructor by using their microphone. The presenter can switch to a screen where he/she can see all participants (also when each participant is sitting in another location e.g. at home). There is also a whiteboard functionality that can be used as one would use a flip chart. Exercises will be done on an online platform which provides each participant with a private work area that can be accessed by the Instructor to discuss the exercise in a similar manner as in a classroom course. Each topic is introduced by a lecture, and learning is re-enforced by practical exercises and discussions. Handout material in electronic format will be provided. Trainer Dr. Jan de Jager has a PhD in Geology from the University of Utrecht. He joined Shell in 1979 as an exploration geologist, and worked in several locations around the world such as Netherlands, Gabon, USA, Australia, Argentina, and Malaysia in technical and management positions. During the last 10 years of his career, he was responsible for the quality assurance of Shell's exploration prospects in many parts of the world and for upgrading and replenishing Shell's global exploration portfolio. During this period, he had also developed extensive expertise in Prospect Risk and Volume assessments for which he ran successful internal training programmes. Following his retirement from Shell in 2010, Dr Jan de Jager took on a position as part-time professor at the University of Amsterdam and also serves as a consultant exploration advisor for various E&P companies. 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

Duration 2 Days 12 CPD hours This course is intended for The primary audiences for this course are quality directors and quality assurance managers, managers responsible for the governance of an enterprise and management of its risks, technical experts, project managers and consultants, internal auditors, compliance officers and virtually anybody involved in ANSI/TIA-942 compliance certification related projects either from an end-user or vendor perspective. Participants must hold a valid CTDC certificate in order to be able to register for the CTIA class. Overview After completion of the course the participant will be able to: 1. Prepare the organisation for an audit according to ANSI/TIA-942 including preparation of the required documents, resource planning and management of the audit process itself 2. Conduct an internal audit according to ANSI/TIA-942 following ISO-19011 guidelines 3. Facilitate and support the external audit to ANSI/TIA-942 4. Manage the post-audit process with respect to CAR (Corrective Action Reports), gap closing and _nal certification 5. Facilitate surveillance and recertification audits This intensive course builds further on the technical understanding of the standard acquired in the CTDC© (Certified TIA-942 Design Consultant) course. Fundamental concepts and process of an internal audit Terms and de_nitions Difference between an internal and external auditor Audit principles Auditor competency requirements Managing an audit programme Establishing the audit objectives Establishing the audit programme Planning the audit Planning the schedule Resource planning Tools/equipment required Document requirements - Design documents - Process documents - Declarations Conducting the audit Conducting an opening meeting Conducting the audit Interviews Document review Facility review Typical non-conformities - Architectura - Electrica - Mechanical - Telecommunications Preparing the audit conclusions Conducting the closing meeting Preparing and distributing the audit report Audit report requirements Classification of non-conformities Typical format of an audit report Following up on the audit The CAR ? Corrective Action Report Evaluation of the Corrective Action Report Requesting a formal external auditIssuing a conformity certificate Requirements of the certificate Registration of the certificate Surveillance auditsRecertification auditsExam: Certified TIA-942 Internal Auditor) Actual course outline may vary depending on offering center. Contact your sales representative for more information. Additional course details: Nexus Humans Certified TIA-942 Internal Auditor (CTIA) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Certified TIA-942 Internal Auditor (CTIA) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Duration 2 Days 12 CPD hours This course is intended for The target audience for the DevSecOps Foundation course are professionals including: Anyone involved or interested in learning about DevSecOps strategies and automation Anyone involved in Continuous Delivery toolchain architectures Compliance Team Business managers Delivery Staff DevOps Engineers IT Managers IT Security Professionals, Practitioners, and Managers Maintenance and support staff Managed Service Providers Project & Product Managers Quality Assurance Teams Release Managers Scrum Masters Site Reliability Engineers Software Engineers Testers Overview You will learn: The purpose, benefits, concepts, and vocabulary of DevSecOps How DevOps security practices differ from other security approaches Business-driven security strategies and Best Practices Understanding and applying data and security sciences Integrating corporate stakeholders into DevSecOps Practices Enhancing communication between Dev, Sec, and Ops teams How DevSecOps roles fit with a DevOps culture and organization In this course, students will gain a solid understanding of how DevSecOps provides business value, enhancing your business opportunities, and improving corporate value. The core DevSecOps principles taught can support an organizational transformation, increase productivity, reduce risk, and optimize resource usage. This course explains how DevOps security practices differ from other approaches then delivers the education needed to apply changes to your organization. Participants learn the purpose, benefits, concepts, vocabulary and applications of DevSecOps. Most importantly, students learn how DevSecOps roles fit with a DevOps culture and organization. At the course?s end, participants will understand ?security as code? to make security and compliance value consumable as a service. This course prepares you for the DevSecOps Foundation (DSOF) certification. Realizing DevSecOps Outcomes Origins of DevOps Evolution of DevSecOps CALMS The Three Ways Defining the Cyberthreat Landscape What is the Cyber Threat Landscape? What is the threat? What do we protect from? What do we protect, and why? How do I talk to security? Building a Responsive DevSecOps Model Demonstrate Model Technical, business and human outcomes What?s being measured? Gating and thresholding Integrating DevSecOps Stakeholders The DevSecOps State of Mind The DevSecOps Stakeholders What?s at stake for who? Participating in the DevSecOps model Establishing DevSecOps Best Practices Start where you are Integrating people, process and technology and governance DevSecOps operating model Communication practices and boundaries Focusing on outcomes Best Practices to get Started The Three Ways Identifying target states Value stream-centric thinking DevOps Pipelines and Continuous Compliance The goal of a DevOps pipeline Why continuous compliance is important Archetypes and reference architectures Coordinating DevOps Pipeline construction DevSecOps tool categories, types and examples Learning Using Outcomes Security Training Options Training as Policy Experiential Learning Cross-Skilling The DevSecOps Collective Body of Knowledge Preparing for the DevSecOps Foundation certification exam Additional course details: Nexus Humans DevSecOps Foundation (DevOps Institute) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the DevSecOps Foundation (DevOps Institute) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

PRINCE2® Foundation: In-House Training Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends

PRINCE2® Foundation: Virtual In-House Training Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends

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

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

ISO 7101 Healthcare Quality Management System Lead Auditor Course provides participants with the knowledge and skills necessary to lead audits of quality management systems within healthcare organizations. This comprehensive training program covers the principles, processes, and practices of auditing healthcare quality management systems, focusing on key standards and regulations applicable to the healthcare industry.

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