14 Process Mapping courses delivered Live Online

Course Information This course aims to empower you with the expertise to proficiently navigate process mapping and master the art of crafting Standard Operating Procedures (SOPs) within regulated environments. Whether you're engaged in activities that demand process improvement, continual enhancement, or SOP creation, this course offers invaluable insights tailored to your needs. It caters to individuals tasked with managing, documenting, and implementing processes and SOPs, irrespective of prior experience or skills. Our curriculum does not focus on specific software or approaches, focusing instead on fundamental principles and adaptable concepts applicable across diverse organisational landscapes. Benefits include: Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. This course is structured to encourage delegates to:  Discuss and develop ideas Develop a practical approach for creating process maps and writing SOPs Understand how to use process maps in SOPs effectively Discuss how process mapping for preparing SOPs can be applied to process improvement for SOPs. Is this course for you? The course is designed for all those with responsibility for managing, documenting and implementing processes and SOPs. It assumes no prior experience or skills. The course does not recommend any specific software or approach, but explores the principles and ideas that can be applied in any organisation. What will you learn? Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. By the end of the course you will be able to: Create process maps and write clearer more concise SOPs Understand how to use process maps in SOPs effectively Understand how process mapping can be applied to process improvement and better SOPs. Tutors Tutors will be comprised of (click the photos for biographies): Laura Brown Director, Laura Brown Training and Development David Butler VP of Quality, Resolian Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introductions and Course Objectives Why Companies manage by process. 10:00 Exercise 1 - First Steps Mechanisms for process mapping, levels at which it can be applied, and the roles and responsibilities of process owners. 10:30 Exercise 1 - Feedback 10:45 Break 11:00 Mapping Processes The stages involved in mapping processes including how to construct a SIPOC chart. 11:45 Exercise 2 - Mapping A Process A first opportunity to practice your new process mapping skills. 12:30 Exercise 2 - Feedback 13:00 Lunch 14:00 Exercise 3 - Discussion of Options for Format, Structure and Layout What Makes A Good SOP? Discussion of options for format, structure, level of detail of SOPs and the use of process maps for SOP writing. A case study example of a good SOP which uses a flow chart/process map. 14:45 Exercise 3 - Feedback 15:00 Break 15:15 A Case Study example of a good SOP that uses a flow chart / process map 15:30 Exercise 4 Discussion of the content of an SOP using a Process Map 15:35 Exercise 4 - Feedback 15:45 Key Writing Considerations 16:15 Exercise 5 16:45 Exercise 5 - Feedback 17:00 Close of Day Day 2 09:00 Review of Day 1 09:15 Using Metrics Selecting and using metrics to monitor and improve processes. 10:00 Exercise 6 - Practice in Process Mapping Creating Process Maps from multi-source information. 11:00 Break 11:15 Exercise 6 - Feedback 11:45 Common Pitfalls Common problems and tips for good Process Mapping. 12:15 Demonstration of Process Mapping on a PC 12:45 Lunch 13:30 Exercise 7 - Mind Mapping 14:30 Exercise 7 - Feedback 15:00 Break 15:15 Exercise 8 - Using Process Maps to Write an SOP Applying your process mapping skills as part of writing an SOP 15:30 Exercise 8 - Feedback 15:45 Course Review and Follow-up 16:00 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. Development Level Learn

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

Project Quality Management: Virtual 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

Duration 2 Days 12 CPD hours This course is intended for Project Managers, Business Analysts, Business and IT stakeholders working with analysts Overview Provide a solid foundation for applying business process modeling principles and best practices with BPMN Demonstrate how to solve practical business problems using BPMN Business Process Diagrams (BPDs) Students will learn to map business processes easily and efficiently using the industry standard - BPMN which stands for Business Process Modeling Notation from the Object Management Group (OMG). Students will learn the best practices in process mapping using the latest industry standards (BPMN) so that both the business and IT stakeholders will be able to understand the models and map processes consistently through-out their organization. Introduction What is Business Process Modeling? What is Business Process Modeling Notation (BPMN)? Benefits of BPMN An Overview of Governance An overview of governance Key governance questions to ask What happens if you don?t have effective governance? Mapping the Business Problem Define a strategic outcomes map Define a Business model and relevant processes Modeling Simple BPMN Structures When do you use BPMN? What are simple BPMN structures? AS-IS vs. TO-BE modeling Modeling Complex BPMN Structures What are complex BPMN structures When to use complex BPMN structures Analyzing Process Models Identifying poor process models Creating process models that everyone can understand Identify criteria for a well-defined process Process Mapping vs. Process Modeling Determine when to create a process map Determine when to create a process model Asking the four ?Ares? Additional Resources Learning about BPMN 2.0 More useful BPMN links BPMN 2.0 free editors

Lean Six Sigma Green Belt Certification Program: In-House Training This learning series is designed to enable participants to fulfill the important role of a Lean Six Sigma Green Belt and to incorporate the Lean Six Sigma mindset into their leadership skills. Green Belt is not just a role, it is also a competency required for leadership positions at many top companies. This learning series is designed to enable participants to fulfill the important role of a Lean Six Sigma Green Belt and to incorporate the Lean Six Sigma mindset into their leadership skills. With a real-world project focus, the series will teach the fundamental methodology, tools, and techniques of the Define, Measure, Analyze, Improve and Control Process Improvement Methodology. This course is delivered through sixteen 3-hour online sessions. What you Will Learn At the end of this program, you will be able to: Identify strategies for effectively leading high performing process improvement teams Analyze whether projects align with business strategy Apply process improvement methodologies to DMAIC steps, based on real world scenarios Explain ways to appropriately respond to process variation Distinguish among best practice problem solving methodologies Evaluate and effectively communicate data-driven decisions, based on real world scenarios Introduction Lean Six Sigma & quality The vision The methodologies The metric Project Selection Why Projects Random idea generation Targeted idea generation CTQs (Critical to Quality) & projects Project screening criteria Quick improvements Introduction to Define Project Planning Developing the core charter Developing a project charter Facilitation Process Management Business process management Top-down process mapping Voice of the Customer Voice of Customer Stakeholder analysis Communication planning Kicking off the project Define Summary Introduction to Measure Data Collection Fact-based decision making Data sampling Operations definitions Data collection plan Measurement system analysis Graphical Statistics for Continuous Data Meet Six SigmaXL Graphical & statistical tools Data stratification Graphical Statistics for Discrete Data Pareto analysis Dot plots Plotting data over time: Looking for patterns Variation Concepts Variation is reality Special Cause and Common Cause variation Example of standard business reporting Individuals Control Chart Process Capability Genesis of process capability Calculating the metrics of Six Sigma Yield metrics: Measuring process efficiency Cost of Poor Quality The Cost of Poor Quality (COPQ) Cost of Quality categories Calculating the Cost of Poor Quality Measure Summary Introduction to Analyze Process Analysis Introduction to process analysis Value-added analysis Cycle time analysis WIP & pull systems Analyzing bottlenecks and constraints Cause & Effect Analysis Fishbone/Ishikawa diagram 5-Whys analysis Graphical & statistical tools Advanced Analysis Why use hypothesis rests? Hypothesis tests Correlation and regression analysis Analyze Summary Introduction to Improve Solutions Creativity techniques Generating alternative solutions Solution selection techniques Introduction to Design of Experiments Introduction to DOE DOE activity Error Proofing Failure mode & effect analysis Poka-Yoke Project Management Fundamentals Successful teams Project roles Conflict management Standardization Standardization The Visual Workplace 5S Piloting & Verifying Results What is a pilot? Evaluating results Improve Summary Introduction to Control Statistical Process Control Review of Special & Common Cause variation Review of Individual Control Chart P-Chart for discrete proportion data Transition Planning Control plan Project closure Control Summary Summary and Next Steps

Lean Six Sigma Green Belt Certification Program: Virtual In-House Training This learning series is designed to enable participants to fulfill the important role of a Lean Six Sigma Green Belt and to incorporate the Lean Six Sigma mindset into their leadership skills. Green Belt is not just a role, it is also a competency required for leadership positions at many top companies. This learning series is designed to enable participants to fulfill the important role of a Lean Six Sigma Green Belt and to incorporate the Lean Six Sigma mindset into their leadership skills. With a real-world project focus, the series will teach the fundamental methodology, tools, and techniques of the Define, Measure, Analyze, Improve and Control Process Improvement Methodology. This course is delivered through sixteen 3-hour online sessions. What you Will Learn At the end of this program, you will be able to: Identify strategies for effectively leading high performing process improvement teams Analyze whether projects align with business strategy Apply process improvement methodologies to DMAIC steps, based on real world scenarios Explain ways to appropriately respond to process variation Distinguish among best practice problem solving methodologies Evaluate and effectively communicate data-driven decisions, based on real world scenarios Introduction Lean Six Sigma & quality The vision The methodologies The metric Project Selection Why Projects Random idea generation Targeted idea generation CTQs (Critical to Quality) & projects Project screening criteria Quick improvements Introduction to Define Project Planning Developing the core charter Developing a project charter Facilitation Process Management Business process management Top-down process mapping Voice of the Customer Voice of Customer Stakeholder analysis Communication planning Kicking off the project Define Summary Introduction to Measure Data Collection Fact-based decision making Data sampling Operations definitions Data collection plan Measurement system analysis Graphical Statistics for Continuous Data Meet Six SigmaXL Graphical & statistical tools Data stratification Graphical Statistics for Discrete Data Pareto analysis Dot plots Plotting data over time: Looking for patterns Variation Concepts Variation is reality Special Cause and Common Cause variation Example of standard business reporting Individuals Control Chart Process Capability Genesis of process capability Calculating the metrics of Six Sigma Yield metrics: Measuring process efficiency Cost of Poor Quality The Cost of Poor Quality (COPQ) Cost of Quality categories Calculating the Cost of Poor Quality Measure Summary Introduction to Analyze Process Analysis Introduction to process analysis Value-added analysis Cycle time analysis WIP & pull systems Analyzing bottlenecks and constraints Cause & Effect Analysis Fishbone/Ishikawa diagram 5-Whys analysis Graphical & statistical tools Advanced Analysis Why use hypothesis rests? Hypothesis tests Correlation and regression analysis Analyze Summary Introduction to Improve Solutions Creativity techniques Generating alternative solutions Solution selection techniques Introduction to Design of Experiments Introduction to DOE DOE activity Error Proofing Failure mode & effect analysis Poka-Yoke Project Management Fundamentals Successful teams Project roles Conflict management Standardization Standardization The Visual Workplace 5S Piloting & Verifying Results What is a pilot? Evaluating results Improve Summary Introduction to Control Statistical Process Control Review of Special & Common Cause variation Review of Individual Control Chart P-Chart for discrete proportion data Transition Planning Control plan Project closure Control Summary Summary and Next Steps

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.

Management of Value (MoV®) Foundation This interactive MoV® Foundation course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn Upon completion of an MoV course candidates should be able to discuss and explain: The main processes and techniques used within MoV and the reasons for using them How MoV may be applied at portfolio, program, project and operational levels The differences in applying MoV at different stages in a project and the expected outputs from a MoV Study at each stage The circumstances under which MoV should be used The concept of value and how value may be improved The main benefits arising from the use of MoV Approaches for implementing MoV How to respond to external and internal influences The principles of embedding MoV into an organization The key topics in document checklists, the toolbox, health check, organizational maturity and individual competence. Upon successful completion of this course, you will be able to: Organize and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach and environment Analyse a company, program or project to establish its organizational value; includes identification and weighting of Value Drivers Pass the AXELOS MoV Foundation Examination Introduction to value management and MoV Value and Value Management Capabilities, Outcomes, Benefits and Disbenefits What is Value? What is Management of Value (MoV)? Why use MoV? Where use MoV? When MoV should be used? What using MoV involve? Selected MoV benefits Relationship with other AXELOS Global Best Practices and Models How MoV fits with other AXELOS Global Best Practice Guides MoV principles Align with organization's objectives Focus on functions and required outcomes Balance the variables to maximise value Apply throughout the investment decision Tailor MoV to suit the subject Learn from experience and improve Assign clear roles and responsibilities and build a supportive culture MoV processes Frame the programme or project Gather information Analyse information Process information Evaluate and select Develop Value Improving Proposals Implement and share outputs MoV techniques Function Analysis Function Analysis System Technique (FAST) Traditional (or classic) FAST Technical FAST Customer FAST Value Trees Measuring value Value profiling (a.k.a. value benchmarking) Simple multi-attribute rating technique (a.k.a. SMART) Value index Value metrics Value for money (VfM) ratio Value Engineering / Analysis Common techniques used in MoV Analysis of information Benchmarking Process Mapping Root Cause Analysis Discounted Cash Flow Analysis Generating Ideas Brainstorming Evaluation and option selection Option Selection Matrix Idea selection Allocation to Categories Idea Selection Matrix Weighting techniques Paired Comparisons Points Distribution Developing VIPs Developing Proposals Cost Benefit Analysis Building Decisions Implementing VIPs Implementation Plans Feedback Following up Tracking Benefits Approach to Implementation Generic approach to MoV implementation Plan the MoV activities Understand and articulate value Prioritize value Improve value Quantify value Monitor improvements in value Learn lessons Environmental factors Portfolio Considerations Programme considerations Project considerations Operational Considerations Embedding MoV into an organization Benefits of Embedding MoV into an organization MoV Policy MoV Policy Composition Embedding MoV into an organisation Key steps Suggested MoV Management Structure Overcoming barriers We do it anyway It takes up too much time We can't afford to make the changes What's in it for me? Don't fix it if it ain't broke Fixed returns on investment MoV products Briefing Meeting Agenda (A.1) Communications Checklist (A.2) Equipment list for an Effective Study/Workshop (A.3) Invitation to join the Study Team (A.4) Option Evaluation Matrix (A.5) Plan the Study (A.6) Recording Idea Selection (A.7) Reporting Study outputs (A.8) Scoping the Study (A.9) Study or Workshop Handbook (A.10) Value-Improvement Proposal Forms (A.11) Value Improvement Tracking Report (A.12) MoV toolbox MoV health check and maturity model P3M3 Maturity Model MoV Maturity Model (aligned with P3M3)

Management of Value (MoV®) Foundation: Virtual In-House Training This interactive MoV® Foundation course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn Upon completion of an MoV course candidates should be able to discuss and explain: The main processes and techniques used within MoV and the reasons for using them How MoV may be applied at portfolio, program, project and operational levels The differences in applying MoV at different stages in a project and the expected outputs from a MoV Study at each stage The circumstances under which MoV should be used The concept of value and how value may be improved The main benefits arising from the use of MoV Approaches for implementing MoV How to respond to external and internal influences The principles of embedding MoV into an organization The key topics in document checklists, the toolbox, health check, organizational maturity and individual competence. Upon successful completion of this course, you will be able to: Organize and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach and environment Analyse a company, program or project to establish its organizational value; includes identification and weighting of Value Drivers Pass the AXELOS MoV Foundation Examination Introduction to value management and MoV Value and Value Management Capabilities, Outcomes, Benefits and Disbenefits What is Value? What is Management of Value (MoV)? Why use MoV? Where use MoV? When MoV should be used? What using MoV involve? Selected MoV benefits Relationship with other AXELOS Global Best Practices and Models How MoV fits with other AXELOS Global Best Practice Guides MoV principles Align with organization's objectives Focus on functions and required outcomes Balance the variables to maximise value Apply throughout the investment decision Tailor MoV to suit the subject Learn from experience and improve Assign clear roles and responsibilities and build a supportive culture MoV processes Frame the programme or project Gather information Analyse information Process information Evaluate and select Develop Value Improving Proposals Implement and share outputs MoV techniques Function Analysis Function Analysis System Technique (FAST) Traditional (or classic) FAST Technical FAST Customer FAST Value Trees Measuring value Value profiling (a.k.a. value benchmarking) Simple multi-attribute rating technique (a.k.a. SMART) Value index Value metrics Value for money (VfM) ratio Value Engineering / Analysis Common techniques used in MoV Analysis of information Benchmarking Process Mapping Root Cause Analysis Discounted Cash Flow Analysis Generating Ideas Brainstorming Evaluation and option selection Option Selection Matrix Idea selection Allocation to Categories Idea Selection Matrix Weighting techniques Paired Comparisons Points Distribution Developing VIPs Developing Proposals Cost Benefit Analysis Building Decisions Implementing VIPs Implementation Plans Feedback Following up Tracking Benefits Approach to Implementation Generic approach to MoV implementation Plan the MoV activities Understand and articulate value Prioritize value Improve value Quantify value Monitor improvements in value Learn lessons Environmental factors Portfolio Considerations Programme considerations Project considerations Operational Considerations Embedding MoV into an organization Benefits of Embedding MoV into an organization MoV Policy MoV Policy Composition Embedding MoV into an organisation Key steps Suggested MoV Management Structure Overcoming barriers We do it anyway It takes up too much time We can't afford to make the changes What's in it for me? Don't fix it if it ain't broke Fixed returns on investment MoV products Briefing Meeting Agenda (A.1) Communications Checklist (A.2) Equipment list for an Effective Study/Workshop (A.3) Invitation to join the Study Team (A.4) Option Evaluation Matrix (A.5) Plan the Study (A.6) Recording Idea Selection (A.7) Reporting Study outputs (A.8) Scoping the Study (A.9) Study or Workshop Handbook (A.10) Value-Improvement Proposal Forms (A.11) Value Improvement Tracking Report (A.12) MoV toolbox MoV health check and maturity model P3M3 Maturity Model MoV Maturity Model (aligned with P3M3)

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