8-hour Quality and Process Improvement Techniques and Tools

Course Description Proper investigation of issues identifying the root cause is critical to the long-term success of a clinical trial. Using the correct quality tools and techniques is essential to ensure the problems are fully understood, investigated, and resolved. This interactive course is designed for quality staff and clinical staff who seek to better understand how to select and utilize various tools to investigate risks and proactively mitigate them. The workshop will include hands-on experience using various quality tools and techniques while discussing case studies in clinical trials. Throughout the course we will: Investigate the root cause of typical clinical trial issues and risks proactively Establish proper mitigation/solutions reflective of acceptable long-term plans that regulatory authorities expect Review and utilize process improvement techniques with various challenges in clinical trials Review how to streamline processes frequently used in clinical trials and discuss typical challenges Upon completion of this course, you will have the knowledge and skills to utilize multiple quality tools and techniques to uncover the root cause of critical risks within your clinical trials and be able to properly document the investigation and resolution of those challenges. In addition, we will review other process improvement techniques and streamlining other documented processes frequently used in clinical trials. Learning Objectives Describe various quality tools and techniques to use for root cause analysis and process improvement in clinical trials Apply various quality tools and techniques and understand when to use them Identify and document issues/risks early on and utilize various tools and techniques to properly investigate them Develop and implement effective process improvement strategies for clinical trials in different situations to demonstrate oversight Course Outline Module 1: Examples of Issues Requiring Quality and Process Improvement Techniques and Tools (Check Sheets and Histograms) Module 2: Cause and Effect Diagram (Ishikawa/Fishbone Diagram); Pareto Chart; Scatter Diagrams Module 3: Flowcharts & Process Mapping Module 4: Suppliers, Inputs, Process, Outputs, And Customers (SIPOC); Process: Define, Measure, Analyze, Improve, Control (DMAIC) Instructor Susan M. Leister, MBA, PhD, CQA, CSSB Click here for complete trainer biographies AccreditationBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.0 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.ACPE#: 0778-0000-26-001-L99-P Released: 5/26. Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.