Live Web Seminars for Clinical Research Professionals

Clinical Process Mapping for Medical Device Trials: Mapping and Optimizing Inspection Ready Workflows

Course Description

This live, instructor-led training provides participants with a practical framework for mapping, visualizing, and optimizing clinical processes specific to medical device trials. Through a structured, step-by-step approach, attendees learn how to transform complex operational pathways into clear, inspection-ready workflows that support quality, data integrity, and regulatory expectations. The course introduces foundational mapping techniques, then applies them directly to IDE and early-stage device study activities, including start-up, conduct, safety, data flow, and oversight functions. Participants will also learn how effective process maps serve as the backbone for SOPs, work instructions, templates, and broader quality system development. By the end of the program, learners will be equipped with actionable tools and templates to strengthen their internal processes and better prepare their organizations for audits and FDA inspections.

Learning Objectives

  • Explain the purpose and value of clinical process mapping
  • Apply foundational process-mapping techniques
  • Map end-to-end clinical workflows
  • Translate process maps into practical SOPs, work instructions, and templates
  • Assess the inspection-readiness of clinical processes
  • Develop a complete, inspection-ready clinical process map

Who Should Attend

  • Clinical Trial Managers
  • Clinical Project and Program Managers
  • Clinical Quality Assurance
  • Regulatory Affairs Staff
  • Clinical Research Associates (CRAs) and Monitors who need a clearer understanding of end-to-end clinical process dependencies and inspection-critical controls
  • Medical Device Startup Leaders and SMEs

Instructor

Shana Zink, B.S., C.C.R.A.

Click here for complete trainer biographies

Accreditation

Barnett 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.