Webinars >>Clinical Trials
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance

A flowchart is invaluable for training personnel and is known to reduce negative audit findings related to compliance to SOPs by about three folds. However, when poorly created flowcharts can also lead to confusion. An organization could have 100s of SOPs with each individual expected to comply with about 10-20 SOPs. More importantly, personnel are seldom trained on the cross-functional relationships between processes that are critical to perform a group of tasks in sync. With a majority of the processes it is nearly impossible to see the holistic process view. SOPs with flowcharts make it easier to remember the various tasks one is assigned to and to understand the relationship between different processes. Hence, organizations should invest in creating good quality flowcharts for their SOPs. Further creating multi-tier SOP flowcharts and cross-functional flowcharts could enhance the quality management system (QMS) and quality manuals (QM).  This webinar will present best practices to build individual SOP flow charts and interconnected process flows. Rules for process mapping will be discussed using case studies.
Why should you attend:
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If your organization uses more than 10 SOPs and includes more than five individuals, you probably struggle with keeping track of all functions, individual performance tracking, troubleshooting delays and non-compliance challenges. This webinar will present ways to increase the efficiency of your systems from within by creating better process maps cross-linking all tasks within your organization. If you want to improve the efficiency of your quality systems, this webinar is for you. If you want to optimize your SOPs and evaluate efficiency tools you should attend this webinar. Case studies and automation tools will be presented.
Areas Covered in the Session:
  • FDA expectations from SOPs
  • Rules for creating flow charts
  • Organizing and aligning SOPs
  • Best practices for creating cross-functional process maps connecting SOPs
  • Identifying and documenting SOP specific triggers, activities, tasks, subtasks, interconnections, approval, metadata, documentation, responsible departments/offices, responsible roles/personnel, laws, regulations, and handoffs
  • Best practices for creating and using flow-charts
  • SOP optimization tools
Who will benefit:
  • QA/QC/compliance/regulatory professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Manufacturing managers, supervisors and personnel
  • Clinical and preclinical laboratory managers
  • Clinical trial specialists
  • Project managers
  • People investing in FDA-regulated product development projects
Date: June 28, 2021
​Duration: ​60 Minutes
​Time: 1 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com