Process Management Framework: Best Practices for Implementation of Processes in Clinical Development


QMS Process Management Framework Webinar Recording: 


Clearly defined, documented, and managed processes form the foundation for how we effectively develop medicines for our patients. For this reason, process has been identified as a primary “element” of an effective quality management system (QMS) as described in the TransCelerate clinical quality management system (CQMS) conceptual framework. The importance of identifying and effectively managing critical processes is also emphasized in ICH GCP E6 (R2) in the new Section 5.0 Quality Management. An effective process management framework is fundamental to ensure the efficient and effective delivery of clinical development programs, enhance quality and productivity, and ultimately benefit our ability to deliver needed treatments to patients. 

Two free webinar sessions will be held (identical content will be covered at each session):

  • Tuesday 8October 10:00am - 11:30am Eastern time (click here to register) 
  • Tuesday 8October 8:00pm - 9:30pm Eastern time (register below)

Learning Objectives:

  • Understand the conceptual process management framework
  • Apply the conceptual process management framework as guidance for effective process mapping, process documentation, implementation of optimal learning methods, and ongoing process performance evaluation
  • Learn to use the process management framework tools

Target Audience:

This webinar is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring

TransCelerate Clinical QMS Webinar Series -- this webinar topic is one of two that will educate and inform interested audience members about the TransCelerate Clinical Quality Management System (CQMS) conceptual framework, as well as the Risk Management and the Processes Frameworks published by TransCelerate. 

Visit our web page and publications to learn more:

October 8th 2019 from 08:00 PM to 09:30 PM GMT 6