Clinical Quality Oversight has ended
Back To Schedule
Monday, September 27 • 1:00pm - 4:30pm
WORKSHOP C: Clinical CAPA Flavors, Which is for You?

Log in to save this to your schedule, view media, leave feedback and see who's attending!

Explore the Different Levels of Clinical Corrective and Preventive Actions (CAPAs)  
In this workshop you will learn about the different levels of CAPAs and how to apply a methodology which is right for the level of CAPA sought.
  • Explore the base of all the flavors? --- It's vanilla! (The basic problem to be solved: a regulatory compliance issue.) 
  • Determine when different flavors make sense?--- Rocky Road may mean lots of moving parts to the root cause, correction, preventative action; whereas, Coffee may mean 1 moving part and a simple resolution: formal letter asking for action.
  • How to mix the batch to get the right flavor. Escalation of approaches.
  • Determine when just the base flavor will suffice.

avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →

Monday September 27, 2021 1:00pm - 4:30pm EDT