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Monday, September 27 • 1:00pm - 4:30pm
WORKSHOP C: Clinical CAPA Flavors, Which is for You?

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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.

Speakers
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