Live Webinar- "Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs"

Live Webinar: Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs When: Thursday September 30, 2021 - 01:00 PM Duration: 90 Minutes.

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In a pharmaceutical clinical trials environment, just about anyone can find themselves in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for employees. The primary goal of an inspection readiness program is to avoid observations. However (and, despite your best efforts) audits and inspections do result in observations for many companies.

LEARNING OBJECTIVES
At the completion of this session, you will be able to…
Appropriately interpret an observation (the first step to developing an appropriate response)
Identify the key expected elements of a great CAPA
Write a CAPA that is both grammatically correct and specifically addresses the observation
Use SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals to craft your CAPA