Inspection Aftermath: Digging yourself out of CAPA hell

Inspections can feel like a brutal type of hell… long hours of prep, countless meetings, laundry lists of requests and the constant worry of “are we ready? … inspection ready??” And then the inspection is over and a celebratory collective sigh of relief is felt across the team like a warm sun on your face (aaahhhhh… you all just felt it).  Sadly, that sunshine is only felt for a brief few moments when the post-inspection clouds roll-in with a different type of hell at your doorstep.  Now you must provide responses to findings, identify how and whom are to complete the CAPA’s and then follow-through until completion.   This process can feel just as challenging as preparing for the inspection itself as there are immediate and long term deadlines, multiple stakeholders involved and also ensuring CAPA’s are being completed accordingly and timely.    

In this this session you will learn to manage your CAPA hell by:

• Learning the basics: What is an inspection report? What are the difference between minor, major and critical findings? What are the regulators expecting for responses?
• Defining Root Cause, Corrective Action and Preventative Action
• Writing effective responses that not only satisfy the regulators, but also evolve and improve your processes
• Using tools to manage your CAPA’s through completion….finding the rainbow

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