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Articles Tagged "capa"

CAPA Notes from an FDA Inspection

by BONEZONE | Oct 2017

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.... Read more »

When Do I See a CAPA Specialist?

by BONEZONE | May 2017

If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we differentiate between complaints, non-conformances and CAPAs? Our experts respond.... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CAPA+2, UDI and More: What to Expect from FDA in 2015

by Hannah Corcoran | Feb 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Why Won’t My CAPA Process Work?

by John Gagliardi | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Planning for the Unpredictability of Change

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

by BONEZONE | Mar 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Design Transfer, Changes and the Design History File

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Design Review

by BONEZONE | Jun 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Nine Naive Notions About S&OP

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »