CAPA is the most cross-functional of all subsystems of your QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advance knowledge and awareness of what to expect during the FDA inspection will drastically assist your firm in the ability to anticipate the inspector’s questions, and how to “translate” your CAPA system into what the inspector is looking for.

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as straightforward proven recommendations how your company can use that same document in your preparation.