BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T135129Z UID:ff0d1a44-6cdd-4664-865b-46dbeb6a3e36 DTSTART:20210312T120000 DTEND:20210313T120000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nDuring an inspection\, F DA 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 do cuments 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 sessio n 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 w ell as how your company can use that same document in your preparation.
\n\n \;
\n\nThis session will discuss all the docume nts used by FDA to train their inspectors to review your CAPA system\, som e of which you may not be familiar with. Also contained in this session wi ll be a section-by-section summary of the CAPA subsection of the QSIT\, th e document by which FDA inspectors operate during an inspection\, as well as how your company can use that same document in your preparation.
\n\ nSession Highlights
\n\nDocuments Used by FDA Inspectors
\nOperations Manual (IOM)
\nCAPA Implications\, by Section
\nRecommended Methods of Compliance f or Each Requirement
\nCPG Manual 7382.845
\nCAPA Implications\, by Section
\nRequi rements
\nRecommended Methods of Compliance for Each Requirement
\nQSIT Manual
\nD escription of each CAPA Inspectional Objectives
\nDe scription/explanation
\nRecommended Methods of Compl iance
\n\n \;
\nWho can
Benefit
\nThe employees who will benefit include:
R&\;D Management
\nRegulatory mana gement
\nQA management
\nConsu ltants
\nQuality system auditors
\n