Why Should You Attend:
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 how your company can use that same document in your preparation.
Areas Covered in the Webinar:
Documents Used by FDA Inspectors
Operations Manual (IOM)
CAPA Implications, by Section
Requirements
Recommended Methods of Compliance for Each Requirement
CPG Manual 7382.845
CAPA Implications, by Section
Requirements
Recommended Methods of Compliance for Each Requirement
QSIT Manual
Description of each CAPA Inspectional Objectives
Description/explanation
Recommended Methods of Compliance
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 how your company can use that same document in your preparation.
Areas Covered in the Webinar:
Documents Used by FDA Inspectors
Operations Manual (IOM)
CAPA Implications, by Section
Requirements
Recommended Methods of Compliance for Each Requirement
CPG Manual 7382.845
CAPA Implications, by Section
Requirements
Recommended Methods of Compliance for Each Requirement
QSIT Manual
Description of each CAPA Inspectional Objectives
Description/explanation
Recommended Methods of Compliance
