Topics
- CAPA Implications of Investigations Operations Manual (IOM), and Recommended Methods of Compliance for each Requirement
- Documents Used by FDA Inspectors
- QSIT Manual: Description of each CAPA Inspectional Objective, and Recommended Methods of Compliance
- CAPA Implications of CPG Manual 7382.845, and Recommended Methods of Compliance for each Requirement
Who should Attend
Attendees from Diagnostic, Medical Device, Biologics and Pharmaceutical fields, including Regulatory Management, Executive/Senior Management, Any personnel who may have direct interaction with FDA officials, QA Management, Quality System Auditors and Consultants.
