Understand: The purpose and types of FDA inspections
The Regulatory Requirements and Guidelines relevant to inspections
FDA Inspection boundaries for: pictures, sample collection, quality system review
The proper way to interact with an FDA investigator
FDA Audit terminology
Effective personnel management during the inspection: Contact Team, “Go For” Team, Tour Leads
Developing tour routes
Identify and organizing conference rooms for audit interviews
In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help...
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