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
The PathWise Inspection Readiness Training course takes the participant step-by-step through the entire inspection process. The training describes various types of inspections. Participants will leave with an understanding of the full inspection process, their role, and others roles in that process, and specific steps for preparing and managing the audit.
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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