Course description
Inspection Readiness
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.
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Upcoming start dates
Training content
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
Why choose PathWise?
Founded in 1998
4000+ classroom learners every year
Over 10,000 users of online courses
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PathWise
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...