Inspection Readiness Training
INSPECTION READINESS TRAINING OVERVIEW:
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.
Inspection Readiness Course participants will gain a thorough understanding of the following:
- 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
- FDA Audit terminology
- Effective personnel management during the inspection
- Tour route development
- Organized approach to inspections
- Prepared personnel
- Inspection success
The course is conducted by PathWise facilitators or by certified client instructors. Our facilitators have extensive backgrounds in third party inspection readiness and quality system management.
Inspection Readiness 2 day training is worth 1.5 credits.
PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.
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We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system, which is why 90% of our courses are taught on-site at our client’s locations. For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.
View the PathWise Events page to find out about our options for a public workshop.