Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST Save Your Seat
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100-point Post FDA Inspection

Ensure post-FDA inspection audit readiness with our 100-point checklist. Close inspection gaps, strengthen RCA & CAPA systems, reinforce data integrity, and align with FDA & EMA compliance standards.

100-point Post FDA Inspection
Written By
Vivek Gera
Reading Time
1
Minutes

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100-point Post FDA Inspection

Ensure post-FDA inspection audit readiness with our 100-point checklist. Close inspection gaps, strengthen RCA & CAPA systems, reinforce data integrity, and align with FDA & EMA compliance standards.

100-point Post FDA Inspection
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Dive Deep into the Following Critical Aspects

Documentation

Ensure all records are complete, accurate, and easily accessible.

Process and System Review

Evaluate the efficiency and effectiveness of your processes and systems.

Regulatory Compliance

Verify adherence to all relevant regulations and standards.

Facility and Personnel

Assess the condition of your facilities and the competence of your staff.

Communication & Coordination

Check the effectiveness of internal and external communication channels.

Follow-up and Monitoring

Ensure ongoing tracking and resolution of CAPAs to maintain compliance.

Related Resources
Stay Audit-Ready with FDA Tracker
Join top pharma teams using FDA Tracker to monitor Form 483 trends, track investigators, and prevent repeat observations. Stay compliant and confident—all from one powerful platform.