Investigator Details
Heidi L Smith
Investigation Details
Last Issued Date
January 26, 2024
No. of 483’s Issued
since 2023
1
Warning Letters Issued
0
Detailed Analysis
Approach:
Heidi L Smith is thorough and detail-oriented, with a focus on ensuring root cause analysis, compliance, and data integrity. She expects systematic processes and proactive measures to address and prevent compliance issues.
Profile:
Heidi L Smith has a strong focus on corrective and preventive actions, calibration management, batch manufacturing, and data integrity management. She prioritizes thorough investigations into failures, non-conformances, and deviations to target root causes and ensure product quality and data integrity. She values accuracy, reliability, and compliance with GMP requirements.
Top Process Types:
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