Investigator Details
Lori M Newman
Investigation Details
Last Issued Date:
April 4, 2024
Conversion Rate:
25
No. of 483’s Issued :
4
Warning Letters Issued:
1
Detailed Analysis
Approach:
Lori M Newman adopts a methodical approach during inspections, prioritizing meticulous review of aseptic processing areas, sterilization processes, and equipment calibration. She focuses on identifying deficiencies and ensuring strict adherence to regulatory standards.
Profile:
Lori M Newman is a meticulous and detail-oriented FDA auditor with a strong focus on aseptic processing, sterilization, equipment calibration, and regulatory compliance. She prioritizes the establishment and adherence to procedures that prevent microbiological contamination and ensure aseptic conditions. Additionally, she has a keen eye for construction issues that may hinder proper operations in a manufacturing facility.
Top Process Types:
- Contamination Control
- Environmental Monitoring
- Document Management
- Cleaning Validation
- Facility Design