Investigator Details
Wendy G Tan
Investigation Details
Last Issued Date:
November 15, 2023
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Wendy G Tan has a methodical and thorough approach to inspections, focusing on in-depth analysis of deviations, complaints, and CAPA actions. She pays close attention to documentation, contamination control, and equipment qualification, seeking evidence of comprehensive root cause analysis and proactive control measures.
Profile:
Wendy G Tan is a meticulous and detail-oriented FDA auditor who places significant emphasis on root cause analysis, complaint management, CAPA effectiveness, document management, contamination control, change control, and equipment qualification.
Top Process Types:
- Contamination Control
- Preventive Maintenance
- Environmental Monitoring
- Investigations
- Quality Risk Management
