Investigator Details
Amy N Chen
Investigation Details
Last Issued Date:
August 5, 2022
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Amy N Chen thoroughly reviews aseptic processing procedures, facility design, and media fill simulations to ensure the prevention of microbial contamination in sterile products and areas. She may focus on airflow patterns and air quality in different areas of the facility.
Profile:
Amy N Chen is a meticulous investigator with a deep focus on aseptic processing and facility design. She prioritizes the prevention of microbial contamination in sterile products and areas. She has a critical eye for the adequacy of media fills in simulating real production scenarios.
Top Process Types:
- Environmental Monitoring
- Contamination Control
- Facility Design
- Process Validation
- Batch Records
