Investigator Details
Esther C Broner
Investigation Details
Last Issued Date:
May 12, 2023
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Esther C Broner adopts a meticulous approach, paying close attention to the details of manufacturing processes, aseptic techniques, and equipment maintenance. She emphasizes the documentation of non-conformance and interventions, while also focusing on the integrity testing of sterilized equipment and facility cleanliness.
Profile:
Esther C Broner is a detail-oriented FDA auditor who focuses on manufacturing process control, aseptic techniques, equipment integrity testing, batch release considerations, clean hold time limits, visual inspection procedures, documentation of non-conformance, equipment revalidation, and facility and equipment maintenance.
Top Process Types:
- Area Cleaning
- Aseptic Technique
- Cleaning Validation
- Equipment Qualification
- Facility Design
