Investigator Details
Erik W Koester
Investigation Details
Last Issued Date:
September 30, 2022
Conversion Rate:
0
No. of 483’s Issued :
9
Warning Letters Issued:
0
Detailed Analysis
Approach:
Erik W Koester adopts a meticulous approach, focusing on the physical state of the facility, cleanliness of equipment, and adherence to validation and calibration processes. Written procedures for production and process controls are also of high importance to him.
Profile:
Erik W Koester is a detail-oriented auditor with a strong focus on facility maintenance, equipment cleanliness, validation processes, and calibration. He is likely to prioritize adherence to written procedures for production and process controls, as well as aseptic processes.
Top Process Types:
- Cleaning Validation
- Contamination Control
- Equipment Cleaning
- Environmental Monitoring
- Batch Records