James R Birkenstamm
Investigation Details
Detailed Analysis
James R Birkenstamm takes a systematic approach, thoroughly reviewing documentation and validation processes. He pays close attention to the construction and operation of facilities, especially in aseptic areas, and closely scrutinizes computer systems, equipment qualification, environmental monitoring, and laboratory controls.
James R Birkenstamm is an FDA auditor who has a strong focus on quality control, aseptic processing, facility construction, computer systems, equipment validation, environmental monitoring, laboratory controls, and material handling procedures. He is attentive to deficiencies in documentation and validation processes.
- Investigations
- Document Management
- Data Integrity
- Batch Records
- Cleaning Validation
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies