Investigator Details
Yoriann M Cabrera Bartolomei
Investigation Details
Last Issued Date
December 22, 2023
No. of 483’s Issued
since 2023
2
Warning Letters Issued
0
Detailed Analysis
Approach:
Yoriann M Cabrera Bartolomei meticulously scrutinizes the quality control processes, facility construction, computer systems, equipment qualification, and environmental monitoring. They prioritize thorough documentation, validation, and investigation into various critical aspects of drug manufacturing and processing.
Profile:
Yoriann M Cabrera Bartolomei focuses on the quality control unit, aseptic processing areas, building construction, computer and IT systems, equipment qualification, environmental monitoring, reserve sample investigation, laboratory controls, and material handling procedures.
Top Process Types:
- Environmental Monitoring
- Investigations
- Document Management
- Data Integrity
- Contamination Control
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