Investigator Details
Richard Ledwidge
Investigation Details
Last Issued Date:
August 30, 2022
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Richard Ledwidge utilizes a meticulous approach, prioritizing thorough examination of GMP manufacturing processes, laboratory operations, and the prevention of microbiological contamination. He focuses on validation of cleaning procedures, suitability of water for manufacturing processes, and proper documentation of batch records.
Profile:
Richard Ledwidge is a detail-oriented FDA auditor who focuses heavily on GMP manufacturing, laboratory operations, and microbiological contamination prevention. He places great emphasis on validation of cleaning procedures, water suitability for manufacturing processes, and batch record documentation.
Top Process Types:
- Batch Records
- CAPA
- Cleaning Validation
- Contamination Control
- Aseptic Process Simulation Studies
