Detailed review of all relevant documents and production data.In-depth discussions with key personnel to assess their knowledge and competencies.Hands-on examination of manufacturing facilities, equipment, and operations.

Rita K. Vick is an experienced FDA investigator with a sharp focus on pharmaceutical manufacturing oversight. She specializes in scrutinizing aspects such as data integrity, process validation, and quality control and assurance. Rita frequently identifies common issues such as inadequate record-keeping, data integrity problems, and non-compliance with production processes during her inspections. Her approach to inspections is methodical and thorough, involving detailed document reviews, interactive evaluations with staff to assess their understanding of CGMP, and physical inspections of manufacturing facilities and operations. She emphasizes the importance of comprehensive documentation, regular mock inspections, and continuous staff training to maintain compliance. Rita's detailed knowledge in areas like aseptic processing, contamination control, and quality risk management makes her a formidable presence aimed at ensuring compliance with FDA regulations and improving drug manufacturing standards. Companies prepare for her inspections by enhancing facility layouts, ensuring environmental monitoring systems are functional, and keeping all equipment well-maintained and calibrated.