Chea Kunwon's Contact Details

Chea Kunwon's Company Details

QUACOAPIT

Philadelphia, PA, US • 5 - 9 Employees
Major Drugs

Vision: Solving Quality and/or Compliance business problems for organizations in need within the Pharmaceutical and Medical Device Industries.Mission: Hiring qualified professionals to in need to perform those roles. Service(s): (1) Manufacturing operations improvement; (2) Productivity improvement; (3) Quality assurance and Quality control; and (4) Quality AuditsServices is also not limited to: • Batch Record Review• Non-conformance Investigation• Quality Compliance Investigation• Environmental Monitoring• Root Cause Analysis• Implementation• Internal and External Audits• SOP creation and updates• cGMP, Compliance training• Label Q.A. & QC Review• Deviation investigations • Product & Medical Device Complaints Investigation• Corrective & Preventive Actions• Annual Product Review (APR)• Continuous/Process Improvements• MedDevice Complaints: Intake, investigation, and Closures• Metrics• Medical Device Investigation• Medical Device Reporting• PSURs• Quality & Compliance Inspection• Assistance with FDA issued 483s• Assistance with Drug recalls• Assistance with MedDevice Recalls