Richard Nardini Email & Phone Number

Richard Nardini Skills

• Statistical Process Control (SPC)
• Statistical Data Analysis
• QSR
• MDSAP
• Quality Management
• Corrective and Preventive Action (CAPA)
• ISO 14971
• EU MDR 2017/745 Auditor
• European Law
• Internal Auditing to the Medical Device Single Audit Program Including ISO 13485:2016 and Device Regulations from MDSAP Jurisdictions
• ISO 13485:2016 Internal Auditor (TPECS)
• Indysoft Calibration Software Administrator and Process Manager
• Calibration and Process Measurement Uncertainty Analysis and Estimation
• Continuous Monitoring Systems Validation and Process Management
• Sterilization Process Validation (Saturated Steam, EtO, Dry Heat, Depyrogenation, H2O2, etc.)
• Water Systems Validation
• Cleanroom Certification and Validation
• Microbiology and Engineering of Sterilization Processes
• Six Sigma/Lean/Process Management Black Belt Certified
• Quality System
• Quality Assurance
• Validation
• GMP
• Management
• FDA
• Medical Devices