Luis Lu

Background

About Luis Lu

Technical - Analytical Chemistry, Analytical Method Development, Aseptic Processing, Batch Record Review, Biopharmaceutical Study Design, Drug Chemistry, CMC Review, Commissioning, Corrective and Preventive Action (CAPA), Design Controls, Document Controls, Software Engineering, Process Engineering, Factory Acceptance Testing (FAT), Failure Investigations, Fermentation, Laboratory Information Management Systems (LIMS), Lasers, Lyophilization, Out-of-Specification (OOS) Investigations, Process Optimization, Program Management, Project Management, Quality Engineering, Risk Analysis, FMEA Risk Analysis, Root Cause Analysis, SAP, Stability Programs, Statistical Process Control (SPC), SOP Development, Aseptic Sterilization. Validation – Analytical Method Validation, Cleaning Validation, Computer Control System Validation, Equipment Validation, Facility Validation, Process Validation, Retrospective Validation, Prospective Validation, Software Validation, Validation Project Plan, Validation Master Plans, SAP and MES.