Charles Lu Email & Phone Number

Charles Lu Skills

• 21 CFR Part 11
• Aseptic Processing
• Biopharmaceuticals
• CAPA
• Change Control
• Cleaning Validation
• Computer System Validation
• Corrective and Preventive Action (CAPA)
• EMA
• EMA - ICH Guidelines Q7A, Q8, Q9, Q10, Annex 11, ASTM e2500, ITIL Certified
• FDA
• FDA Guidelines 21 CFR part 11, 820, 210, and 211
• GAMP
• GLP
• GMP
• Good Laboratory Practice (GLP)
• GxP
• ICH guidelines
• ISO 13485
• ISO 13485 and 14971
• LIMS
• Quality Assurance
• Quality Control
• Quality System
• Regulatory Submissions
• SOP
• Standard Operating Procedure (SOP)
• Technology Transfer
• Trackwise
• U.S. Food and Drug Administration (FDA)
• U.S. Title 21 CFR Part 11 Regulation
• V&V
• Validation
• ITIL Certified
• Good Laboratory Practice Glp
• Biotechnology
• Astm E2500
• Process Improvement
• Engineering
• Q10
• Corrective And Preventive Action Capa
• Microsoft Office
• Annex 11
• Fda Guidelines 21 Cfr Part 11
• Customer Service
• U.S. Food And Drug Administration Fda
• Project Planning
• Standard Operating Procedure Sop
• Ich Guidelines Q7A
• Architecture
• Quality Systems
• u.s. Food and Drug Administration
• Corrective and Preventive Action
• Standard Operating Procedure
• Good Laboratory Practice