Harold Elder Email & Phone Number

Harold Elder Skills

• ISO Standards
• Contingency Planning
• Compliance Auditing
• Pharmaceutical Industry
• Validation
• FDA
• Sop
• 21 CFR Part 11
• Change Control
• Medical Devices
• CAPA
• Quality System
• Regulatory Affairs
• Quality Assurance
• GAMP
• Regulatory Submissions
• Trackwise
• Cleaning Validation
• GxP
• GLP
• GMP
• Aseptic Processing
• Technology Transfer
• LIMS
• Regulatory Requirements
• Corrective and Preventive Action (CAPA)
• Laboratory Information Management System (LIMS)
• Standard Operating Procedure (SOP)
• Good Laboratory Practice (GLP)
• U.S. Title 21 CFR Part 11 Regulation
• Cross-functional Team Leadership
• Management
• Verification and Validation (V&V)
• Quality Auditing
• Continuous Improvement
• Manufacturing
• Quality Management
• U.S. Food and Drug Administration (FDA)
• Process Improvement
• Verification and Validation V&V
• Laboratory Information Management System Lims
• Training
• Cross Functional Team Leadership
• Standard Operating Procedure Sop
• Good Laboratory Practice Glp
• Operations Management
• Marketing
• Corrective and Preventive Action Capa
• Corrective and Preventive Action
• Laboratory Information Management System
• Standard Operating Procedure
• Good Laboratory Practice
• u.s. Food and Drug Administration
• Verification and Validation