Sharon Shachar Email

Sharon Shachar Skills

• 21 CFR
• 21 CFR Part 11
• 21 CFR part 210/211
• AS9100
• Analytical Skills
• Asian Culture
• CAPA
• Change Control
• Change Management
• Claims Management
• Combination Products
• Communication
• Corrective and Preventive Action (CAPA)
• Crisis Management
• Cross-functional Team Leadership
• Design Control
• FDA
• FDA GMP
• FDA inspections
• GMP
• IATF 16949
• ISO 13485
• ISO 14971
• ISO 9001
• ISO Standards
• ISO/TS 16949
• Internal Audits
• Leadership
• MDSAP
• Management Systems
• Manufacturing
• Medical Device Regulation (MDR)
• Multi-site Team Management
• People Management
• Pharmaceutical Industry
• Problem Solving
• Process Improvement
• Process Validation
• Quality Assurance
• Quality Auditing
• Quality Control
• Quality Management
• Quality Process Development
• Quality System
• Quality Systems
• Quality by Design
• Quality culture
• Quality managment
• Regulatory Affairs
• Regulatory Compliance
• Regulatory Requirements
• Risk Assessment
• Risk Management
• SOP
• Safety Compliance
• Site Inspections
• Strategic Leadership
• Team Leadership
• U.S. Title 21 CFR Part 11 Regulation
• US FDA
• US FDA QSR 21 CFR 803/820
• V
• Validation
• Verification and Validation (V&V)
• Medical Devices
• ISO
• Continuous Improvement
• Human Resources
• Employee Relations
• Cross Functional Team Leadership
• Corrective and Preventive Action Capa
• u.s. Food and Drug Administration Fda
• Business Process Improvement
• Standard Operating Procedure Sop
• Corrective and Preventive Action
• u.s. Food and Drug Administration
• Standard Operating Procedure