Jeff Moulic Email & Phone Number

Jeff Moulic Skills

• 21 CFR Part 11 Compliance
• CAPA & Root Cause Investigation
• Cell & Gene Therapy Manufacturing Support
• Change Control & Deviation Management
• Cleaning Validation
• Commissioning, Qualification & Validation (CQV)
• Cross-Functional Team Leadership
• FDA Consent Decree Remediation
• Facility Start-Up & Capital Projects
• GMP Compliance (FDA & EU GMP)
• Kneat & ValGenesis Electronic Validation Systems
• Life Sciences Consulting (Biotech, Pharmaceutical & CDMO)
• Process Validation & Continued Process Verification
• Project & Program Management
• QC Laboratory & Analytical Instrument Qualification
• Quality Assurance Validation (QAV)
• Regulatory Inspection Readiness
• Regulatory Remediation Programs
• Risk Assessments & Validation Strategy
• Serialization & Packaging Validation
• Tech Transfer & GMP Readiness
• Utilities & Process Equipment Qualification
• Validation Lifecycle Management
• Vendor & Consultant Management
• GxP
• Computer System Validation
• 21 CFR Part 11
• CAPA