Chris Ernst Email & Phone Number

Chris Ernst Skills

• GMP Regulations (US FDA, EU Directive)
• GCP Regulations (US FDA, ICH GCP, EU Directive)
• GLP Regulations (US FDA, OECD)
• Regulatory Training
• Microbiological Risk Assessment
• Medical Device Regulations (ISO, US FDA, EU Directive)
• Regulatory Inspection- Agency Interaction (US FDA, EMA, MHRA, Health Canada)
• CAP/CLIA Regulations GCLP's
• SOP development
• Quality Managment System Implementation
• CAPA/Field Correction
• Investigative Site Audits
• Vendor Qualification
• Internal-System Audits
• For Cause Investigations - Root Cause Analysis
• Project Management
• Pharmaceutical Industry
• Medical Device Regulations Iso
• Continuous Improvement
• Oecd
• Quality Assurance
• Us Fda
• Gcp Regulations Us Fda
• Regulatory Inspection Agency Interaction Us Fda
• Eu Directive
• Internal System Audits
• Root Cause Analysis
• Ich Gcp
• Glp Regulations Us Fda
• EMA
• Marketing
• Gmp Regulations Us Fda
• Microsoft Excel
• For Cause Investigations
• Health Canada
• MHRA
• Gmp Regulations
• Gcp Regulations
• Glp Regulations
• Medical Device Regulations
• Regulatory Inspection Agency Interaction