Services
BUSINESS CAPACITY
Food Protection (Food Defense, L.L.C., Philomont, VA)
• On-Site Food Protection Vulnerability Assessments (Facilities, Personnel, Operations)
• Food Defense Plan Analysis, Design & Operational Integration
• Food Defense Technology Assessments
• Import/Export Product Shipment & Security Programs (e.g. Customs Trade C-TPAT)
• FDA Bioterrorism Registration, Shipment Prior-Notice, FDA Refusals and Detentions and Administrative Assistance
• Product and Packaging Traceability Systems/Programs
• Assistance with FDA Public Health Security and Bioterrorism Preparedness and Response Act of 2002, USDA and FDA Food Defense Guidelines and other government/industry program requirements impacting the food industry
• Food Defense On-Site or Web-based Training
• FDA Food Safety Modernizatization Act (FSMA) Operational, Regulatory & Administrative Assistance
Risk Assessment, Prevention and Response Decision Support
• Risk Assessment, Knowledge and Decision Management
• Simulation Event Development and Testing, Gaming and Complex Decision Support Training
• Crisis and Event Sequence Response Planning and Communication
• Standards and Best Industry Practice Consulting
Partners: Food Safety (Food Defense, L.L.C., EAS Consulting Group, Alexandria, VA, Registrar Corp, Newport News, VA, TechniCAL, Inc., Metairie, LA*
(*TechniCAL Main Office- Metairie. LA and Food Solutions, Lima, Peru)
Partners: General Consulting Services (Food Defense, L.L.C., EAS Consulting Group, Registrar Corp., TechniCAL, Inc., )
• FDA/USDA-FSIS Canned Food Process Authority Services (Third-party Scheduled Process and Critical Factor Establishment, Development, Safety Reviews, Preservation Equipment Testing and Product Process Validation, FDA Registration and Process Filing) for Low-Acid (LACF) and Acidified Foods (AF)
• Automated Process Control Validation for Sterilization and Pasteurization Equipment
• Novel Technology Assessment & Product /Package Application Evaluation
• Regulatory Interpretation, Compliance, Policy and Procedures Assistance
• FDA and USDA 483 Review of Inspectional Findings and Response Assistance
• Hazard Analysis & Critical Control Points (HACCP), Sanitation Standard Operating Procedures (SSOP), Good Manufacturing Practice (GMP)Program Development, Implementation and Verification
• USDA-FSIS HACCP Plans and Programs
• FDA GMP, HACCP & USDA-FSIS HACCP Compliance Audits
• Thermal Processing Operational Assessments and Audits (e.g. Food Processors, Co- Manufacturers and Suppliers)
• Process Establishment Assessments for FDA and USDA-FSIS Compliance
• Process Improvement Assessments (Enabling Capacity, Improve Product Quality, Manage Costs)
• Foreign Processor and Import Product Detention Assistance
• U.S. and Foreign Government Technical Assistance and Training
Partners: Domestic & International Canning Technology Training (Food Defense, L.L.C., TechniCAL, Inc)
• Basic Thermal Processing Course (Process Establishment, Process Deviation Evaluation, Data Collection, Heat Penetration and Temperature Distribution, Thermal Processing Systems, FDA and USDA Regulations
• Advanced Thermal Processing Course (Theory, Advanced Thermal Process Calculations, Complex Process Deviation Evaluations)
• Non-thermal Process Establishment and Equipment Validation
• Thermal Process Equipment Installation, Operation and Regulatory Compliance
• FDA & USDA Regulations (HACCP, GMP Best Practice Compliance, Policy, Procedures and Operational Implementation)
• Process & Automated Process Control System Validation
• U.S. and Foreign FDA Better Process Control School (BPCS) Instruction
• Manufacturing Assessments (e.g. Compliance, Process Improvement, Failure Analysis)
• Thermal Processing of Semi-Rigid and Flexible Packaging Course
• FDA and USDA Inspectional Techniques
• Understanding U.S. Canning Regulations
• How to Properly Manage Regulatory Inspections, Product Recalls, and Regulatory Enforcement Actions
• Custom Food Safety and Thermal Processing Training
New Product Design/Build/Delivery (Food Defense, L.L.C., EAS Consulting Group, Registrar Corp, TechniCAL, Inc.)
• Prototype Design and Critical Review Assessment
• FDA and USDA-FSIS Process Authority Consulting for Regulatory Acceptance or Approval
• Start-up Assistance and Market Delivery
• Factory Acceptance Testing (FAT)