Product and operation review
Organize the product, process, intended use, establishment activities, and applicable FDA or USDA/FSIS questions for review.
Discuss your needsTechnical expertise
Regulatory & technical support
Connect requirements and technical expectations to your actual products, activities, documents, and operating evidence.
Inspection and response support
Clarify technical findings, assemble records, identify gaps, and connect corrective actions to supporting evidence.
Discuss your needsDocument and team readiness
Review food safety and GMP documentation, responsibilities, and training needs, including food and dietary-supplement operations within the agreed scope.
Discuss your needsDefine the question.
Build the scope around it.
Start with the decision you need to make, the information available, and any relevant deadline. Agree on responsibilities, outside services, and deliverables before work begins.
Start a scope discussionPrepare for the conversation
- Product categories and establishment activities
- The requirement, finding, or question
- Current plans, procedures, and affected records
- Relevant communications and response deadline
Find authoritative resources
Use official FDA and USDA sources as the starting point.
Explore the resourceScience, operations, and regulation
Learn how Ernest’s background connects to the work.
Meet Ernest BlackWork with the Institute
Discuss your needsA food safety question deserves a useful conversation.
Tell us what you make, what you need to decide, and when. Start with an initial scope discussion, followed by a proposal for the work you need.