The exposure is usually in the paperwork, not the process.
Thirty-five years of food science, thermal process validation and regulatory strategy. I write about where manufacturers are actually exposed, and why the industry keeps finding out the expensive way.
- Scope
- Process authority under 21 CFR Parts 113, 114 and 117
- Specialty
- Aseptic process validation
- Certification
- Better Process Control School. Preventive Controls Qualified Individual under FSMA. HACCP and Seafood HACCP. Acidified foods school
- Listing
- AFDO Food Processing Authorities Directory. One of approximately 100 process authorities in the directory and one of seven listed with aseptic specialization. Verify the listing
- Record
- 500+ brands formulated across 35 years
- Policy
- Idaho delegate to the Food Northwest Education and Research Institute board, engaging with the Idaho legislature on food related matters
- Facility
- Active aseptic pilot plant in Portland with a Sidel Aseptic Lab Unit, permitted through TTB and the state of Oregon. Capabilities
- Practice
- Founder and CEO, The Helmsman Group. Co-founder, RegulateCPG
Recent writing
Where operators are exposed right now
A weekly analysis of regulatory risk, plaintiff litigation theories and classification ambiguity in food and beverage. Every position is sourced and every conclusion states what would falsify it.
Quoted in
- Forbes
- MarketWatch
- Yahoo
- The Food Institute
- Food Processing
- AllRecipes
- The Daily Meal
- Techstrong.ai
Where to go next
Three doors
Process authority work
Thermal process validation, aseptic filings, scheduled processes and regulatory review.
The Helmsman GroupCompliance software
Label review, claim substantiation and compliance infrastructure for manufacturers and brands.
RegulateCPGThe newsletter
One analysis a week on regulatory exposure and litigation risk. Free, and no pitch attached.