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PCQI On Demand

Expert FDA Compliance Support When You Need It

Your All-Access Pass to Stress-Free FSMA Compliance
Overwhelmed by FDA inspections, supplier approvals, and compliance gaps?

The Fast Track to Bulletproof Preventive Controls
Struggling to keep up with hazard analyses, supply chain programs, and FSMA requirements on your own?

Your Backstage Pass to FDA-Ready Food Safety
Tired of uncertainty about whether your suppliers and processes meet FDA standards?

The PCQI On Demand Membership provides on-demand access to a Preventive Controls expert, compliance tools, and audit support—so you can ensure food safety with confidence, without the cost of a full-time consultant.

On-Demand PCQI & FSMA Compliance Support

  • Instant access to FDA compliance experts for navigating Preventive Controls, supply chain programs, and FSMA regulations. For food manufacturers, processors, and facilities who need:
    • ✅ Urgent PCQI guidance when production or audits are at risk
    • ✅ Supply chain verification support to avoid FDA 483s or Warning Letters
    • ✅ Inspection prep to breeze through FDA audits with confidence
    • ✅ Hazard analysis reviews to ensure compliance with FSMA rules
    • ✅ Corrective action support for deviations or non-conformances
    This flexible, 4-hour/month service gives you:
    • ✅ Direct access to a Preventive Controls Qualified Individual (PCQI)—No more guessing about FSMA requirements
    • ✅ Crisis resolution for FDA findings, non-compliance issues, or audit failures
    • ✅ Documentation reviews for your Food Safety Plan before submissions
    All without the cost of a full-time consultant.

PCQI Compliance Shield: Audit-Ready Food Safety Review

  • Ensure full compliance with FDA FSMA Preventive Controls (21 CFR 117) through expert review of your:
    • ✅ Hazard Analysis & Risk-Based Preventive Controls
    • ✅ Supply-Chain Program & Supplier Verification Records
    • ✅ Food Safety Plan Documentation & Validation Records
    • ✅ Monitoring, Corrective Actions, and Verification Procedures
    Why This Matters for PCQIs:
    • ✅ Prevent FDA 483s & Warning Letters with a gap-free Food Safety Plan
    • ✅ Simplify audit prep with organized, compliant documentation
    • ✅ Confidently meet FSMA requirements without last-minute fixes
    Expert-reviewed. Audit-ready. Compliance assured.

PCQI Guardian Exclusive Perks: Compliance Resource Savings

  • Members save on the tools that keep your food safety program audit-ready:
    • ✅ Custom Food Safety Plan (FSP)/HACCP Assessments
      • FDA-compliant Preventive Controls templates tailored to your facility – 50% off non-member rates
      ✅ Supplier & Co-Manufacturer Audit Kits
      • Pre-built GMP, hazard analysis, and verification checklists – **Only $99**(regularly $250)
      ✅ FSMA Compliance Management Software
      • Streamline HARPC documentation & monitoring records – Free onboarding + 15% off first year
    Why Pay Full Price?
    • These member discounts can save you $1,000+ annually – nearly offsetting your entire membership cost!

Rollover Compliance Credits – Maximize Your PCQI On-Demand Membership

  • Your unused monthly support time carries over—so nothing goes to waste! With PCQI On Demand Membership, unused hours convert into credits for:
    • ✅ Full Facility Gap Assessments (FDA-ready audits)
    • ✅ Emergency FDA Inspection Support (483/Warning Letter response)
    • ✅ Food Safety Plan & HARPC Reviews (Preventive Controls validation)

How It Works:

  • ✅ Bank unused hours each month as redeemable credits
  • ✅ Save them for intensive compliance projects or audits
  • ✅ Redeem later for premium services at 20% off standard rates
  • *Example: Save 3 monthly credits = $297 toward a full GMP facility audit.*

Why It Matters for PCQIs:

  • • No "use it or lose it" stress – Adapt to production cycles
  • • Handle seasonal demands (e.g., SQF/FDA audit prep)
  • • Unlock high-value services at member-exclusive discounts

Why This Works for PCQIs:

  • 1. Turns FSMA compliance into a predictable, budget-friendly process – No more surprise consulting fees or last-minute scrambles.
  • 2.Crisis support tackles your worst nightmare – FDA 483s, Warning Letters, or failed audits don’t have to derail production.
  • 3. More than just checklists – Builds real food safety expertise across your team, reducing reliance on external consultants long-term.

Key PCQI Benefits:

  • ✔ Cost Control – Fixed monthly cost beats unpredictable consulting bills.
  • ✔ Risk Mitigation – Instant help when FDA shows up or hazards slip through.
  • ✔ Knowledge Growth – Training and SOPs that strengthen your in-house capabilities.
  • Because compliance isn’t just paperwork—it’s protecting your brand, products, and customers.

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.