FSVP Compliance Training and Implementation Support
Build internal knowledge. Execute FSVP with confidence.
Whether you are a U.S. importer or a foreign supplier supporting your buyer’s verification obligations, this training support service equips your team with the regulatory understanding, process knowledge, and technical insight required under FDA’s Foreign Supplier Verification Program (FSVP) requirements.
This service includes guided training sessions, document walkthroughs, and tailored materials to help your staff understand their role in maintaining a compliant FSVP system — whether through live remote delivery, slide presentation, or direct coaching.
Scope of Work
A. When Training is Delivered to U.S. Importers
1. Pre-Training Planning and Customization
- • Determine the trainee’s role (importer, FSVP QI, QA support, etc.)
- • Review the company’s product scope and applicable FSVP exemptions
- • Customize the training program to align with the importer’s supply chain and current documentation system
2. Regulatory Orientation
- • Provide overview of FDA’s FSVP framework under 21 CFR Part 1, Subpart L (§1.500–§1.514)
- • Explain the importer’s legal responsibility for each foreign supplier and product category
- • Discuss enforcement triggers, inspection scope, and warning letter trends
3. Training Delivery (Live or Document-Based)
- • Present or provide the training session in chosen format (e.g., webinar, recorded slide deck, PDF guide)
- • Walk through each component of a compliant FSVP program (hazard analysis, supplier evaluation, verification, and records)
- • Explain how to apply internal SOPs to support traceability and documentation
4. Document Walkthrough and Implementation Support
- • Guide staff through use of templates (e.g., supplier review form, hazard analysis log, verification checklists)
- • Explain document flow, timing, and the role of qualified individuals in verification
- • Provide technical clarifications where needed (e.g., decision trees for supplier approval)
5. Post-Training Engagement and Final Package
- • Provide comprehension quizzes or live Q&A if training is done interactively
- • Deliver training summary in requested format (PDF, slides, or printable SOP support aid)
- • Issue certificate of participation (if live session is conducted)
B. When Training is Delivered to Foreign Suppliers
1. Pre-Training Planning and Customization
- • Identify if the foreign supplier is supporting a single U.S. buyer or multiple
- • Determine the product type and whether preventive controls or HACCP applies
- • Customize training focus based on buyer’s verification requests (e.g., audit reports, COAs)
2. Regulatory Orientation for Supplier Context
- • Explain what FSVP is and why buyers request documentation
- • Clarify the foreign supplier’s role (supporting compliance vs. being legally responsible)
- • Present 21 CFR 1.500–1.514 in simplified context for foreign export teams
3. Training Delivery (Live or Document-Based)
- • Present or distribute training in English or translated format (upon request)
- • Explain how to prepare and send hazard analyses, food safety plans, and test reports in a format acceptable to U.S. importers
- • Provide examples of acceptable third-party audit certifications and test COAs
4. Supplier Document Coaching
- • Coach team on document presentation, submission timelines, and labeling
- • Walk through document gaps or unclear entries typically flagged by U.S. importers
- • Explain expectations for annual updates and supplier re-verification
5. Post-Training Package
- • Deliver reference slides, handouts, and practical checklists
- • Offer internal job aid templates (e.g., document cover sheet, self-inspection checklist)
- • Provide optional email support for 1 round of clarification after delivery
Sample Training Itinerary (for direct, live delivery only)
| Day/Stage | Activity |
|---|---|
| 1–5 | Training material preparation and review |
| 6–8 | Live session (1–2 hours) or delivery of training slides/presentation, with Q&A or document walkthrough with trainee/s |
| 9–10 | Final delivery of materials + post-training summary |
Note: Actual training schedule depends on the complexity of the facility and the applicable requirements, and is subject to change.
Regulatory Sections Covered
This training service supports interpretation and application of the following sections under 21 CFR Part 1, Subpart L (§1.500 – §1.514), including:
- • §1.502 – What is an FSVP
- • §1.504 – Hazard Analysis
- • §1.505 – Evaluation of Food and Foreign Supplier
- • §1.506 – Supplier Verification Activities
- • §1.507 – Corrective Actions
- • §1.508 – Reassessment
- • §1.509 – Importer Identification
- • §1.510 – Records
- • §1.512 – Modified Requirements
Deliverables
- • Customized training materials (PDF, slide deck, or live presentation)
- • Training certificate (if session is interactive or direct)
- • Document walkthrough session (live or recorded)
- • Reference guides or job aids based on your needs
- • Optional email support for clarification after training
Pricing and Timeline
| Package | Total Service Hours | One-time Investment | Recommended for |
|---|---|---|---|
| Growth | 60 hrs | $720.00 | Multiple suppliers, growing compliance demands |
| Advanced | 80 hrs | $960.00 | Prepping for FDA FSVP inspection or new supplier rollout |
| Success | 100 hrs | $1,200.00 | Continuous support across multiple entries |
| Mastery | 150 hrs | $1,800.00 | Full-service importer program management |
Standard DoBuilt-In Flexibility: Credit Rollover System cumentation Package – $1,750.00 (One-Time Fee)
Unused training hours do not expire and may be redeemed for advanced deliverables, including:
- • FSVP SOP customization support
- • Retraining sessions
- • Supplier documentation reviews
- • Label reviews Example: Apply 3 unused hours = $36 value toward other FSVP compliance services
Why This Works
- 1. Supports scalable importer education as staff or supplier relationships grow
- 2. Reinforces accountability and knowledge retention
- 3. Smoothly transitions learning into documented program implementation
Empower your team with the knowledge to comply.
Train your staff today to protect your brand and prevent costly violations.