At InterlinkIQ, we offer specialized services to help your company prepare for a successful Foreign Supplier Verification Program (FSVP) FDA audit. Our comprehensive support ensures that you meet all regulatory requirements and navigate the audit process with confidence. Here’s how we can assist you:
Initial Consultation and Assessment
FSVP Readiness Review
Evaluate your current FSVP compliance status and identify gaps.
Regulatory Requirements Analysis
Review FDA requirements for FSVP to ensure you meet all necessary standards.
Supplier Evaluation
Assess the adequacy of your foreign suppliers’ compliance with FDA regulations.
FSVP Plan Development
FSVP Plan Creation
Develop a tailored FSVP plan that meets FDA requirements and addresses your specific product and supplier needs.
Risk Assessment
Conduct a risk assessment of your foreign suppliers and their products.
Documentation Preparation
Prepare all necessary documentation to support your FSVP plan.
Supplier Verification and Audits
Supplier Verification
Assist in verifying that your foreign suppliers are complying with FDA regulations.
Audit Planning
Develop an audit plan for evaluating foreign suppliers, including scheduling and scope.
Audit Execution
Conduct internal audits of foreign suppliers or provide support during supplier audits.
Compliance Documentation
Record Keeping
Ensure proper documentation of all FSVP-related records, including supplier verification activities.
FSVP Documentation Review
Review and organize all documentation required for the audit, including risk assessments and supplier verification records.
Documentation Preparation
Prepare all necessary documentation to support your FSVP plan.
Training and Capacity Building
FSVP Training
Provide training for your team on FSVP requirements, including documentation and record-keeping.
Audit Preparation Workshops
Conduct workshops on preparing for FDA audits, focusing on common pitfalls and best practices.
Corrective Action Plan (CAP) Development
CAP Preparation
Develop corrective action plans for any identified gaps or non-compliance issues.
Implementation Support
Assist in implementing corrective actions and verifying their effectiveness.
Mock Audits
Internal Mock Audits
Conduct mock audits to simulate the FDA audit experience and identify areas for improvement.
Feedback and Improvement
Provide detailed feedback and recommendations to address any issues found during mock audits.
Regulatory Guidance and Support
Ongoing Guidance
Offer ongoing support to ensure continuous compliance with FSVP requirements.
Regulatory Updates
Keep you informed about changes in FDA regulations and guidance related to FSVP.
Audit Day Support
On-Site & Remote Support
Provide on-site support during the FDA audit to ensure smooth communication and address any issues as they arise.
Document Presentation
Assist in organizing and presenting documentation to FDA auditors.
Post-Audit Follow-Up
Audit Report Review
Review and analyze the audit report to identify any issues or areas for improvement.
Response Preparation
Help prepare responses to any observations or findings from the audit.
Continuous Improvement
Develop and implement plans for continuous improvement based on audit findings.
Partner with InterlinkIQ to ensure your FSVP preparation is thorough and effective. Our expert team is
committed to helping you navigate the FDA audit process with ease and confidence. Contact us today to
learn more about our FSVP audit preparation services.
