Q: What is involved in the initial consultation and assessment for FSVP audit preparation?
A: We begin with an initial consultation to understand your current FSVP compliance status. Our team conducts a readiness review to evaluate your existing processes and identify any gaps that need addressing.
Q: How do you analyze regulatory requirements for FSVP?
A: We thoroughly review the FDA requirements for FSVP to ensure you meet all necessary standards. This analysis helps align your processes with regulatory expectations.
Q: What does supplier evaluation entail?
A: We assess the adequacy of your foreign suppliers’ compliance with FDA regulations, ensuring they meet required standards and practices for safe and compliant imports.
Q: How do you develop an FSVP plan for my company?
A: We create a tailored FSVP plan that addresses your specific product and supplier needs. This includes risk assessment, documentation preparation, and strategies for meeting FDA requirements.
Q: What is included in the risk assessment process?
A: Our team conducts a comprehensive risk assessment of your foreign suppliers and their products to identify potential risks and ensure they are adequately managed.
Q: How do you assist with documentation preparation for the FSVP audit?
A: We prepare all necessary documentation to support your FSVP plan, including risk assessments, supplier verification records, and other compliance-related paperwork.
Q: What is your approach to supplier verification and audits?
A: We assist in verifying that your foreign suppliers comply with FDA regulations, develop audit plans, and conduct internal audits or support external audits of suppliers.
Q: What training do you provide for FSVP requirements?
A: We offer training for your team on FSVP requirements, including documentation, record-keeping, and best practices for navigating FDA audits.
Q: How do you support the implementation of corrective actions?
A: We develop corrective action plans for any identified gaps or non-compliance issues and assist in implementing and verifying their effectiveness.
Q: What are internal mock audits, and how do they help?
A: We conduct internal mock audits to simulate the FDA audit experience, identify areas for improvement, and provide detailed feedback and recommendations to enhance your readiness.
Q: How do you provide support during the actual FDA audit?
A: We offer on-site or remote support during the FDA audit, helping with communication, document presentation, and addressing any issues that arise.
Q: What happens after the FDA audit?
A: We review the audit report, prepare responses to any findings, and help you develop and implement plans for continuous improvement based on the audit results.
Q: How do you keep clients informed about regulatory updates?
A: We provide ongoing guidance and keep you updated on changes in FDA regulations and guidance related to FSVP, ensuring your compliance efforts remain current.
Q: How can I get started with your FSVP audit preparation services?
A: Contact us to schedule an initial consultation. We will assess your needs, develop a customized plan, and guide you through every step of the FSVP audit preparation process.
Ensure your FSVP program is audit-ready and robust—let our experts help you tackle every challenge with confidence and clarity.
