With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.