Objectives

• Learn the purpose, benefits, and objectives of FDA’s Medical Device QSR and QSIT.
• Analyze the meaning of the elements of the QSR.
• Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
• Understand international harmonization efforts and their effects.
• Understand adverse event reporting (MDR) and recall requirements.
• Learn how to read FDA warning letters and recognize situations warranting warnings for QSR deficiencies.
• Map the requirements of the QSR versus your system and establish audit evidence to support FDA compliance.
• Know when design controls are required.
• Plan and prepare for your FDA inspection.
• Understand FDA’s statutory authority.
• Manage your inspection process.
• Follow up after your inspection.
• Understand FDA enforcement actions.

Topics

• The QSR: Integral aspects of the management system
• QSR background and subpart reviews
• MDR and recall requirements
• Recent FDA inspectional observations (483s)
• Introduction to FDA’s QSIT
• Statutory authority and the scope of FDA inspectional powers
• QSIT approach to inspections

Who Should Attend

Designed for those who need to understand and apply the requirements of the QSR, including R&D managers; engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; and other cross-functional team members. Recommended for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with FDA during inspections. Also valuable for anyone who needs to become familiar with FDA Quality System Inspection Technique (QSIT), especially those involved with the four QSIT focus areas: management controls, design controls, corrective and preventive actions, and production and process controls.