Our industry experts explain FDA's Medical Device Quality System Regulation and what it means to your organization. Learn what compliance with this regulation means, current trends toward harmonization and implementation strategies, the primary impact of the regulation on medical device companies, and how to comply with the requirements. Understand how the regulation compares with ISO 9001 quality system requirements, what FDA inspectors look for on establishment inspections, and how design control, process validation, supplier evaluation, and risk management fit into FDA's Medical Device Quality System Regulation. Discussions include the impact of ISO 9001 and ISO 13485 on the Quality System Regulation and the medical device industry, and the role of the FDA and international standards bodies.

For a complete week of FDA regulatory training, combine this two-day program with our Implementing an ISO 13485 Quality Management System (1 day), FDA Quality System Inspectional Techniques (QSIT) (1 day), and Introduction to Process Validation (1 day).

Objectives

Understand the purpose, benefits and objectives of FDA's Medical Device Quality System Regulation (QSR).

• Analyze the meaning of the elements of the QSR.
• Describe the relationship between applicable standards and guidance documents in support of FDA compliance initiatives.
• Understand international harmonization efforts and their effects.
• Learn how to read FDA warning letters and recognize situations warranting warnings for QSR deficiencies.
• Map into the requirements of the QSR and establish audit evidence to support FDA compliance.
• Know when ISO 13485 compliance is required.

Topics

The Quality System Regulation (QSR): Integral aspect of the management system

• QSR background
• QSR subpart reviews
• Quality system requirements
• Design controls
• Document controls
• Purchasing controls
• Identification and traceability
• Production and process controls
• Acceptance activities
• Nonconforming product
• Corrective and preventive action
• Labeling and packaging control
• Handling, storage, distribution, and installation
• Records
• Servicing
• Statistical techniques
• Recent FDA inspectional observations

Who Should Attend

Designed for those who need to understand and apply a working knowledge of the requirements of the Quality System Regulation, 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.

CEUs: 1.5
Number of Days: 2