Take all 3 classes together and receive more indepth training as well as a discount of $195.

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 9001:2000 and ISO 13485 on the Quality System Regulation and the medical device industry, and the role of the FDA and international standards bodies.

Get the information you need to understand the ISO 13485:2003 and ISO 9001:2000 standards and how they impact your organization. Dynamic group discussions focus on when compliance or registration is required or desirable, how to document and design an effective quality management system, what the revised requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increased productivity, cost effectiveness, higher perceived quality, enhanced internal and external communication, and competitive advantage.

FDA-regulated organizations must establish and maintain a quality system appropriate for the specific medical device being manufactured and meet the requirements of FDA's Medical Device Quality System Regulation. QSIT is intended to increase manufacturer compliance, inspectional consistency, product quality, and the efficiency of the enforcement action review process.

CEUs: 3.8
Number of Days: 5