Medical Device Compliance Congress Proceedings
Source: Institute of Validation Technology
Interpret and Comply with 21 CFR 820 Quality System Regulation
Interpret and Comply with 21 CFR 820 Quality System Regulation Overview of the Medical Device Act of 1976
Review the Safe andMedical Device Amendments of 1990/1992; FDA Modernization Act (FDMA)
Learn the General Provisions for CFR 21 Part 820
Comply with Quality System Requirements
Establish and Maintain Procedures for Medical Device Design Controls
Define the Phases of Risk Assessment Across the Product Life Cycle
Establish Document Controls Required by the Regulation
Establish Purchasing Controls for Your Organization
Identify and Trace Products During All Stages to Prevent Errors
Production and Process Controls: Develop and Implement Processes for Production
Maintain Procedures for Acceptance Activities
Ensure Compliance for Nonconforming Products
Establish Procedures for Implementing Corrective and Preventive Action Program
Establish Procedures for Labeling and Packaging Controls
Learn How to Maintain Handling, Storage, Distribution, and Installation Procedures
Implement Procedures to Maintain Records
Ensure the Servicing for Your Device Meets the Regulation
Learn When/Where Statistical Techniques Should be Used
Review FDA Inspections and Other Relevant Topics
Presentations from all speakers:
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