How to Prepare for an FDA Inspection - A Practical Perspective
Duration: 1 Hour
The FDA-regulated industries are among the most heavily regulated businesses in the United States . The authorities becoming stricter every day, FDA investigators often arrive unannounced to perform an inspection to see if organizations are following all of the applicable GxP regulations. The inspection may take a few hours or it may take far longer. No matter what, organizations always need to be prepared for such an inspection. This presentation will provide practical advice regarding how to prepare for these inspections so that your facility will pass with flying colors.
MetricStream's advanced and comprehensive suite of solutions for automating GXP compliance processes has embedded best practices that ensure ongoing compliance with FDA regulations. By improving operational efficiencies in quality systems, MetricStream lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality issues.
Areas Covered in this seminar:
- Critical areas of inspection and how to prepare for them
- Basic survival rules
- Organization & Personnel
- Buildings, Facilities & Equipment
- Controls
- Records & Reports
- Returned and Salvaged Products
- The FD 483 - How to deal with it
Panelists |
David Dills
David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities. David is global industry speaker and author of technical and compliance related topics published in industry journals.
Raghuraj Gaikwad
Manager, FDA Solutions, MetricStream |
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