Exploring FDA Findings Around Calibration

In this whitepaper you will learn:

• FDA Calibration Requirements: Understanding the FDA’s requirements for calibration and maintenance of equipment, including the need for regular calibration and inspection, precise procedures, and traceability to national or international standards.
• Common FDA Findings: Insight into common calibration-related citations by the FDA, such as lack of calibration, procedural issues, and equipment maintenance problems, supported by real data and examples from recent inspections.
• Best Practices for Calibration Programs: Guidelines for developing a comprehensive calibration program that meets FDA regulations, emphasizing the importance of bracketing calibration methods and maintaining accurate records.
• Practical Guidance and FAQs: Answers to frequently asked questions regarding calibration intervals, equipment tolerances, out-of-tolerance requirements, and training, providing practical advice for businesses in regulated industries.