The Importance of Process Validation: Lessons from Recent FDA Warning Letters
How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical requirement for medical device manufacturers. The FDA routinely issues Form 483s and Warning Letters when companies fall short in this area, underscoring the importance of robust validation protocols. Since 2020, there have been at least 43 documented instances where the FDA cited non-compliance with a key regulatory requirement: “Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR §820.75(a).” Recent Examples Highlight Common Validation Pitfalls Here are two examples of common validation pitfalls we see highlighted in Warning Letters. In the first, a manufacturer of diagnostic devices received a Warning Letter after an FDA inspection [...]
The Importance of Process Validation: Lessons from Recent FDA Warning Letters
How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical requirement for medical device [...]
Due Diligence and Quality Systems Integration… More Important than Ever
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The Importance of Process Validation: Lessons from Recent FDA Warning Letters
How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical requirement for medical device manufacturers. The [...]
The Importance of Process Validation: Lessons from Recent FDA Warning Letters
How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical [...]
Due Diligence and Quality Systems Integration… More Important than Ever
Due Diligence and Quality Systems Integration… More Important than Ever during Tumultuous Period for Pharmaceutical and Medical Device [...]
IS/IT Information Systems Management
IS/ IT Information Systems Management A Division of BioTeknica, an IQVIA Business [...]
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