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 [...]
IS/IT Information Systems Management
IS/ IT Information Systems Management A Division of BioTeknica, an IQVIA Business About Our Information Systems [...]
Critical Issue Management
Critical Issue Management for FDA 483 Warning Letters, Recalls & Safety Alerts Agency [...]
Technical Development Service
Medical Device Design Control, Product Development & Quality Testing Product Development Management Design Control Process/Design and Implementation Regulatory Compliance Regulatory, Quality & [...]
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Validation Services BioTeknica, an IQVIA business, provides proven validation methodologies that have been successfully implemented for our clients [...]
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Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for [...]
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 [...]
IS/IT Information Systems Management
IS/ IT Information Systems Management A Division of BioTeknica, an IQVIA Business [...]
Critical Issue Management
Critical Issue Management for FDA 483 Warning Letters, Recalls & Safety Alerts [...]
Technical Development Service
Medical Device Design Control, Product Development & Quality Testing Product Development Management Design Control Process/Design and Implementation Regulatory [...]
Lean Quality Solutions
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, an IQVIA business, offers comprehensive lean quality solutions. [...]
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TEAM MEMBER PROFILE Meet Ruben Capo: Co-Founder, Quality Engineer, Part-Time Adventurer
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INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June 2020 in Phoenix, AZ, has [...]
SUCCESS STORIES Bringing an Inadequate CAPA Process to Effectiveness
Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How [...]
ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?
Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) will share their [...]