CAPA management is integral to process control efforts conducted by medical device organizations to adhere to FDA and cGMP regulations. The consequences of CAPA non-compliance are costly and significant, resulting in damaged brand reputation and, potentially, a company’s long-term profitability.
FACT: Poor CAPA implementation is one of the top reasons why regulated
companies receive FDA 483's.
FACT: More than 50% of the warning letters issued to drug and device firms
last year cited Corrective & Preventive Action (CAPA) violations.
So why are so many companies struggling to achieve and maintain compliance? How can you do it right?
Join Leigh Weintraub, COO, Merit Medical, and discover how a successfully implemented CAPA Management Solution helps Merit Medical remain compliant by:
4Avoiding deviations from cGMP and industry regulations, thereby
controlling the cost of non-compliance
4Implementing an active method to search for problems and uncover
problems close to the source
4Addressing the root cause of unplanned variability
4Capturing deviations from different sources in a consistent, centralized
manner
4Coordinating and providing visibility for causal analysis and corrective
actions across all your locations
Hear from Leigh Weintraub and Pilgrim Software how you can build “right first time” quality into your business processes. Your patients and shareholders will thank you.
Who should attend this Webinar?
RA/QA, IT, Operations
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About Merit Medical
Merit Medical Systems, Inc. (NASDAQ, MMSI) develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals.