How to Kick-Start Your CAPA Process

By Ken Peterson, Pathwise

The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. The pressure to put products into the marketplace is undoubtedly intensified by the strict guidelines enforced by the FDA and other regulatory bodies worldwide. Medical device companies are under obligation to meet market demands while complying fully with regulatory requirements.

Over the last couple of years, we have seen a significant increase in warning letters and consent decrees that have in some cases caused a supply chain delay or even plant closure. Every organization understands that an effective corrective and preventive action (CAPA) program is mandatory for doing business while satisfying the FDA guidelines. The bottom line is to find ways to operate effectively within a CAPA system while maintaining profitability.

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