Quality By Design, Total Product Life Cycle, and Seven Ways to Improve Design Controls for an FDA Inspection

With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.

Quality by Design (QbD) provides a medical technology company with an enhanced understanding of product quality and a strong basis for risk management. With the increased regulatory flexibility that FDA has been showing in the past several years, this facilitates design of products and processes that maximize a product's efficacy and safety profile. Additionally, using QbD may also enhance product manufacturability. The fundamental approach to QbD understands the relationship between the quality attributes of the product and their impact on the safety and efficacy of the device.

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Avoiding the CAPA Calamity

When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.

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