(FDANews: Falls Church, VA) -- FDAnews has announced details of its upcoming CAPA is King Virtual Conference: Tools, Tips, and Techniques for Assuring Compliance, to be held online Dec., 13, 2011, 10 a.m.–4 p.m. EST.

These days more than two-thirds of all Food and Drug Administration (FDA) warning letters cite corrective and preventive action (CAPA) deficiencies in how a firm conducts related investigations. The FDA doesn’t just look just for compliance, but also for risk. Inspectors want to see that companies are proactively identifying and fixing risks as well. Also, agency investigators now scrutinize CAPAs to trace the dotted lines that connect drug and device sponsors to problems beyond CAPA.

For example, it’s no longer enough for organizations to catch a problem and halt distribution. Now they must track down units that are already in the field—and manage them properly, too.

Developing a successful CAPA program has never been more important. Yet history proves that drug and device firms have a steep learning curve. However, drug- and device-makers that can demonstrate their CAPA programs are effective and adequate are in line for the FDA’s blessing.

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