Medical Devicemaker Survey on CAPA Practices to be Released April 2012

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FDAnews' forthcoming Medical Device Manufacturer CAPA Benchmarking Survey -- to be released April 2012 -- reveals not just how medical device makers are approaching CAPA investigations and what the industry is experiencing in terms of enforcement, but sheds light on emerging tactics companies are using to get their CAPA programs under control.

Companies and individuals interested in this information can pre-order now ahead of the April 2012 release date.


The US FDA cites device makers for problems with their CAPA systems more often than any other quality system; CAPA accounts for 10% of all the observations on device maker 483s. Why is this one quality system such a continuous source of problems, and what are device makers doing to attack these problems? FDAnews contacted 229 companies, in the first survey of its kind, to find answers.

The survey of device maker best practices for CAPA investigations found some surprising attitudes still prevail in the industry, as well as some innovative new techniques that are aimed at taming CAPA system problems.

Some Key Findings:

- Not My Job Attitude Persists:

Some 33% of device makers said they struggle to get time and commitment from staff outside the quality department, as well as other resources, to help investigate and close CAPAs.

- Root Cause Analysis Skills Remain Weak:

Some 30% of device makers report that their companies lack the ability to effectively conduct root cause analysis the heart of any CAPA investigation.

- CAPAs Are Increasing, Budgets Not:

Companies are reporting by a margin of 2-to-1 that they are seeing an increase in the number of CAPA investigations they initiate each year, but the majority of companies report flat budgets for CAPA investigations.

- Innovative Approaches Emerging:

While CAPA remains a problem, companies are changing their practices to help improve performance with measures such as creating a team approach to managing CAPA investigations and establishing tighter controls when it comes to extending CAPA investigations.

Additional Findings From The Survey Include:

- More than 2/3 of companies surveyed report that CAPA programs are drawing increased attention during FDA inspections, with the results driving change in their organizations
- 63% of device companies have expanded the involvement of senior management in monitoring their company's CAPA programs in the last two years
- Companies are generally not seeing an increase in funding for their CAPA programs, but few companies are having their budgets for CAPA activities cut, despite the economy
- Innovative risk-based, multidisciplinary approaches to CAPA programs are emerging and showing some promise in improving CAPA performance

Buy This Important Survey Now:

Medical Device Manufacturer CAPA Benchmarking Survey is published by FDAnews in print or PDF format for $457.

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FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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