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The Biggest Mistake Companies Make in FDA Inspections

Richard Vincins has strong feelings about audits and inspections from notified bodies and FDA. What Vincins wants most is for companies to understand the real needs and requirements it takes to prepare for these audits or inspections."The biggest mistake that companies make is not being 'audit ready' or not being prepared for an inspection/audit," says Emergo 's vice president of quality assurance.

 "Companies do not utilize their internal audit process or management reviews to assure they are fully prepared for when an external review is done of their quality system. This is particularly true when they are having annual Notified Body audits and the maintenance of the quality system is not effective, resulting in a poor audit or difficult inspection," he explains.

In some cases, he says, companies might not give themselves enough time to prepare or devote enough resources to the project. "Generally, FDA gives one to two weeks of notification, during which the company should be 'all hands on deck' preparing for the inspection. The company should work diligently in those couple of weeks to ensure that the facility is tidy, quality records are available, and important processes like customer complaints and corrective action have gone through a thorough review," Vincins says.

In a new webcast,Vincins plans to share his wisdom with attendees on the value of proper preparation. Issues addressed will include key differences between inspection and audit processes; setting up mock inspections and audits to prepare a firm for the real thing; and common mistakes to avoid when dealing with FDA inspectors or Notified Body auditors. In addition, the webinar will cover:

  • Dealing with nonconformities
  • Inspection and audit timelines
  • Logistics involved
  • Proper selection of Notified Bodies

Vincins also says that he will explore the latest FDA proposal to give companies an option in choosing either FDA QSR Inspections or having a notified body conduct an audit.The ISO audits are conducted on a yearly basis, while QSR inspections are conducted every 2 years. Of course, QSR inspections are based on FDA availability. Vincins says OEMs should proceed with caution, based on their size and capabilities. "Small to medium size companies may not have an FDA inspection for many years; this voluntary program would basically be giving FDA the company deficiencies annually."

However, medium to large companies might see the program as an opportunity to combine their Notified Body audits with already occurring routine inspections by FDA. "Organizations have to realize that Notified Body audits are performed from a different perspective than FDA inspections, possibly resulting in unwanted regulatory impact when the company's audit report (from the third party) is sent to the FDA," he says.

The Webcast, "How to Prepare for, and Manage, an FDA Inspection or Notified Body Audit," takes place on August 7, 2012 at 2 PM ET | 1 PM CT | 11 AM PT.

—Heather Thompson


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