As of June 1, 2009, the FDA requires establishment registration and drug-listing data in a fully electronic format known as structured product labeling (SPL). This guidance applies to all prescription pharmaceutical, biological, OTC, and veterinary medicine producers and distributors. The implementation of SPL will eliminate the creation of paper forms, which duplicated information already contained in product labeling.

As industry continues to provide more electronic labeling information, the FDA is able to decrease the amount of proofreading of paper submissions, thereby decreasing the chances of human error. This audio conference explores how SPL allows for electronic technology to capture this information, decreasing the potential for human error in transcription and increasing efficiencies.

This audio conference covers:

• Who is impacted by this guidance
• What needs to be done to submit in SPL format
• What solutions exist to assist with this guidance
• How are SPL submissions delivered
• What new information is needed
• When will SPL submissions need to be delivered

About the speaker:

Craig Trautman is the CEO of Intagras, a company that provides application development, SPL management and business process consulting. He is responsible for carrying out the strategic plans and policies established by the Intagras board of directors, as well as the day-to-day management of business development, organization direction, project decisions, human resources and accounting.

Prior to co-founding Intagras in 2005, Craig spent several years as a contributor on the FDA SPL working group and testing team. As a project manager, he led several XML and SPL initiatives for other government agencies, including the U.S. Defense Intelligence Agency (DIA), the Office of Naval Intelligence (ONI), and the UK Ministry of Defense. Craig is currently part of the SPL Leadership Team, which continues to work with and advise the FDA on current and future implementations of the SPL initiative.

Who should attend?

• Regulatory Affairs
• Labeling
• Chemical Manufacturing and Controls
• Listing and Registration
• Operations
• Artwork & Graphics