FX Conferences is proud to be the leader in providing convenient distance learning opportunities designed for busy professionals. We partner with leading industry experts to bring you key information and guidance on the latest challenges and hot topics, and our audio conference format makes it easy to participate from the office, at home or on the road. Feel free to browse through our list of coming events, or use our search feature to review past live presentations now available as recordings.

Search By
Industry
Department

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions

Audio conference highlights


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


Speaker & Time

Craig Trautman, Intagras
Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions
Title: CEO
Duration: 60 minutes
Discount: Buy 2 items, get 25% off your order using coupon code FX25%OFF
Event Type: Previously recorded on 2009-07-14
Item #: ac20090714
14 Jul 2009 
Registration Price:
$249.00

Order Info

Select Order Type:  
Include Transcript With Order?:  
Quantity
More
Less
 
 
Bookmark and Share reviews

Reviews

Average Rating: (based on 4 reviews)

Showing 4 Reviews:

by G.G.
Manager, Regulatory
The speaker was very knowledgeable of the subject and covered all the needed topics in a reasonable amount of time.
by K.G.
Compliance Manager
Good information on what is needed even though it is not easily achievable.
by C.G.
Scientist
Overall, the speaker and content were excellent.
by K.S.
Regulatory Specialist
The speaker was great. I could sense his enthusiasm in the subject.
Rate this item
Similar Events
The Present and Future of SPL & PIM
Mark Bayer & Gary Saner, Reed Technology & Information Services
More about The Present and Future of SPL & PIM


More about Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway


Good Reprint Practices: What the FDA Says Now
Robert J. Klepinski, Fredrikson & Byron
More about Good Reprint Practices: What the FDA Says Now

 
Recently Viewed
© Copyright 2010
ForeignExchange Translations.
All rights reserved.

Home  |   FAQ  |   Blog  |   Translation Services  |   Search  |   Privacy Policy  |   Terms of Use  |   Contact Us