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  1. Structured Product Labeling Resources

Resources for SPL Commercial Software and Conversion Vendors and FDA-Regulated Company Self-Generated SPL Software Developers

Resources

SPL Implementation Guide with Validation Procedures (PDF)

FDA SPL Schemas (zip file - last updated April 25, 2016)

FDA SPL Stylesheets (zip file - last updated October 24, 2016)

 

SPL Data Standard Training for SPL Commercial Software and Conversion Vendors and FDA-Regulated Company Self-Generated SPL Software Developers

A series of Structured Product Labeling (SPL) data standard training opportunities are being offered to SPL commercial software and conversion vendors as well as FDA-regulated companies which develop SPL software specifically for internal use by their company. 
 

Individual SPL Data Standard Training for SPL Commercial Software and Conversion Vendors or FDA-Regulated Company SPL Software Developers

FDA has adopted the use of extensible markup language (XML) files in SPL as the standard format for the exchange of product and facility information. The focus of these SPL data standard training web conferences will be for tools which create and edit SPL documents for submission to FDA.

Individual SPL training sessions are being offered to afford an opportunity for representatives of SPL commercial software and conversion vendors as well as individual FDA-regulated companies which develop software for their internal use to attend SPL training sessions during which SPL data standards and SPL technical questions specific to their individual SPL software may be asked of the FDA SPL team at a scheduled time agreed upon by the FDA SPL team and the SPL training session registrant. 

The duration of each of these individual SPL data standard training sessions may range from 30 minutes to two hours.

Registration Information

There is no registration fee for the training sessions but pre-registration is required because of limited connections for the webinars. To register, please submit the following information via e-mail to spl@fda.hhs.gov:

Attendee’s first and last name
Name of your organization
E-mail address
Requested duration of SPL training session
Time zone
 

For further details regarding these SPL data standard training sessions, contact: spl@fda.hhs.gov.

 

 

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