FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

SPL Release Four Training Sessions
Preparing Electronic Drug Establishment Registration
and Drug Listing Submissions

A series of Structured Product Labeling (SPL) Release Four training sessions are being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA.

Background

The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. The focus of the web conferences will be the preparation of the SPL Release Four documents. The face-to-face discussion will provide more in-depth information about the preparation of the documents and the relationships of the data in each document.

Target Audience

Attendees of the web conferences and face-to-face training session should be individuals responsible for registering drug establishments and listing drug products.

Registration Information

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

1. Attendee’s first and last name
2. Name of your organization
3. Name and date of training session(s) for which you are registering.

You will be limited to one phone/web conference line per company. Due to space limitations, only two individuals per organization will be permitted to attend the face-to-face meeting.

For further information, contact: spl@fda.hhs.gov.

Session 1 – February 4, 2009 – March 11, 2009, Web Conferences
Session 2 – March 18, 2009 – April 22, 2009, Web conferences
Session 3 - May 21, 2009, Face-to-Face – Rockville, MD, Room TBD, 9:30 a.m. – 3:30 p.m.

Session One (Web Conferences)

Session Two (Web Conferences)

Session Three (Face-to-Face)

Home Page

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff