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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.
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.
Attendees of the web conferences and face-to-face training session should be individuals responsible for registering drug establishments and listing drug products.
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:
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.
Module # |
Title |
Date |
Time (EST) |
---|---|---|---|
1 |
NDC Labeler Code |
Wednesday, February 4, 2009 |
11:00 – 11:30 a.m. |
2 |
Establishment Registration – Domestic Establishments |
Wednesday, February 11, 2009 |
11:00 a.m. – 12:00 p.m. |
3 |
Establishment Registration – International Establishments |
Wednesday, February 18, 2009 |
11:00 a.m. – 12:00 p.m. |
4 |
Content of Labeling |
Wednesday, February 25, 2009 |
11:00 a.m. – 12:00 p.m. |
5 |
Product Listing Data Elements |
Wednesday, March 4, 2009 |
11:00 a.m. – 12:00 p.m. |
6 |
Submitting SPL R4 v Documents via FDA Gateway |
Wednesday, March 11, 2009 |
11:00 – 11:30 a.m. |
Module # |
Title |
Date |
Time (EST) |
---|---|---|---|
1 |
NDC Labeler Code |
Wednesday, March 18, 2009 |
11:00 – 11:30 a.m. |
2 |
Establishment Registration – Domestic Establishments |
Wednesday, March 25, 2009 |
11:00 a.m. – 12:00 p.m. |
3 |
Establishment Registration – International Establishments |
Wednesday, April 1, 2009 |
11:00 a.m. – 12:00 p.m. |
4 |
Content of Labeling |
Wednesday, April 8, 2009 |
11:00 a.m. – 12:00 p.m. |
5 |
Product Listing Data Elements |
Wednesday, April 15, 2009 |
11:00 a.m. – 12:00 p.m. |
6 |
Submitting SPL R4 Documents via FDA Gateway |
Wednesday, April 22, 2009 |
11:00 – 11:30 a.m. |
Module # |
Title |
Date |
Time (EST) |
---|---|---|---|
1 |
Electronic Drug Establishment and Drug Listing Face-to-Face Training |
May 21, 2009 |
9:30 a.m. – 3:30 p.m. |