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U.S. Department of Health and Human Services

Science & Research

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SPL Release Four Training Sessions 2009

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. 

Target Audience

Attendees of the web conferences 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. 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. Session name and date of training session(s) for which you are registering.

You will be limited to one phone/web conference line per company. 

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

2009 SPL Training Sessions

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 4 - February 5, 2009 - March 12, 2009, Web conferences
Session 5 - March 19, 2009 - April 23, 2009, Web conferences
Session 6 - February 23, 2009 - March 19, 2009, Web conferences
Session 7 - April 29, 2009 - June 3, 2009, Web conferences
Session 8 - June 10, 2009, Face-to-Face – Rockville, MD, Room TBD, 9:30 a.m. – 3:30 p.m.
Session 9 - April 30, 2009 - June 4, 2009, Web conferences
Session 10 - June 11, 2009 - July 16, 2009, (Thursdays - See table for times) Web conferences (Registration Full)
Session 11 - July 30, 2009 & August 6, 2009, (Thursdays - See table for times) Web conferences (Date Change) (Registration Full)
Session 12 - August 20, 2009 & August 27, 2009,  (Thursdays - See table for times) Web conferences (Date Change) (Registration Full)
Session 13 - June 30, 2009 - Compressed Gas Drug Products - Electronic Drug Establishment Registration and Drug Listing in SPL Format - Face-to-Face & Web Conference – Rockville, MD, Room TBD, 10:30 a.m. – 3:30 p.m. 
Session 14 - June 19, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions
Session 15 - June 26, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submissions  (Registration Full)
Session 16 - June 26, 2009, Web Conference 11:30 a.m. - 12:30 p.m. - SPL R4 Training - Accelerated Course - Preparing SPL R4 Documents
Session 17 - June 26, 2009, Web Conference 1:00 - 2:30 p.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions
Session 18 - July 15, 2009, Web Conference 11:30 a.m. - 12:30 p.m. - SPL R4 Training - Preparing Repacked Drug Product Electronic Drug Listing Submissions
Session 19 - August 5, 2009, Web Conference 11:30 a.m. - 1:00 p.m. - SPL R4 Training - Preparing Combination Product Electronic Drug Listing Submissions (Date Change)
Session 20 - July 8, 2009, Web Conference 11:30 a.m. - 12:00 p.m. - SPL R4 Training - Common Errors in SPL R4 Submissions
Session 21 - July 8, 2009, Web Conference 1:00 - 2:30 p.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submission
Session 22 - July 28, 2009, Web Conference 11:00 a.m. - 12:30 p.m. - SPL R4 Training - Preparing Homeopathic Drug Product Electronic Drug Listing Submissions

Session 23 - September 10, 2009, & September 17, 2009, (Thursdays - See table below for times) Web conferences (NEW!)

Session 24 - October 1, 2009, & October 8, 2009, (Thursdays - See table below for times) Web conferences (NEW!)

 

 

Module #

Title

Days

Time (EST)

1

SPL 101

SPL Overview

NDC Labeler Code 

Establishment Registration

Content of Labeling

Product Data Elements

Submitting SPL Documents via FDA Gateway

Fridays 1:00 p.m. - 3:00 p.m., ET
2

SPL Advanced

Data Relationships

Updating SPL Data

Common Technical Errors

Scenarios

Fridays 1:00 p.m. - 3:00 p.m.,