Training


Resources

SPL Roadmap (a guide to getting started with SPL R4):

SPL eBooks available here.
SPL eCards available here.

new! 10-Jan 2013
2013 FDA Training Sessions Schedule
FDA SPL Tech Q&A Sessions - 1-on-1 between company rep and SPL team

Beginning Monday, May 21, 2012, we will be offering 1:1 (FDA SPL Team & SPL document author) 15-minute SPL Technical Q&A sessions. These SPL Tech Q&A teleconference 15-minute sessions will afford an opportunity for a company representative to attend an SPL Tech Q&A session to ask SPL technical questions at a scheduled time agreed upon by the FDA SPL team and a company representative. The Monday SPL Tech Q&A group sessions will still be held and questions may still be e-mailed to spl@fda.hhs.gov.

Registration for these sessions begins on Monday, May 21, 2012. Registration requests for these sessions received prior to Monday, May 21, 2012, will receive a response which includes a note about the May 21, 2012, start date.

To request a session, please follow these instructions:

Send an e-mail to spl@fda.hhs.gov with the following information:

Subject line of e-mail: Request for 1:1 SPL Tech Q&A 15-Minute Session - [Company Name]
Body of e-mail:

1. Name of company
2. Name of contact person
3. Time Zone
4. Country
5. List of SPL technical questions

Following these instructions will ensure that the SPL team can efficiently respond to and schedule SPL Tech Q&A 1:1 teleconferences as soon as possible.

Reminder: Registration for these sessions begins on Monday, May 21, 2012.

FDA SPL Tech Q&A Sessions

Information for the SPL technical Q&As audio conference.
Day of the Week: Mondays (except federal holidays or when the federal government in the Washington DC metropolitan area is closed due to inclement weather or other reasons)
Time: 11:00 a.m. - 11:30 a.m., ET.
Location: Audio conference
Audio Conference Details: Telephone number: 1-866-775-9435/Participant pass code: 5753366

The time was altered from 10:00 a.m., ET (7:00 a.m. PT) to permit drug companies located in the Pacific time zone to attend the call beginning at 8:00 a.m., PT.

Presentations from Previous Years' Training

2012
2011

2010

20092008:

SPL Xforms Traing Video Series


SPL Xforms Training Videos - Group A - Basic Instructions for Using the SPL Xforms


Part One - Intro to the SPL Xforms & Buttons/Tabs

Part Two - Types of Xforms Fields & Selecting a Template


Part Three - Document Tracking Information


Part Four - Saving SPL Files


Part Five - Validating an SPL File Using SPL Xforms


Part Six - Updating an SPL File

Module


Two Series of webinars on specific aspects of SPL R4 creation and transmission - not specific to particular areas of industry

Animal Drug - Electronic Drug Establishment Registration and Drug Listing in SPL R4 format training session - February 17, 2009

Individual sponsor FDA sessions

-GPhA Webinars and/or On-site Training



-DIA Webinars and/or On-site Training



-Other Webinars and/or AudioConferences and/or On-Site Training