FDA Training Sessions for 2011: Slide Sets


The FDA Data Standards Council’s website was updated Tuesday, January 18, 2011, to announce the 2011 SPL training session schedule: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm

Please note that the sessions are scheduled from January - June 2011 and from September - December 2011. Currently, there are no SPL training sessions scheduled for July and August 2011. Also, two of the sessions will be dedicated to specific topics the SPL authoring vendors may discover to be helpful. However, attendance for these two sessions are not restricted to the software vendors.

Slide Sets from 2011 Trainings


SPL Authoring Tool Vendors
Session #56 - March 14, 2011

Positronic Emission Tomography SPL
March 8, 2011
PET Drugs Training
Bulk Ingredient/Bulk Product SPL
Session 52: February 7, 2011
Session 58 - March 28, 2011
Session 61 - April 18, 2011

OTC Presentations
Session # 51: January 31, 2011
Session # 57 - March 21, 2011
Session # 60 - April 11, 2011

Labeler Codes and Establishment Registration
Session # 50: January 24, 2011
Session # 55 - March 7, 2011

Homeopathic Drug Product SPL
Session # 64 - May 9, 2011

Prescription Drug Product SPLSession # 66 - May 23, 2011

Repacker/Relabeler SPLSession # 66a - May 23, 2011

2011 SPL Training Sessions Schedule


The future 2011 SPL training sessions are scheduled Mondays from 11:30 a.m. - 12:30 p.m., ET on the following dates:

Session 67 - June 6, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 68 - June 13, 2011 - Bulk Ingredient/Bulk Product SPL
Session 69 - June 27, 2011 - Prescription Drug Product SPL
Session 70 - September 12, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 71 - September 19, 2011 - Homeopathic Drug Product SPL
Session 72 - September 26, 2011 - Prescription Drug Product SPL
Session 73 - October 3, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 74 - October 17, 2011 - Bulk Ingredient/Bulk Product SPL
Session 75 - October 24, 2011 - OTC Drug Product SPL
Session 76 - October 31, 2011 - Prescription Drug Product SPL
Session 77 - November 7, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 78 - November 14, 2011 - SPL Authoring Tool Vendors (for SPL software vendors and other interested entities)
Session 79 - November 21, 2011 - OTC Drug Product SPL
Session 80 - December 5, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 81 - December 12, 2011 - Bulk Ingredient/Bulk Product SPL
Session 82 - December 19, 2011 - Prescription Drug Product SPL

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 [[mailto: spl@fda.hhs.gov|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: [[mailto: spl@fda.hhs.gov|spl@fda.hhs.gov]].