Regulatory Open Forum

hello all, 
 I am trying to learn more about the requirements for pharmaceutical labeling and artwork management, specifically as related to  what information is required on cartons, foil blister packs, in the PI, etc.
I have been unable to find any sort of course or webcast or book on this topic, either within RAPS, or anywhere else.
I would be extremely appreciative if  you could share any information you may have about this type of resource. 
thank you!

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Susan Shockey RAC
Regulatory Affairs and Quality Management
Mt Pleasant SC
United States
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​There are many different challenges related to labeling!  You might check out Loftware's offerings to see if any of them sound like what you are looking for:

https://www.loftware.com/resources/webinars


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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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Original Message:
Sent: 22-Mar-2018 09:07
From: Susan Shockey
Subject: training on artwork and labeling management?

hello all,
 I am trying to learn more about the requirements for pharmaceutical labeling and artwork management, specifically as related to  what information is required on cartons, foil blister packs, in the PI, etc.
I have been unable to find any sort of course or webcast or book on this topic, either within RAPS, or anywhere else.
I would be extremely appreciative if  you could share any information you may have about this type of resource.
thank you!

------------------------------
Susan Shockey RAC
Regulatory Affairs and Quality Management
Mt Pleasant SC
United States
------------------------------

Hi Susan,

There are some helpful guidances here:

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065010.htm

Specifically, I've found the following very useful:

• Pregnancy, Lactation, and Reproductive Potential (PLLR): Labeling for Human Rx Drug and Biological Products https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm450636.pdf
• Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements https://www.fda.gov/downloads/drugs/guidances/ucm075082.pdf
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (April 2013, Drug Safety) https://www.fda.gov/downloads/drugs/guidances/ucm349009.pdf
• CFR 201.1 Subpart A, General Labeling Provisions: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.1

I've also seen webinars offered sporadically from various artwork/design vendors and FDA highlighting some common issues they've seen. If you work with a vendor, perhaps they can link you up to one they've done in the past or that someone else in their industry has done. 

Good luck!
Courtney

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Courtney Portik
Atlanta, GA
------------------------------

Original Message:
Sent: 22-Mar-2018 09:07
From: Susan Shockey
Subject: training on artwork and labeling management?

hello all,
 I am trying to learn more about the requirements for pharmaceutical labeling and artwork management, specifically as related to  what information is required on cartons, foil blister packs, in the PI, etc.
I have been unable to find any sort of course or webcast or book on this topic, either within RAPS, or anywhere else.
I would be extremely appreciative if  you could share any information you may have about this type of resource.
thank you!

------------------------------
Susan Shockey RAC
Regulatory Affairs and Quality Management
Mt Pleasant SC
United States
------------------------------