Background
Regulations
Teva
Technology
Compliance
100
The presenters Name and Company.
Who is Philip Jadd and Xyntek
100
The first 50% of products by NDC or Volume must be serialized and have an ePedigree by this date in California.
What is January 1st 2015?
100
True or False: Teva plans to upgrade packaging lines to meet the new California regulations.
What is True?
100
This item on a unit level product contains variable information, such as serial number, expiration date, and lot number.
What is a 2-D Data Matrix / Barcode?
100
True or False: 21 CFR Part 11 are regulations for Computer System Security.
What is true?
200
This process assigns unique serial numbers to individual items.
What is Serialization?
200
The second 50% of products by NDC or Volume must be serialized and have an ePedigree by this date in California.
What is January 1st 2016?
200
Teva plans to have the first 50% of products by NDC or Volume serialized and have an ePedigree by this date.
What is January 1st 2014?
200
This system is used to inspect 2-D Data Matrices and Human Readable Equivalents on a packaging line.
What is a Vision System?
200
This terms refers to the ability of one system to be able to effectively communicate with any other system.
What is Interoperability?
300
This process refers to following an item at each step during its production, and updating a central database with this information
What is Track and Trace?
300
True or False: California is the only state moving towards serialization.
What is False?
300
Teva plans to have the remaining 50% of products by NDC or Volume serialized and have an ePedigree by this date.
What is January 1st 2015?
300
This multiple camera system is used to commission a 2-D Matrix to a specific bottle.
What is an Omni-View 360 System?
300
This standardized format will be used to code all barcodes.
What is GS1 Standards?
400
This document is a compilation of an item life cycle; from manufacturing, to distribution, to the end user, even returns.
What is an ePedigree?
400
This government body to date has not enacted any federal serialization programs?
What is the Food and Drug Administration or FDA?
400
The first serialized pilot line happened in this manufacturing plant.
What is Forest Virginia?
400
The ability to do Bulk Reads of unique identifiers is a characteristic of this technology.
What is RFID Technology?
400
cGAMP stands for this.
What is Computerized Good Automated Manufacturing Process?
500
These 5 countries have already established nationwide serialization programs.
What are Belgium, Italy, France, Greece, and Turkey
500
Regulations were put into place because this percentage of drugs in the USA were found to be counterfeit.
What is 1%?
500
This department has already put in place much of the infrastructure for serialization on the enterprise level.
What is the Teva IT Department?
500
This software is in charge of managing all of the information as it goes to and from the line devices all the way to the enterprise servers.
What is the Line Control Software?
500
In order to initiate the validation process this document must first be prepared.
What is a Change Control?
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