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GMP Updates - Enforcement Changes at the New FDA

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Overview 

A UL EduNeering course

US Food and Drug Administration-regulated products—food, drugs, biologics, and medical devices—must be created using good manufacturing practices (GMPs). This course reviews upcoming significant changes in FDA practices, including stepped-up emphases on inspections, warning letters, enforcement, and follow-up. Participants in this course learn about the challenges facing FDA and the industry from outsourced manufacturing and how companies can prepare for the coming changes.

Featured Topics 

  • Current FDA regulatory environment
  • Regulatory enforcement
  • Supply chain and supplier monitoring challenges
  • Risk prevention and future planning in the pharmaceutical, biological, and medical device industry

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Special Offers 

Save by purchasing multiple UL EduNeering eLearning modules at one time. One to two modules cost $99 each, three to four cost $89 each, five to nine cost $80 each, and 10 or more cost $65 each.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

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System Requirements

Webinars/Online Training

To test your system compatibility, click on the link below. http://www.webex.com/lp/jointest/


Operating Systems

 

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit

Mac OS X: 10.5, 10.6, 10.7

Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4


Minimum System Requirements

 

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer, Recommend ActiveX be enabled for Internet Explorer

Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access


Browsers

 

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest

Mac OS X: Safari 4-Mar; Firefox 2/3/3.5

Linux: Mozilla 1.7, Firefox 2/3/3.5


Internet Connection Speed

 

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)

Mac OS X: Intel processor, At least 512 MB RAM

Linux: At least 512 MB RAM

 


Display

 

800x600 pixel resolution or greater (1024x768 pixels recommended).


eLearning


XP Professional SP2 (or later), Windows Vista or Windows 7

Intel Pentium® processor (or compatible) processor 1 GHz

1 gigabyte (GB) of Random Access Memory (RAM)

600 MB of free hard disk space

Graphics card capable of 800 x 600 pixel display with 24-bit color (higher recommended)

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Registration Fees 

Other Fees

Individual
$99.00
Group Discounts

When purchasing multiple UL EduNeering eLearning modules in one transaction, the following discount prices apply:

·          1 to 2 modules are $99.00 each

·          3 to 4 modules are $89.00 each

·          5 to 9 modules are $80.00 each

·          10 or more modules are $65.00 each

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