FDA Drug Compliance

Posted in Press Release on December 20th, 2009 by admin – 1 Comment

ARLINGTON, VA, DECEMBER 18, 2009: VarnerMiller, a training and documentation firm headquartered in Mount Pleasant, SC recently completed a course for the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). The 1.5 hour, web-based course went live on December 18, 2009 and is targeted for a cadre of pharmaceutical manufacturers who market unapproved drugs.

Over the past few years, the FDA has worked to identify and prioritize actions regarding unapproved drugs that have safety concerns, lack effectiveness, or are health frauds in order to uphold its mission of assuring that safe and effective drugs are available to the American people. This approach was intended to be implemented without imposing undue burdens on health care and was applied uniformly against all companies, large and small, that market these unapproved drugs.

In an effort to help explain the drug approval process to pharmaceutical companies, FDA/CDER turned to VarnerMiller to develop a course for manufacturers. The course utilizes video, motion graphics, and 3-D modeling to explain the routes to drug approval. VarnerMiller’s use of industry standard, adult learner focused, training development coupled with innovative approaches work together to engage learners and increase retention.

The project was coordinated through VarnerMiller’s Arlington Office and was awarded through their Office of Personnel Management, Training and Management Assistant Contract. The contract exists to develop training and human capital solutions for government agencies through an expedited contracting process. Overall, the contract manages 500+ projects annually, supports 100+ government agencies, and utilizes 30 pre-qualified commercial contractors.
The final course, Bringing an Unapproved Drug into Compliance, can be viewed at http://fdadrugcompliance.com/.

30th Annual Telly Awards

Posted in Editing on June 26th, 2009 by bobbyearl – Be the first to comment

Telly Awards LogoVarnerMiller has won a 2009 Classic Telly Award for their work on Canine Threats project from U.S. Courts.

The VarnerMiller team is proud to accept their first Telly Award, and add it to their previous Hermes, Videographer and Davey awards.

Congratulations!

Triple Partition a Mac Pro

Posted in Development on June 26th, 2009 by bobbyearl – Be the first to comment

Recently, due to client restraints, we needed to format a single hard drive with three partitions.  Here’s the scenario.

We’re using a Mac Pro. Our multimedia director uses the Mac platform to produce our video content whereas our final delivery is a PC based application.  As you can see the Mac hardware works perfect for this environment, allowing us both to run our respective operating systems natively on the same machine.  This same awesome feature also introduces our delimma.

The video script is prepared as a text document in XP, which means XP needs write access to a location that OSX has read access to.   OSX then needs write access to store the produced video files in a location that XP has read access to.

Although there a few possible solutions to this problem, such as using the FAT32 filesystem to install XP on or using a third-party application, we decided to create three partitions on our hard drive in the following arrangement.

  1. Leopard on Mac OS Extended (Journaled)
  2. Empty FAT32
  3. XP on NTFS

Procedures to create  Apple Journaled / FAT32 / NTFS paritition

  1. Install Leopard onto a single partition using the Mac OS Extended (Journaled) format.
  2. After following all install procedures, launch Terminal from the install DVD.
  3. Type in the following command, but applying your drive names and drive sizes.diskutil resizeVolume [DISK_ID] [DISK_SIZE_0]G “HFS+” [DISK_NAME_1] [DISK_SIZE_1]G “MS-DOS FAT-32″ [DISK_NAME_2] [DISK_SIZE_2]GBased on our scenario above, we ran the following command to equally split our 300GB drive:diskutil resizeVolume disk0s2 100G “HFS+” Data 100G “MS-DOS FAT-32″ XP 100G
     
  4. Restart into OSX, removing the OSX install disc.
  5. Insert the XP installer disc and restart again, making certain to hold the OPTION key during boot.
  6. Select the XP installer disc.
  7. Install XP as normal, making certain to select the “XP” partition and format it as NTFS.
  8. The XP installer will restart the machine during the installation process.  You must hold the OPTION key during the restart and boot to the XP partition.
  9. Allow the XP installer to finish.
  10. Once again, insert the OSX Install DVD and boot to it.
  11. Launch the Disk Utility from the install DVD and highlight the second partition.  In our example above it’s called “Data.”
  12. From the Erase tab, select MS-DOS (FAT) in the Volume Format dropdown and click erase.
  13. Restart and boot into the XP partition.  The OSX installer disc will install the Bootcamp drivers.
  14. Voila.  We have great success.

We hope to eventually add screen grabs.