ASQ Section 509 April General Meeting  

ASQ 

Carla Brooks

Presentation on

“Improving the Labeling Translation Process”

Thursday, April 21, 2011
At the
The Golden Bull Restaurant
  in
Gaithersburg, MD

Registration & Networking:  6:00 p.m.  . 

Dinner      7:00 p.m

General Announcements  8:00 p.m.

Program  8:15 p.m.

 Adjourn 9:15 p.m.

The cost is $25.00 for members and students or $35.00 for non-members.

Please register through our website at General Meeting Registration - April 2011 or by contacting Mrs. Michele Withnell at (301) 461-2469 or Arrangements@asq509.org.  Please note:  Meal preferences cannot be guaranteed if one is not registered by Tuesday, April 19, 6:00pm. You may attend the presentation without attending the dinner.

Important Notice: ASQ Section 509 is responsible for the meals for all “No shows” at The Golden Bull Restaurant.  Please help us control our losses by notifying our         Arrangements Chair Mrs. Michele Withnell at Arrangements@asq.org to cancel your dinner prior to the event.  Thank you for your cooperation!

Program Summary:

A key area for improvement identified from an overarching process Kaizen Blitz was translation of materials.  The Kaizen Blitz concluded that translating materials into other languages was costly, time-consuming and all too often resulting in rework due to errors.  At the time, if you interviewed any of the stakeholders about translating pieces, it was clear that frustration levels were high and the perception was that it took at least twice as long to translate things into Spanish, for example. This presentation will show how Lean/Six Sigma tools helped to reduce cycle time and improve quality of translated materials by an average of 8 weeks.

Speaker Biography:  
Carla Brooks is a member of the Regulatory Affairs Advertising and Promotional Compliance team responsible for managing the regulatory promotional reviews and submissions for MedImmune  products to FDA.  Prior to joining the Ad/Promo team, Carla held compliance and quality-focused positions of increasing responsibility at MedImmune and Strategic Diagnostics.  Carla’s experiences have included manufacturing quality control lot release testing, GXP quality assurance, preclinical translational scientific research, clinical development and post-approval marketing compliance, giving her insight into a wide spectrum of the biopharmaceutical product lifecycle.  Carla is Regulatory Affairs Professionals Society Certified (RAC - US), has an MS in Biotechnology from Johns Hopkins University, and a BS in Biology from Morgan State University in Baltimore, MD.

DIRECTIONS TO THE GOLDEN BULL
From Rt. 495. Go N. Rt. I-270 (in Maryland). Take Exit 11 off of I-270 East onto Route 124 (Montgomery Village Avenue). Make the first right at the intersection of Route#355 (Frederick Avenue). Go South on Frederick Avenue 0.5 miles. Make right turn onto Dalamar Street to #7 Dalamar Street.
From the intersection of Shady Grove Road and Frederick Avenue (Rt. 355) (in Maryland). Go North on Frederick Avenue about seven miles. Crossover overpass. Continue North to Dalamar Street, and then turn left onto #7 Dalamar Street. Ample parking is available at restaurant.