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This company speaks 'FDA'
Regulatory compliance consultant snares contracts with Lilly, others
By Peter Schnitzler pschnitzler@ibj.com
Reprinted with permission of The Indianapolis Business Journal
For guidance through the FDA's complex approval process, many life sciences firms turn to Safis Solutions LLC. Its CEO, Ping Poulsen, has spent her whole life navigating new situations.
"You have to put your heart and soul into what you do, and you'll
enjoy the results," she said. Poulsen founded locally based Safis in 2002, originally with the narrow goal of providing information-technology systems validation for biotech companies.
Since then, the company has grown substantially. Today, Safis is a full-service life sciences regulatory compliance consultancy, boasting 20 employees and $4 million in annual revenue.
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Internet International Week of Action Reinforces Anti-counterfeiting Efforts
The Internet International Week of Action (IIWA) resulted in the United States Food and Drug Administration (FDA) issuing twenty-two warning letters to the operators of illegal websites on November 16, 2009. The operation was coordinated by the International Criminal Police Organization (INTERPOL), the World Health Organization's (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and involved law and drug regulatory agencies in 25 countries. This is a significant increase over 2008. Last year, the effort was a day long with 8 countries participating.
Click here for more details about the seizures and steps to avoid counterfeiting.
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Ping Poulsen Participates in Minority Business Growth Program
Ping Poulsen was one of 36 CEOs selected to attend the recent Growing the Minority Business to Scale' program at Dartmouth College's Tuck School of Business. The program is focused on growth as a way for hig -potential companies to achieve their strategic objectives, as well as how to implement an effective growth strategy. This intense six-d program includes classroom learning as well as exercises to put into practice the concepts presented. There was lots of competition among the participants, making the program fun as well as educational.
Competition is very familiar to Ms Poulsen. As an Indiana State Champion in table tennis, she competes on a regular basis.
Click here to read more.
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Upcoming Events
2010 First Quarter Events
January
JAN 26-27: Biomanufacturing Summit 2010 presents "The Key to Operational Excellence is Speed to Market and Process Efficiency "
FEB 3-5: Molecular Medicine Tri-Conference features John F. Crowley as the Keynote speaker. Crowley is the inspiration for the movie "Extreme Measures."
FEB 24: HBA Indiana presents "Healthcare Reform Where are we Now?" panel discussion.
Other Midwest Monthly/Quarterly Events
ASQ Biomedical Division Midwest Discussion Group
For more information about chapter events, please, contact Scott Willis at: Scott.Willis@telamon-corp.com.
IHIF Lunch Conference Series
Meetings are held the third Tuesday of every month from 11:30 - 1:00 PM. For more information, go to: www.ihif.org/pages/lifescience.
Indiana Life Sciences Project Management Group
Information regarding monthly meetings is listed at:
INpact Medical Device Network
Meetings are held in Indianapolis, IN on the third Friday of the month at 11am at Bingham and McHale LLP. For more information, visit: www.inpact.org.
PDA Midwest Chapter
Information about monthly meetings held in Northbrook, Il, and Indianapolis, IN, is listed at: www.pdamidwest.org. |
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Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device, and biotech companies worldwide, to ensure health authority requirements are met. Areas of expertise include: regulatory approval, clinical strategies, quality systems, validation, IT services, auditing, and post-market surveillance programs. Let Safis Solutions help you excel in today's complex regulatory compliance environment.
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This Company Speaks 'FDA'
Internet International Week of Action
Poulsen Attends Tuck School of Business
2010 First Quarter Events
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Bio Corner
Dawn Schofield, CQA, has more than 13 years of Quality Assurance experience within the pharmaceutical and diagnostics industries. Schofield has spent over six years directly supporting drug product development and all phases of Clinical Trial material manufacturing; specializing in qualification, outsourcing and oversight of contract operations for analytical development and testing, manufacturing, label generation, and packaging. She spent her years in the diagnostics industry developing quality systems from the ground up, and maintaining a CLIA compliant laboratory within an ISO certified facility. Schofield's areas of expertise include development and implementation of quality systems, CMO/vendor/supplier qualification and management, GXP and ISO compliance auditing, CAPA and Deviation handling processes, Change Control processes, complaint handling, inspection readiness, and stability program management. Schofield holds a Bachelor's degree in Chemistry from Purdue University, a Bachelor's degree in Merchandising from Indiana University, and is an ASQ Certified Quality Auditor. |
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Don Poulsen plays bass and contrabass clarinets in the Indiana Wind Symphony and the Indianapolis Municipal Band. The 2007 world premier of David Sartor's Veni Emanuel by the Wind Symphony included a rare solo for contrabass clarinet, which Poulsen had the privilege of performing. For information on upcoming performances, see
Indiana Wind Symphony or Indianapolis Municipal Band. |
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How can our newsletters better serve your needs? Please e-mail
Shawn Conway at sconway@safis-solutions.com or call 317-777-6200 ext. 110 with your thoughts.
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