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Safis recognized as one of Indiana's Companies to Watch
Safis Solutions will be recognized as one of the 2009 Indiana Companies to Watch, at the August 27th awards program presented by the Indiana Economic Development Corporation, Indiana's Small Business Development Center, Purdue University, and the Edward Lowe Foundation. Indiana Companies to Watch is an awards program that celebrates high performing, second stage companies that are known for their performance in the marketplace, innovative products, unique processes or philanthropic actions. Click here to view the list of all of the awardees.
"Large companies creating hundreds of new jobs make headlines, but it's the hard work and determination of Indiana's small businesses that continue to drive Indiana's economic growth."
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Family Smoking Prevention and Tobacco Control Act
On June 22, 2009, President Barack Obama signed the most sweeping piece of tobacco regulation in the history of the United States - the Family Smoking Prevention and Tobacco Control Act of 2009 "the Act" which gives the FDA broad regulatory authority over the manufacturing, labeling and marketing of tobacco products. With this new authority, the FDA could ban chemicals commonly used in tobacco products, restrict advertising, and regulate product labeling. Julie Dykstra of Barnes & Thornburg, LLP and Gretchen Bowker of Safis Solutions raise the question of whether this regulation will effectively improve public safety. Click to read Part 1 and Part 2 of their articles.
Will the FDA's new responsibility for tobacco regulation impair its ability to regulate drugs and devices? Cast your vote on the tobacco poll!
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Safis staff member to share her extensive experience at two upcoming conferences
On August 6th, Gretchen Parker, Ph.D., RAC, will present "Device Development 101-What do you need to know?" at the Center for Assistive Technology Entrepreneurs' Boot Camp. This Indianapolis, IN, event will bring together technology innovators, educators, investors, and users to provide an informative discussion about the development of assisted living technologies.
In addition to the above conference, Parker will also be presenting at the upcoming RAPS Annual Conference in Philidelphia, PA, on September 14, 2009. Speaking to regualtory professionals from around the world, Parker will review the regulatory approval process for multiple international markets, with special emphasis on differences in the areas of clinical trials and adverse event reporting. |
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Safis welcomes three new members to our team
Safis has recently hired three new employees to enhance our ability to reach and support our clients. We are pleased to welcome Michele Ware (Director of Business Strategy), David Tribbett (Compliance Advisor), and Jerry Horn (Senior Sales Executive) to our team.
Michele Ware
Michele joins Safis Solutions with more than 20 years of business experience at organizations like Roche Diagnostics, Xerox, and the University of Maryland UC-Europe. Joining the Senior Management of the organization, Michele will utilize her experience in general management, international marketing, and systems integration to help Safis strategically position itself for long term success, assisting Life Science companies with regulatory and compliance services.
David Tribbet
As a Compliance Advisor, David brings more than 17 years of quality assurance and operations experience within the medical device industry. His areas of expertise include product development, design control and commercialization, supplier qualification and management, CAPA, acceptance activities, process validations, inspection readiness, and software validation. David has extensive auditing experience related to ISO 13485, 21 CFR part 820, and 21 CFR part 11. He has served as a team lead for the hosting of FDA inspectors during the audit of a medical device company and has performed internal and third party supplier audits.
David holds a Bachelor's degree in Chemistry, and a Master's degree in Information and Communication Sciences from Ball State University.
Jerry Horn
Jerry brings over 30 years of sales experience to Safis Solutions in a variety of industries including pharmaceuticals, medical devices, and consumer products. Joining the sales and marketing team, Jerry will leverage his experiences working for organizations like Eli Lilly, Guidant, and Cosco to help drive both the national and international growth of Safis Solutions. |
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Upcoming Events
August
AUG 6: CAT Entrepreneurs' Boot Camp
Experienced professional investors, venture professionals, and valuation experts will provide an informative backdrop for developing assistive technologies in Indianapolis, IN. Click here for more details on this event.
AUG 21: Parental Drug Association Golf Outing
An opportunity to join a local PDA chapter for its Annual Golf Outing in Wheeling, IL. Click here for more details on this event.
AUG 21: Next INpact Meeting
These meetings are held the third Friday of each month at Bingham and McHale in Indianapolis, IN. Meetings are only open to INpact members. Visit INpact's website.
AUG 25: INpact Open House in Indianapolis
This open house provides an opportunity to learn more about INpact's mission and networking opportunities. Visit INpact's website.
AUG 27: Awards Ceremony for Indiana Companies to Watch
This gala honors awardees at the Indiana Roof Ballroom in Indianapolis, IN. Event registration and information is listed at the following http://www.indianactw.eventbrite.com/.
September
SEPT 13-16: Regulatory Affairs Professional Society Annual Conference
This event in Philadelphia, PA, will feature key note speakers Dr. Margaret Hamburg, FDA commissioner, and Jim Collins, author of Good to Great. Visit event website.
SEPT 14-18: Parental Drug Association/FDA Joint Regulatory Conference
This conference in Washington, D. C., provides an opportunity for FDA representatives and industry experts to engage in face-to-face dialogues regarding current regulatory issues in the Life Science Industry. Visit event website.
October
OCT 6-8: Orthopedic Design and Technology Annual Conference
This two-day conference in Fort Wayne, IN, provides the opportunity for orthopedic manufacturers, designers, and surgeons to interact. Visit event website.
OCT 16: Parenteral Drug Association Midwest Chapter Annual Indianapolis Meeting
This all day event at Lilly MQLC will focus on sterilization and quality agreements. E-mail pdamidwest@yahoo.com or visit http://www.pdamidwest.org/ for more information.
OCT 22: Indiana Medical Device Manufacturers Council
This conference will explore the changing landscape for the medical device industry. E-mail imdmcoffice@ameritech.net for details.
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 every third Friday of the month at 11am at Bingham and McHale. For more information, go to: 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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Will the FDA's new responsibility for tobacco regulation impair its ability to regulate drugs and devices?
Click Here to vote and see what others think.
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John Lockwood, CQA, joined Safis Solutions in 2008 as a Senior Compliance Advisor. He is a seasoned product development leader, quality assurance specialist, and exceptional auditor. Lockwood has 15 years of experience providing quality management systems, design control methodologies, supply chain assessments, auditing, device and diagnostic product development planning, and quality compliance. His certifications include Six Sigma Green Belt, ISO 13485 Lead Auditor Training, C.P.M., and CQA. Lockwood holds a Bachelor's degree in chemistry from the University of Illinois.
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Senior Sales Executive Jerry Horn saved a drowning eight-year-old boy at the docks of Four Winds Marina in Bloomington, IN.
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How can our newsletters better serve your needs? Please e-mail
Scott Hartman at shartman@safis-solutions.com or call 317-777-6200 ext. 110 with your thoughts.
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