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Safis Welcomes New Employees  John Nadelin comes to the Safis Solutions with more than 23 years of experience in the industry. As Director of Regulatory & Quality Services, John is responsible for leading a team of compliance advisors and analysts in providing expertise for global regulatory affairs strategy, GxP compliance and computer system validation. He has worked in both start up and large pharmaceutical and device companies. His special expertise and extensive leadership experience is in quality system development, management, and compliance, regulatory affairs, pharmacovigilance and safety surveillance. In addition to those ares, he is also experienced in clinical development, regulatory agency communications, interactions, and inspections, and computer system validation. John received a BS in Computer Science and Philosophy and an MS in Computer Science from Western Michigan University. John also plays bass and keyboards for two local churches.
 Li (pronounced as 'Lee') Rapkin comes to Safis with more than 12 years of experience in the areas of technical communications, quality systems, project management, software systems testing, and web design. She has worked with numerous clients in the Midwest. Some of the roles she has fulfilled have been program manager, project manager, team lead, business analyst, training materials developer, editor, and author. In these roles, she has created or assisted in developing materials such as user manuals and online help, test cases/scripts, business & validation documentation, policies, & procedures, SLAs, RFI & RFP Responses, and a quality maturity model. Ms. Rapkin is also a Registered Yoga Teacher (RYT-200) and has an educational background in Central Eurasian Studies, East Asian Studies, and Radio/TV production. Her rich background in her professional and educational areas will be a tremendous asset to Safis and our clients |
Upcoming Events
2010 Second Quarter Events
June
May
MAY 24-26: American Society for Quality (ASQ) World Conference features Alan Mulally, President and CEO, Ford Motor Company.Robert Stephens, Founder and Chief Inspector, Geek Squad , and Terry Jones, Founder and Former CEO, Travelocity as keynote speakers.
MAY 3-6: BIO International Convention features Dr. Louis Sullivan, Former Secretary of the United States Department of Health and Human Services, Founder Morehouse School of Medicine, and Dr. Regina Benjamin, Surgeon General of the United States, speaking on "Strategic Partnerships: Diversity as a Competitive Advantage
Other Midwest Monthly/Quarterly Events
American Society for Quality (ASQ) Biomedical Division Midwest Discussion Group
Indiana Health Industry Forum (IHIF) Lunch Conference Series
Indiana Biomedical Entrepreneur Network (IBEN)
Indiana Life Sciences Project Management Group
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.
International Society for Pharmaceutical Engineering (ISPE) Great Lakes Chapter
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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Study Linking Autism and Vaccines Retracted
Safis Welcomes New
Employees
News From the Blogs
2010 Second Quarter Events
Other Monthly Events |
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Bio Corner
Steve Wilson is a validation and testing specialist, with unique skills in software and hardware validation in regulated environments. Prior to joining Safis in 2008 as a Compliance Analyst, Steve has over 10 years of regulated industry experience in validation, testing, and technical writing for the life science industry.
Steve has held roles as a software validation and hardware qualification engineer, quality analyst, test lead, copy editor, technical writer, and document management librarian. Steve's areas of expertise include validation, software testing, IQ/OQ/PQ, SOP creation, technical writing, website development, and user guide development. He has experience across the Software Development Life Cycle (SDLC) validation process, spanning from requirements definition to system retirement. He has a particular expertise in database programming languages, including SAS, Oracle, Access, and PL/SQL, and is adept at the Rationale Suite. He also has strong experience in scientific and technical writing for GMP/GCP/GLP quality system SOPs, and regulatory approval documentation. Steve attended the University of Cincinnati, and received an Oracle Database Administration certification from IUPUI.
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Did you Know?
Ping Poulsen was named a 2010 Minority Achievers Award Recipient. The award is given by the Center for Leadership Development.
Eric English and John Lockwood passed the Regulatory Affairs Certification Exam! |
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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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