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If I am a virtual company, why do I need a Quality System?
Authored by: Gretchen Bowker Director of Regulatory Affairs and Compliance Services
Many virtual companies feel they do not require a quality system as as much of the regulated work is outsourced to other vendor companies. Shouldn't the CMO, CRO, or Laboratory have an adequate quality system to ensure the regulations are met? While this is true on paper, it is not the expectation in practice. Both the FDA and the European Health Authorities have been clear that they expect the Sponsor to take responsibility for the oversight of all contracted vendors. This is generally accomplished by a documented, proceduralized, quality assurance audit of the vendors. So, even a virtual company of a few people will need to have a quality system that documents the vendor oversight process.
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Safis consultant shares her extensive expertise in regulatory affairs by authoring a biologics course for RAPS' Online University.
Safis' very own Gretchen E. Parker, Ph.D., RAC, is a senior faculty member for the Regulatory Affairs Professionals Society (RAPS) Online University. Regulatory professionals throughout the world access and utilize RAPS Online University's self-paced courses to enhance their knowledge and expand their skills.
Senior Faculty members act as a course lead for at least one project team and assist with the identification, recruitment and management of additional experts for their team(s). Together, project teams are responsible for the composition of content for a specific course.
As a Senior Faculty member, Gretchen has developed content for a new RAPS online university Biologics course, in collaboration with other regulatory professionals worldwide. Other authors include Beate Schmidt, Bob Ezzell, and Usha Srinivasan. Stay tuned for more information and a link to the course once it is published. |
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Safis Welcomes Ashton Clark and Scott Hartman
As a consulting company, we know the importance of hiring the best talent. Therefore, we recently hired Ashton Clark as a Validation and IT Services Program Manager. At Safis, Clark will oversee all validation and IT services projects for various clients.
Clark is a proven leader, with over 25 years of experience within operations, manufacturing, IT, and business development functions within the life sciences, healthcare, insurance and telecommunications industries. Clark is an expert in the field of validation for regulated industries, having led projects in product, equipment, process, and computer software validation.
Clark brings 10 years of experience working in senior level Program/Project Management positions, leading projects through the phases of the software development life cycle process at various client locations within the life sciences industry.
We woud also like to announce that we have recently hired Scott Hartman as a Sales and Marketing Account Manager. At Safis, Scott works directly with the Director of Sales and Marketing, Diana Caldwell, to help drive the future growth of Safis Solutions through the development of strong relationships with the growing national and international Life Science sector.
In addition to his sales and marketing experience, Scott also brings more than eight years of experience as an Analytical Chemist and Consultant in the Life Sciences Industry. Within these roles, he has managed a number of projects, ranging from product development to product release. His most recent experiences have included working with dozens of organizations within the Life Science industry to manage the compliance requirements for analytical and process instrumentation.
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2008 Fourth Quarter Events
October
October 26-29; President and CEO Ping Poulsen spoke in Melbourne, Australia, at this year's AusBiotech 2008 Conference. Poulsen shared her expert insight on medical device regulations in her session entitled, "Reimbursement and Regulation for Medical Technology." See Website.
In addition to speaking at the AusBiotech 2008 Conference, Poulsen shared her knowledge on entrepreneurship and the commercialization of biotechnology to an audience of PhD and MBA students from the University of New South Wales in Sydney, and from Monash University in Melbourne.
October 26-29; ISPE held its annual conference in Boca Raton, Florida. Networking activities, exhibits, and special events allow for one-on-one time with colleagues for further knowledge and best practice sharing. See Website.
October 30; The Indianapolis Section of ASQ will held its monthly Bio Medical Division Midwest Discussion Group meeting on the topic of "How many pieces to measure." For more information contact Scott Willis at swillis@productaction.com.
November
November 4-6; Orthopedic Design and Technology will hold its Third Annual Conference and Expo in Fort Wayne, IN, to discuss the latest trends and collaborations impacting the medical device community. See Website.
November 12-13; Medical Products Symposuim in Waltam, MA. Maximizing the Outsourcing Experience: Efficient & Effective Practices for Medical Device Manufacturers. See Website.
November 13; The Business/Bioscience (Biz/Bio) forums were established to inform and educate civic and government leaders about the rewards and consequences of their actions in establishing and maintaining a successful bioscience cluster. See Website.
November 14; Indiana University's Kelley School of Business, Center for the Business of Life Sciences will hold a conference entitled "Intellectual Property" at the Cook Medical world headquarters in Bloomington, IN. See Website.
December
December 3-5; PDA will hold the PDA/FDA Pharmaceuical Supply Chaon Conference in San Diego, CA to discuss guidance, regulations, and Good Distribution Practices (GDP). See Website.
December 10; Life Science Alley will hold its Seventh Annual Conference and Expo in Minneapolis, MN, to discuss the latest trends and collaborations impacting the life sciences industry. See Website. |
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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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Lisa Schuster, RAC, joined Safis Solutions in early 2006, and serves as a Compliance Advisor. She is an experienced auditor, quality specialist, validation engineer, and CMC regulatory specialist. Schuster has developed and implemented quality systems for multiple companies. She also has experience in auditing clinical trial service providers' systems, with special expertise in 21 CFR Part 11 compliance. She is RAC certified, and received her B.S. in Chemical Engineering from Case Western Reserve University.
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Case Study
A laboratory was working with a pharmaceutical company to provide clinical trial sample analysis services.
See the Full Case Study
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Did You Know?
This year, Safis Solutions has done business on all of the continents except Antartica.
Contact us to see how we can help you meet your global regulatory needs.
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