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Newly Published FDA Guidance for Industry-cGMP Phase 1 Investigational Drugs. Is your business plan affected?
As you may have read in the recently published "Guidance for Industry - cGMP for Phase 1 Investigational Drugs", the FDA now exempts phase 1 clinical investigational and exploratory products, from complying with 21CFR 211. 21CFR 211 regulations are directed for large scale commercial product manufacture, which may not be appropriate for clinical materials. Scientifically sound cGMPs, emphasizing patient safety, still need to be applied when manufacturing phase 1 clinical trial products, complying with § 501(a)(2)(B) of the FD&C Act. This new guidance provides approaches for complying with § 501(a)(2)(B) of the FD&C Act. View full article. |
FDA's Revised Outlook will Increase the Supervision of Diagnostics Products.
Are your products compliant?
The Federal Food, Drug, & Cosmetic (FD&C) Act gives the FDA authority to regulate medical devices, characterized, in short, as an "in vitro reagent or other related article, including any component, part, or accessory that is intended for use in the diagnosis of disease."
Challenges in the regulation of diagnostic products are increased by recent advances in technology-particularly in the biotechnology and genetic testing fields. Recent FDA proceedings indicate that, barring congressional or judicial intervention, FDA intends to notably tighten its regulatory control of analyte specific reagents (ASRs) and in vitro diagnostic multivariate index assays (IVDMIAs). These groups include many genetic-based tests and other unconventional diagnostic products and technologies that have previously been unregulated, or minimally regulated, by FDA. This article discusses recent developments in FDA's regulation of such products in the context of the FD&C Act's overall regulatory scheme for medical devices. View full article.
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Safis Welcomes John Lockwood as a Senior Compliance Advisor
As a consulting company, we know the importance of hiring the best talent. Therefore, we recently hired John Lockwood as a Senior Compliance Advisor.
Lockwood, CQA, brings 14 years of experience in the Medical Device industry to Safis. Prior to joining Safis, Lockwood worked for Roche Diagnostics for seven years serving in a breadth of roles including Quality Control manager, Test Method Validation manager, Supplier Quality Engineer, and Purchasing manager. In addition, he worked for Abbott Laboratories for seven years in various technical support and product development roles.
Lockwood specializes in quality management systems, design control methodologies, supply chain assessments, device and diagnostic product development planning, and quality compliance. His certifications include Six Sigma Green Belt, C.P.M., and CQA. Lockwood obtained a Bachelor's degree in chemistry from the University of Illinois. |
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2008 Third Quarter Events
September
September 4, President and CEO, Ping Poulsen has been invited to speak on "Career Development" at the Lilly Chinese Culture Network Seminar. The Lilly CCN consists of nearly 500 Chinese employees. See Website.
September 8-12, PDA/FDA Joint Regulatory Conference will be held in Washington, D.C. The event's focus is harmonizing requirements and implementing new systems for assuring and maintaining pharmaceutical quality. See Website.
September 14-17, The RAPS Annual Conference & Exhibition will be held in Boston, MA. Senior Compliance Advisor, John Steichen will share his expert insight on medical device compliance in a roundtable discussion entitled, "RAC Exam Last-Minute Study and Effective Preparation." See Website.
September 16-17, the ISPE Great Lakes Chapter will hold a vendor show and education program in Indianapolis, Indiana. See Website.
September 20, the 2008 Indianapolis Start! Heartwalk for the American Heart Association. See Website.
September 26, Director of Regulatory Affairs and Quality Compliance, Gretchen Bowker will speak on "Global Regulatory for Life Sciences" at the Indiana Life Sciences Collaboration Conference Series presented by Indiana University's Kelley School of Business. See Website.
September 26-29, President and CEO, Ping Poulsen will speak to 500 entrepreneurs from all over the world at the Chinese Entrepeneurs Summit. The event will be held in the Great Hall of the People in Beijing. See Website.
October
October 26-29, President and CEO, Ping Poulsen was invited to speak in Melbourne, Australia at this year's AusBiotech 2008 Conference. Poulsen will share her expert insight on medical device regulations in her session entitled, "Reimbursement and Regulation for Medical Technology." Don't miss the premier biotechnology conference for the Asia Pacific region. See Website.
In addition to speaking at the AusBiotech 2008 Conference, Poulsen will share 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 will hold 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.
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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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Case Study
Our client: A large diagnostics company engaged Safis to provide validation and documentation services. See Full case study.
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Ryan White joined the Safis team in 2006 and serves as a Senior Compliance Analyst. Prior to joining Safis, White worked as Manager of Regulatory Affairs and Quality Assurance for 3 years for a Medical Device Company. While there, he worked in a variety of roles overseeing product development, FDA submissions, quality, and manufacturing. He also has experience assisting medical device, in-vitro diagnostic, pharmaceutical and biopharmaceutical clients with the establishment of Quality Systems and the creation and filing of Regulatory documentation. He has successfully audited dozens of GMP, GLP, and GCP facilities on behalf of clients. White is a graduate from Indiana University.
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Please Join Us!
Join us in the 2008 Indianapolis Start! Heart Walk for the American Heart Association. The walk will convene at the White River State Park on September 20, 2008 at 8am. Click here to join our team.
For more information on this event visit the American Heart Associations website at AmericanHeart.org
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