FDA Featured Articles
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How Cloud-Based Tools Can Help With FDA Compliance
8/30/2013
With internet technology being more global, sophisticated, and secure pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive. Cloud-based tools, such as wikis, offer a paradigm shift in project management, FDA compliance requirements, and job aids for mentoring new employees. With centralized systems, validation issue trails can be tracked for QA and FDA auditing purposes.
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Adaptive Funding: Survival Of The Fittest In The Life Sciences Start-Up Evolution
8/29/2013
Art Pappas, founder of Pappas Ventures, talks about how life science start-ups and venture capitalists had a period where excellent investment returns were dampened by poor product performance and regulatory hurdles.
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GDUFA Sheds New Light On Industry’s Common Ground
7/1/2013
FDA user-fee programs will now apply to all the competing pharma sectors — and in many ways highlight the interests they share.
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The Benefits Of Using Integrated Technology With Clinical Trials
7/11/2011
The costs of clinical trial operations are continuously being evaluated for ways of achieving greater efficiency while reducing expenses. Many biopharma companies, now more than ever, focus on containing costs while maintaining quality. By Neil Warnock, M.D.
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WIB Profile - bluebird bio Scientist On 10 Years Of Performing Tech Transfers
Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.
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ISPE Product Manufacturing Quality Metrics Initiative
ISPE commenced its Quality Metrics Initiative in June 2013 after the US Food and Drug Administration (FDA) announced its Quality Metrics Program in a February 2013 Federal Register notice. To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.
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Enable A Data-Driven Quality Culture Throughout Pharma Organizations
Real-time measurement strategies allow identifying process faults and undesired trends during production facilitating preventive/corrective actions to be taken before product quality is compromised.
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Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design
This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka
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How To Keep Compliance With Title 21 CFR Part 11 And EU GMP Annex 11
This white paper analyses the requirements of Part 11 and Annex 11 as they apply to environmental monitoring and validation, and outlines how Vaisala’s Continuous Monitoring System software viewLinc helps firms meet the requirements of both.
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The Road To Compliance: Serialization Standardization Through Open-SCS
As companies around the world implement the necessary changes to comply with serialization policies, it will add an increased level of cost, risk, and especially complexity to today’s operations.