In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online Medical Device Reporting requirements and guidelines.
Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week.
Outsourcing and offshoring continue to be major manufacturing trends today. And, as the amount of external manufacturing grows relative to in-house manufacturing, so do the number of quality events. From 2004 to 2013, FDA drug recalls increased by an unprecedented 600 percent. This surge is especially troubling as global supply chains become more and more complex.
In the wake of another recall of its ice cream products, Blue Bell has stood firm in its belief that a "robust" testing program it implemented following last year's listeria contamination is helping the company create safe treats.
October 13, 2016
Food Engineering Magazine discusses the benefits of automating food quality & safety management.
Sparta’s recent Food Quality & Safety Survey Report is featured by Food Engineering magazine.
Industry Solutions Director, Brandon Henning, discusses his recommended to-do list for food companies needing to comply with the Foreign Supplier Verification Program (FSVP), part of the FDA’s Food Safety Modernization Act.
Sparta’s Brandon Henning discusses the 5 ways to manage supplier quality to ensure FSMA compliance
Medical Design Briefs article on "The Growing Trends in Crowdfunding - Movies, Games...Medical Devices?
Eileen has been featured in the Inc. article "30 Executives Share Their Daily Habits for Success" by Christina DesMarais.
Our own food and beverage expert, Brandon Henning, shares insight on the Blue Bell situation.