Colleen Nugent | Sparta Systems
The ability to manage product quality is a critical part of the supply chain process, especially in the prevention of recalls, or worse, to manage a recall effectively. For example, Pharmaceutical companies typically require ingredients from many different suppliers and partners to produce a single product. These suppliers have their suppliers, many of which are globally dispersed. As the supply chain grows more complex, the attention given to supervision and quality can be compromised.
To gain control over the quality processes of an entire supply chain and more accurately evaluate supplier performance, leading pharmaceutical manufacturers are turning to enterprise quality management solutions (EQMS). EQMS helps provide manufacturers with a clear view of the entire manufacturing process and supply/value chain to stakeholders. An investment in a quality management system can help manufactures with insight into work flows, triggering warnings early on in the process. By connecting designers, suppliers, and manufacturers, it provides greater traceability and accountability. EQMS keep suppliers in the loop and notifies them of changes sooner, rather than later, which improves product quality and reduces operational costs all while increasing efficiency, product reliability and safety.
Continue reading “Building Quality Management into Your Supply Chain Strategy”
In the pharmaceutical industry, mergers and acquisitions happen on a fairly frequent basis and as such, require due diligence across various business processes. While these mergers may have positive and negative effects on the industry as a whole, one of the most pressing issues is whether the compliance risk is raised as a result.
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In The Headlines
October 22, 2014
Lisa E. Davis | Quarles & Brady
Lisa E. Davis | Quarles & Brady
The past three years have been tough on America’s drug industry. The entire chain of commerce from Manufacturer to wholesaler to pharmacy continues to defend accusations that their business dealings caused the federal and state governments to pay “false” claims at taxpayer expense. Through a seemingly orchestrated campaign, the US Attorney General, the Office of Inspector General for HHS, and various state Attorneys General all tout the ongoing need for persons with knowledge of industry practices to “blow the whistle” on their employers. This campaign is impacting all levels of the drug industry and targeting an array of conduct.
Continue reading "They Ain’t Just Whistling Dixie: The Latest on Whistleblowing in America’s Drug Industry"
Topic of Discussion
The enactment of the Dodd–Frank Act was intended to provide the SEC with an important weapon in its mission to seek and vigorously prosecute the commission of securities and other types of frauds domestically and overseas. By providing to whistleblowers monetary incentives ranging between 10 percent and 30 percent of fines assessed, the whistleblower program has gained an element of popularity—some would say notoriety—amongst would-be reporters of putative wrongdoing. Recent Federal Court decisions, however, have created significant roadblocks that could blunt the Dodd–Frank juggernaut.
Continue reading "Recent Trends in Whistleblower Protection under Dodd–Frank"