So Now That the Food Safety Bill Has Passed, What’s Next?

So Now That the Food Safety Bill Has Passed, What’s Next?

On January 5, 2011, the Food Safety Modernization Act was passed into law by President Obama.  The new legislation gives the Food and Drug Administration the power to recall tainted food, quarantine geographical areas and access food producers’ records. According to the FDA, the burden of foodborne illness is considerable.  Every year, 1 out of 6 people in the United States — 48 million people — suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die. So what does the new legislation mean to food processing companies and manufacturers now? (more…)

The New Year is a Good Time to Think About Audits

The New Year is a Good Time to Think About Audits

From December 26th on, you can’t help but see articles on the best and worst of 2010. We had Toyota, BP and eggs topping the news, and it didn’t shed much of a positive light on quality management. So as the new year kicks in, perhaps it’s time to examine your own products and processes in order to ensure compliance with organizational and industry regulations. (more…)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

Guidelines for governance, risk and compliance (GRC) affect nearly every company in every industry today, with different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable.  To achieve this, a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance must be established. (more…)

Five Key Essentials for a Good Electronic Document Management System

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

FDA tells Drug Makers, “Just the Facts, Ma’am”

FDA tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
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Risk Management: An Opportunity or a Challenge?

Risk Management: An Opportunity or a Challenge?

All organizations at some point face issues in their operational activities related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk. A series of highly publicized blunders, from BP’s oil disaster and Toyota’s massive recalls, to the egg recall, along with regulatory mandates and more active involvement among shareholders, are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. (more…)

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes. (more…)

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that at least 13 people may have died because of the problem. It’s situations such as this that emphasizes why standards have been put in place, such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk. (more…)

MHRA Looking for Quality Risk Management Systems — Sound Familiar?

The UK is on to something. British inspectors will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments when inspecting drug manufacturers. It seems both sides of the Atlantic are on board with quality risk management, and for good reason. (more…)

Get Lean! Using Six Sigma and Lean Strategies to Improve Quality

The goal of lean is to eliminate waste and non-value-added steps at all points in the manufacturing process. To accomplish this, lean implements continuous improvement practices and eliminating waste across the enterprise. Technology has been successful as key to achieving this end. While saving money might be an initial consideration with lean strategies, customer satisfaction is of utmost importance to any organization. By concentrating on customer satisfaction and value while eliminating waste, a company can build profits as well. (more…)