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Leadership Insights

The Biggest Story of 2012? Innovation!

Examining the past with an eye on improving the future is something everyone does as a calendar year comes to a close.  This month’s blog will honor that tradition, focusing on the future challenges and the past achievements of our industry. One of the largest challenges our industry faced in 2012 was the economic impact […]

Cost Cutting and Quality

The last several years have been turbulent for the US pharmaceutical market.  Unfavorable economic conditions have hit all sectors of the global economy. Historically, the pharmaceutical industry has been relatively immune to the downswings of the global economic cycle because illness, which provides the opportunities for these pharmaceutical companies to create and produce drugs, never […]

Big Pharma and The Blogosphere: Whose Listening, and What’s Being Said?

If you’re reading this blog, it seems to suggest that you have an interest in user generated content that relates to the Pharmaceutical industry.  If that’s true, you share that interest with me. I blog. I also read, monitor, and track blogs daily and am, in every way, enamored by the blogosphere. Regularly reviewing industry […]

The Biosimilar Guidance Documents; Industry Responds

Regulatory Summary In an effort to incentivize the market place to introduce competitively priced biologics, the Biologics Price Competition and Innovation Act, passed by the Senate in 2009, was signed into Federal Law as part of the Patient Protection and Affordable Health Care Act by President Obama in 2010.  Among other components the BPCI Act: […]

Quality Control: Overhead or Profit Center?

I have recently joined Coda’s team of Quality System bloggers.  My professional background is rooted in the development and management of Quality Control Laboratories.  The experience working to create, export, streamline, maintain, improve, and manage QC labs has not only been enjoyable, but has also given rise to many valuable insights and lessons.  With that […]

Change Management and Change Leadership: A Critical (and Neglected) Relationship

We have previously published blogs that speak to leadership and management interests, exploring topics such as:  THE SUSTAINABLE VALUE OF LEAN TECHNIQUES – 07 June 2011 METHODS FOR CALCULATING AND REDUCING THE TOTAL COST OF QUALITY – 25 July 2011 GLOBAL DEPLOYMENT OF QUALITY SYSTEMS – 24 February 2011 This blog seeks to supplement the […]

The USFDA Launches Initiative to Reduce Infusion Pump Safety Risks

The U.S. Food and Drug Administration has announced a new initiative to address what FDA’s Center for Devices and Radiological Health (CDRH) has referred to as “rampant” safety issues associated with the technology utilized by external infusion pumps. CDRH Director Jeffrey Shuren has called this a first for the agency, exercising its authority over an […]

Warning Letters: Roadmap to Corrective Action

Facilities should understand the importance of this “early-warning” message from FDA. Following an unsatisfactory facility inspection, the FDA has the ability to give individuals and firms an opportunity to take voluntary and prompt corrective action in response to deficient findings before it initiates an enforcement action. FDA uses the Warning Letter to achieve voluntary compliance […]

FDA’s Approach to Globalization

On Feb 4, 2010, Dr. Margaret Hamburg explained in detail the enormous problem facing the FDA. Globalization has made the task of monitoring imports and suppliers daunting and nearly impossible. The huge number of products imported, the vast number of foreign companies that create regulated products, and the increased complexity of the supply chain from […]

Enforcement Actions Rising

Recently, expanding global markets and increased volume of products has increased the real and present threat to consumers, as can be seen by recent public health issues; • lead based paint used by Chinese toy manufacturers, • deadly excipients in veterinary food products, • salmonella outbreaks in spinach and peanut products, and • Heparin contamination. […]