January 2013

For Pharmaceutical Companies

Featured Articles

Richard Vincins

Transitioning from an FMEA Risk Analysis to a Total Risk Management System

by Richard Vincins
Vice President, Quality Assurance Consulting, Emergo Group

Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk assessment is just a part of the entire picture. Organizations are realizing that a total risk management system must be implemented for their quality system to gain the full advantage. This article will discuss how companies can integrate risk management philosophies and techniques into their quality system processes.

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Craig Gygi

MasterControl Revs Operational Excellence Using Six Sigma

by Craig Gygi
Executive Vice President Operations, MasterControl, Inc.

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

Lean-with its recent Far East heritage-embodies the operational, cultural, and leadership philosophies which center all work on increasing customer value while reducing waste. It employs practices that purposely bring process waste to the surface, so it can be actively identified and eliminated by everyone in the organization.

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Sidney Kahn

Highlights of the 2012 Revised EU Pharmacovigilance Regulations

by Sidney N. Kahn
Pharmacovigilance & Risk Management, Inc.

In December 2010, the European Commission (EC) published legislation for implementation in July 2012 that made the most sweeping changes to European pharmacovigilance since 1995. Directive 2001/83/EC, covering non-centrally approved products, was amended by 2010/84/EU, and Regulation EC/726/2004, governing centrally approved products and European Medicines Agency activities, was amended by 1235/2010.

The new regulations replace Volume 9A with sixteen Good Pharmacovigilance Practice (GVP) guideline modules and five Annexes to be adopted in stages, with some provisions of Volume 9A temporarily remaining in effect; details can be found at http://bit.ly/OWQ8AM.

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Cindy Fazzi

Quality Professionals: How to Increase Your Job Security

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

Paula Rutledge, president and founder of Legacy MEDSearch, a recruitment firm exclusively serving the medical device and healthcare industry, noted the overall unemployment rate in the United States (7.9 percent in November 2012 versus 8.9 percent the previous year) and was generally upbeat about the job picture.

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