January 2013

For Blood & Biologics Companies

Featured Articles

Vivian Bringslimark

100% Training Complete ≠ 100% Effectively Trained

by Vivian Bringslimark
President HPIS Consulting, Inc.

Measuring effectiveness of training requires a "performance" assessment. Examples of employees' performance show up in batch records and executed forms every day. In addition, deviations and CAPAs are areas where employees' ability to perform procedures can be evaluated. During a regulatory inspection, investigators will conduct this "paper" performance audit and observe live real-time performance during the "walking" tour of the facilities. Will the regulators conclude 100% effectively trained?

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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 Criag 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.

In a better-late-than-never move, ISO published 13053-1/2:2011, "Quantitative methods in process improvement - Six Sigma - Part 1: DMAIC/Part 2: Tools and techniques." This further confirms Six Sigma and Lean as the standards for global operations.

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David Ade

Remote Audit: Out of Sight but Not Out of Mind

by David Ade
Customer Success and Reference Manager, MasterControl, Inc.

In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognize not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

Fortunately, it is now possible to conduct an audit without being physically present at the facility under audit. The development of web-based systems, video conferencing and desktop share technology allows auditors to see information from virtually anywhere in the world.

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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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Top Five Ways Automation Can Boost Financial Success in the Life Sciences Industries

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