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January - March 2012

Cindy Fazzi

Is FDA to Blame for Biomedical Industry's Slow Growth?

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.

Eight in 10 CEOs of biomedical companies who participated in a recent survey "agreed" or "strongly agreed" that the current FDA approval process has slowed the growth of their organizations. Eighty percent of the surveyed CEOs do not believe that the FDA has the best regulatory process in the world. Three-quarters believe that within five years, another country could conceivably recreate the ecosystem that has made the United States the leading biomedical region in the world. Survey results were released in January.

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Christine Park

Is Your Executive Management Team as Involved with the Quality System as They Should Be?

by Christine Park
Christine Park & Associates

We've all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems.

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Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

by Orlando Lopez
Independent Consultant

Part 11 establishes the requirements for the technical and procedural controls that must be met by the regulated user if the regulated user chooses to maintain regulated records electronically. Part 11 was published in March 1997. It is strictly applicable in the US to all FDA program areas. Part 11 is applicable also to manufacturers outside of the U.S. and its territories who wish to gain US FDA market approval. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. For the purpose of this analysis it is required to consider the Part 11 Guideline (2003). This guidance is the one used by the FDA for interpretation and to enforce the Part 11 requirements established in the Part 11 regulation.

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Stephen F. DeAngelis

End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals

by Stephen F. DeAngelis
Technology and Supply Chain Sector Entrepreneur, Enterra Solutions, LLC

In a survey conducted by ChainLink Research, pollsters found that "the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being shortsighted. Enterprise strategist, Lora Cecere, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that [they need to] sense, shape and respond by listening, testing and learning with minimal latency."

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February 15-16, 2012, Allschwil, Switzerland

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Did you know that U.S. researchers are undergoing a phase I safety study using a child's umbilical cord blood stem cells to try to restore hearing loss? Dr. James Baumgartner, sponsor of the study and guest research collaborator at The University of Texas Health Science Center at Houston Medical School, said the yearlong study will follow 10 children, ages 6 weeks to 18 months, who have sustained post-birth hearing loss.
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