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That you can bring your team together in a virtual workspace for collaborative projects? Full Story


Especially for Pharmaceuticals

The FDA has issued a new guidance that addresses the scarcity of information about the safety of prescription drugs after they are approved.
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Especially for Pharmaceuticals


Especially for Medical Devices

Competitive Bidding
CMS recently launched a new competitive bidding program for suppliers of durable medical equipment in order to save money. But the medical device industry has expressed concern about the program’s negative effects.
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“Death by CAPA”
Ten years after the FDA introduced a regulation requiring a formal CAPA system, managing CAPAs remains a major challenge for many manufacturers. Let’s consider a few things that could help you improve your system.
By Ken Peterson
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Especially for Medical Devices



Especially for Blood / Biologics

The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.
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Especially for Blood / Biologics



Do's and Don'ts in Process Mapping for Life Science Companies
By John Gagliardi

The medical device and pharmaceutical industries are built upon process orientation to complete tasks in a uniform and documented fashion. Both industries also depend upon a systematic series of linked and reproducible activities completed by trained people to enable inputs to become outputs and outputs to realize a return on investment.

So, how does process mapping help these industries in turning inputs into predictable outputs that would help them comply with regulations, as well as realize commercial success?

Process maps can visually illustrate how work flows, how procedures link together, where greater process efficiency can be realized, and how process participants conduct themselves within the infrastructure of the quality management system (QMS). Visualization is something that employees embrace with far more success than the written word. Process maps not only can make procedures understandable, but it can serve as a training tool to ultimately show your employees and regulatory authorities how your company conducts work.
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21 CFR Part 11: What's New?
By David Ade

The anticipation over a new 21 CFR Part 11 and a new companion guidance for compliance is waning because of persistent speculation within the industry that the FDA is not ready to release the documents until later this year or perhaps next year.

Ever since the agency issued a nonbinding guidance on Part 11's scope and application in 2003, the industry was rife with talk about the need for a better guidance, and perhaps a new and better regulation altogether. Four years later, there is neither a new guidance nor a new regulation in sight. In the meantime, what should life science companies do?

In a recent Institute of Validation Technology conference, several key questions surfaced during various presentations, as well as answers from industry experts and FDA representatives. Here are some of them.

1. Is 21 CFR 11 still being enforced?
In a nutshell: the answer is yes. "Part 11 did not go away," said George R. Smith Jr., a consumer safety officer with the FDA's Center for Drug Evaluation and Research (CDER). He said the "scope and application" guidance issued in 2003 will remain in effect until a new final regulation and companion guidance are promulgated.
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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

43rd DIA Annual Meeting

(June 17-20, 2007)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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Editorial Staff

We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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Editorial Staff

GxP Lifeline
is published once a month by MasterControl Inc.
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Web site: www.mastercontrol.com

Publisher: Curt Porritt
Executive Editor: Jason Clegg
Editor: Cindy Fazzi
Design: Mike Hansen
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