That you can bring your team together in a virtual workspace for collaborative projects? Full Story
The FDA has issued a new guidance that addresses the scarcity of information about the safety of prescription drugs after they are approved.
Especially for Pharmaceuticals
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.
“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
Especially for Medical Devices
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.
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.
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.