Whitepaper Download: Risk Management and Assessment of IVD Kits
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In vitro medical devices are the most complex systems available for fool-proof evaluation and validation. System failures activated by design faults can provide lessons for design, development practice, risk assessment and management in quality assurance.
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FDA Stresses Need to Modernize it's Science _________________________________________________________
The Food and Drug Administration must update its scientific tools for reviewing prescription drugs, medical devices and tracking food safety, according to a research plan laid out Wednesday by agency leadership.
FDA Commissioner Margaret Hamburg said the agency will spend $25 million in the coming year on collaborations with outside scientists from academia, government and industry.
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Aiming for Greater Transparency? ______________________________________________________
The FDA has made a big effort at increasing transparency at the agency - creating a Task Force on Transparency, launching a
blog on transparency, putting up metrics that demonstrate the rate at
which goals are being made with FDA Track, and even issuing a Transparency Report back in May. But the area where there is the most interest in transparency, the consideration of approval, may still be lacking.
Read complete article.
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Just Where Does the Buck Stop with cGMPs?
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As most students of U.S. history know, the late President Harry Truman had a sign on his desk, one side of which read "The buck stops here."
If senior management is held directly accountable for cGMP problems, could we see a very different approach to manufacturing?
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FDA may tighten generic-drug rules __________________________________________
FDA may act on anecdotal evidence that some generic drugs don't work as well as their branded counterparts. The agency's CDER chief Janet Woodcock told generics industry folks at a conference that FDA is considering tighter standards for generic drugs.
Read complete article.
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Community Poll: What is the most common reason for Form 483 issuance in CAPA?
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A warning letter has the potential to create disastrous effects for quality management teams and life science companies in general.
In your experience, what is the most common reason for FDA Form 483 issuance in CAPA?
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Monthly Newsletter
PathWise, Inc.
October 2010 |
CAPA Workshops for Life Sciences
This 2-day course, taught by former FDA Investigators, PathWise, and MasterControl industry experts, is designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
October 27-28, 2010
San Francisco, CA
PathWise Webinars
Integrating ISO 14971 and ICH Q9 into the Quality System
This webinar provides insight into the necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.
For more information or to purchase.
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Integrating FDA and Trending Requirements into your CAPA System
This session offers attendees a "how-to" approach to effectively integrate the FDA's CAPA and Trending requirements, providing them with the skills necessary to develop a strong, sustainable and compliant CAPA system.
For more information or to purchase.
Conducting OOS and Non-Conformance Investigations
This webinar provides a process to effectively expedite and document OOS and non-conformance investigations to increase compliance in your organization.
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