Whitepaper Download : How to Prepare for an FDA Inspection _________________________________________________________
Audits by third parties don't have to be stressful events. The level of preparation within your organization will make a significant difference in your level of success.
This complimentary whitepaper contains some helpful hints and techniques that will enable your organization to perform smoothly during an FDA inspection.
Download the whitepaper. |
FDA Issues Draft Guidance on Medical Apps
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Last week the FDA announced that it was issuing a Draft Guidance on the Oversight of Medical Applications and seeking public input into the draft. For the most part, the guidance is involved with distinguishing what is or is not going to be considered a medical app.
Read complete article. |
First Stop, Third World: Emerging Markets for MedTech
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For several years now, due to regulatory pressure in the US, device companies have been going outside of the country to study and initially commercialize their products. The geography of choice has long been Europe, with its world-class medical institutions and researchers, direct flights from the US East Coast, infinite fine food and beverage options, and a more predictable, less onerous regulatory framework.
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US Medical Devices Spending Steady, Report Shows
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Medical devices accounted for about 6 percent of the total U.S. health spending in 2009, barely changed from 10 years earlier and slightly higher than two decades ago, according to an industry report.
Read complete article. |
New Regulatory Strategy Aims for Safety of Imports
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The U.S. Food and Drug Administration (FDA) last month unveiled a new strategy to enlist the participation of international regulators and other "nontraditional partners" to help deal with the rising tide of internationally sourced products.
Read complete article. |
The Case for Lean Six Sigma in Pharmaceutical Process Development
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The evolution of the pharmaceutical industry has made product formulation, process development, and life cycle management more critical than ever. Expiring patents and the rise of generics, in addition to increasing drug development costs and regulatory requirements, are forcing pharmaceutical companies to develop products faster, cheaper, and better compared with just a few years ago..
Read complete article. |
FDA to Propose Unique ID Rule for Devices by September _________________________________________________________
A proposed FDA rule requiring a unique identification system for medical devices is scheduled for release this September, according to a Semiannual Regulatory Agenda of the Department of Health and Human Services (HHS).
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Poor Submissions to Blame for Lengthy 510K Review Times? _________________________________________________________
The FDA recently released their internal analysis of increasing decision times, confirming industry's claims that the total times for clearance through the 510(k) process have spiked dramatically in the last five years. Since 2005, the average decision time for a 510(k) submission has increased from 90 days in 05' to 140 days in 2009.
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Poll : Will the FDAs New Device ID System Encourage Better Quality Products?
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To better improve traceability of medical devices, a proposed FDA rule would require the labeling of each device to bear a unique identifier to adequately identify the product through distribution and use.
According to Jay Crowley, senior advisor for patient safety, HHS, the FDA, the Center for Radiologic Health, unique identifiers can improve the visibility of device movement, recalls, post-market surveillance, adverse-event reporting and anti-counterfeiting, as well as facilitate data transfer across IT systems.
Do you think the new rule will encourage better quality of medical devices?
Take the poll! |
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Monthly Newsletter
PathWise, Inc.
July 2011 |
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Upcoming Events
CAPA for Life Sciences
These 2-day courses are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
Aug. 3-4, 2011
Boston, MA
Sept. 14-15, 2011
Chicago, IL
Oct.19-20, 2011
Atlanta, GA
Oct.12-13, 2011
Newport Beach, CA
For more information or to register.
_________________ Audit Management
This 2-day course is designed to to train and prepare individuals to manage the quality audit process through reading, lecture, discussion, role playing, and practical exercises.
August 1-2, 2011 Boston, MA
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Documenting Investigations
These one day courses teach proven technical writing techniques and tools that will meet regulatory expectations.
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PathWise Webinars
Integrating FDA and Trending
Requirements into your CAPA System
Best Practices to Manage an FDA Inspection
Conducting OOS and Non-Conformance Investigations
Integrating ISO 14971 and ICH Q9 into the Quality System
Download webinars.
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