Free Download: 2010 FDA Warning Letter Data _________________________________________________________
The FDA recently released its medical device quality system data for 2010. According to the agency, 89 Warning Letters were issued to medical device firms for QS/GMP deficiencies, with CAPA being the most prevelant subsystem noted.
This slideshow offers a great overview of which CFR parts and subsystems require the most attention for medical device firms in 2011 and beyond.
Download the presentation. |
Build a Better Process and They Will Come: ISO 9001 Proven to Help Business
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According to data from The British Assessment Bureau's (BAB) independent 2011 Client Satisfaction Survey, 44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001, the quality management system standard from the International Organization for Standardization (ISO).
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New FDA Guidance Aims to Tackle Device Safety and Usability _________________________________________________________
Intended to improve the usability of medical devices, as well as reduce errors, injuries and product recalls, the FDA issued a draft guidance June 22 for conducting tests to see how humans interact with technology.
Referred to in the document as human factors engineering (HFE) and usability engineering (UE), the draft sets a recommended framework to improve the device user interface, according to the agency, so that errors are either eliminated or reduced.
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Can your quality system hold up to regulatory scrutiny?
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Last year alone, nearly 200 Warning Letters were issued to pharmaceutical and medical device firms for quality system deficiencies. Now, more than ever, FDA regulated companies need to focus on quality system improvement.
Our CAPA and Auditing workshops are designed to meet the requirements mandated by the FDA to effectively investigate and locate causes and correct them.
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Medical Device Companies Slow to Adopt Social Media Practices
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The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. In some areas, however, medical device companies lag behind other sectors of the American economy, in particular, the number of companies that have adopted a social media strategy.
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FDA Releases Results of Initial 510K Audit
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The FDA's inital review of rejected applications deemed "Not Substantially Equivalent" found that nearly 80 percent of the rejections cited insufficient performance data, sometimes despite repeated FDA requests.
NSE determinations made up 3.5 percent of decisions on 510(k) applications between 2001 and 20010, and rose sharply to 8 percent in 2010. The rate decreased to 5 percent for the first eight months of fiscal year 2011.
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Survey: Lean Manufacturing Results Receive Mixed Reviews
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Lean Manufacturing, or simply "Lean," is a production practice that aims to eliminate the expense of resources used for any other purpose than to create value for the end customer. "Value" in these terms is defined as any action or process that a customer would be willing to pay for.
Last month we issued a survey asking "Has your company implemented lean manufacturing with success?"
The responses we received were varied, with only 50% of respondents believing the production practice to improve business operations.
View other solutions. |
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Monthly Newsletter
PathWise, Inc.
June 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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