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Is it ever a good idea to write a CAPA against my CAPA system? _________________________________________________________
A common question in quality system management is whether or not to write a CAPA against your CAPA system. The answer- in a nutshell- is maybe. It is appropriate to write a CAPA against your CAPA system if one of the following is present:
· A weakness, or opportunity for improvement, is noted in the system that is not an immediate compliance issue that could be investigated as a PA (preventive action).
· Execution of the process is not consistently followed (or understood) by users. Open a CAPA against training to investigate improving materials or delivery methods.
· Timeliness of CAPA actions are not within acceptable limits. Open a CAPA against execution of a fundamentally compliant system. For example, a negative trend has been detected for how long CAPAs are taking to close that is not attributable to complexity of the investigations or solutions.
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When does a smart phone become a Medical Device? _________________________________________________________
Part of the transformation of health care is the new technology that allows smartphones to be used for diagnosis and tracking medical concerns.
These mobile apps do everything from monitoring heartbeats to managing glucose levels.
There were more than 7,000 health-related apps for the iPhone in September 2010, according to a MobiHealthNews study. With the popularity of the iPad, these numbers are sure to grow.
Read complete article.
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Medical Device Update Increases Class I Reporting Requirements _________________________________________________________
The FDA is toughening up its rules for reporting malfunctions of low-risk medical devices.
This month, Food & Drug Administration officials issued an update for reporting requirements of so-called "class I" and certain "class II" devices that are not permanently implantable or life supporting or sustaining.
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FDA Clears First Mobile Radiology Diagnostic App. Is Digital Pathology Next?
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When the U.S. Food and Drug Administration (FDA) recently cleared-for the first time-a mobile application (app) for Radiology Diagnostics, it set the scene for similar mobile apps to gain FDA clearance for use in evaluating digital pathology images.
Both pathologists and clinical laboratory managers are likely to be intrigued with how swiftly mobile computing technology can adapted for use with healthcare images.
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FDA allows some reprocessing of single-use medical devices
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The recent advertisement defending Dr. Michael Kaplan -- the Las Vegas Valley urologist whose medical license was suspended for reusing single-use needle guides -- sheds a faint light on a little-known truth: Although a medical device is labeled single-use only, it might have been used before.
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Survey: Quality Budgets Increasing in 2011 _________________________________________________________
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Monthly Newsletter
PathWise, Inc.
March 2011
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Upcoming Events
CAPA Workshops 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.
August 3-4, 2011
Boston, MA
October 12-13, 2011
Newport Beach, CA
For more information or to register.
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Documenting Investigations
These one day courses teach proven technical writing techniques and tools that will meet regulatory expectations.
May 13, 2011
Dublin, Ireland
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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New Training Course! Audit Management _______________________________________________
Understanding how to conduct a thorough quality audit is an essential control measure for any organization. Unfortunately, many organizations do not have the luxury of hiring well-seasoned professional auditors-- they must develop them from within. In Audit Management, we teach you how to thoroughly manage a quality audit, sharing insight into pertinent regulatory requirements, as well as the necessary planning, performance and post-audit remediation techniques.
Learn more.
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Facing an uphill battle?
PathWise is a training and consulting firm that works with medical device, pharmaceutical and biotechnology companies in the areas of quality and compliance. We deliver the methodology and tools to ensure compliant, effective and efficient execution of quality system requirements.
Problem Solving Risk Management Documentation
CAPA Quality Systems Regulation Auditing
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Please visit us online at www.PathWise.com or call 866.580.PATH for more information.
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