The Global Harmonization Task Force has recently proposed a new guidance on CAPA, which recommends a phased CAPA system.
The Association for the Advancement of Medical Instrumentation (AAMI), Nathan Conover and Vera Buffaloe are currently offering a webinar to discuss the impact this new guidance will have on medical device organizations and will offer recommendations for its implementation.
Read the proposed guidance.
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Complimentary Article Download: The 5 "W"s of Quality Agreements
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A Quality Agreement is a document that defines both specific quality parameters for a project AND which party is responsible for the execution of those parameters. The level of detail in these agreements may vary depending on the developmental stage of the project. To fully understand the dynamics needed to produce a strong quality agreement, it is necessary to first examine the 5 "W"s that go into it.
This article, written by industry expert Arvilla Trag, covers the What, Why, Where, When and Whos of quality agreements and offers best practices for quality improvement.
Download the article. |
Did You Know? The FDA Issued 73 Warning Letters for Dietary Supplements in 2009
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The 73 Warning letters issued in 2009 compare to only 44 issued in 2008 - a 66 percent increase. When new leadership came to FDA in 2009, they came with a promise to step-up enforcement compared to the previous administration, and so far they have delivered on that promise.
Read the full report. |
Community Poll: What tools do you find most useful when managing risk?
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Effective Risk Management is a critical initiative for those under increased regulatory scrutiny. In the past decade, ISO 14971 and ICH Q9 have been recognized by the FDA as the standards to which all life science organizations should comply. Now, more than ever, companies need a strong risk system in place and the right resources to allow them to make the right decisons.
What tools do you find most useful when managing risk?
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Last Month's Poll Results: On Average, CAPA Projects Take 6-12 Months to Close Out
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Last month, we issued a poll asking "What is the average length of your CAPA projects?"
Here are the results from the life science manufacturers worldwide:
#1 6-12 months - 42.9%
#2 3-6 months - 28.6%
#2 2-3 months - 28.6%
#3 Over 12 months - 14.3%
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Former FDA Investigator to join PathWise and MasterControl, Offering Intensive CAPA Training in Washington DC
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This March, former FDA investigator Dannie Rowland, as well as representatives from PathWise and MasterControl will offer a 2-day, intensive CAPA workshop in Leesburg, VA. The event, to be held at K2M, will cover such areas as Issue Review, Root Cause Analysis, Vertification and Effectiveness Checking.
View the workshop agenda | |
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Monthly Newsletter
PathWise, Inc.
January 2010 |
CAPA Workshop for Life Sciences
March 3-4, 2010
Washington DC
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.
For more information or to register.
PathWise Webinars
Best Practices
to Manage an FDA Inspection
When it comes to quality system audits, the level of preparation within your organization can make a significant difference in your level of success. This webinar discusses how to effectively prepare for and manage an FDA inspection.
For more information or to purchase.
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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