Complimentary Article Download: Qualification and Validation of Middleware and Service-Oriented Architectures
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Companies in regulated life science industries must ensure that all computer systems critical to product quality or patient safety are validated. This article, written by industry expert David Stephenson, covers the age old argument, do we Validate, or do we Qualify, and provides not only an answer for SOA and Middleware, but introduces a tried & tested methodology for success.
Download the article. |
In today's competitive global market, it has become increasingly more important for FDA to review how it accomplishes its mission of protecting and promoting public health at a minimum burden to the industry as well as to itself.
One of the better ways of realizing that mission is to ensure that "good" products get into the market as quickly as possible and that "bad" products are kept out of the market. A key means by which FDA achieves this goal is by challenging the adequacy of the quality systems of medical device manufacturers through inspections.
Read the full post. |
Complimentary Webinar Download: The Application of Lean Management Systems in Life Science Industries
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Lean Management Systems provide an incredible value for manufacturing and life science organizations alike. In this complimentary webinar, Hormoz Mogharei provides an indepth look at how the application of LMS can positively impact quality, efficiency and ultimately the bottom line for medical device and pharmaceutical companies.
Download the webinar. |
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 |
Community Poll: What is the Average Length of Your CAPA Projects?
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CAPA Projects are typically allocated a vast amount of organizational resources, and are arguably the most time sensitive project a quality department can endure. Yet despite interference from the FDA, many organizations still struggle to close these projects in the allowed timeframe.
How long does it typically take your organization to close out a CAPA project?
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Last Month's Poll Results: CAPA Item Most Struggled with is "Identification of Root Cause"
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Last month, we issued a poll asking "What is the single item you struggle with most in your CAPA projects?"
Here are the results from the life science manufacturers worldwide:
#1 Identification of Root Cause - 47.4%
#2 Documentation of Investigation - 15.8%
#2 Effectiveness Checking Measures - 15.8%
#3 Problem Statement - 10.5%
#3 Corrective and Preventive Actions - 10.5%
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Monthly Newsletter
PathWise, Inc.
December 2009 |
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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