New CAPA/Risk-Supplier Warning Letter From FDA
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The FDA has recently issued a new Warning Letter which identified internal CAPA issues which included separate citations for supplier problems and risk management issues in connection with the CAPA issues.
The FDA has been emphasizing the manufacturer's responsibilities for supplier issues, and this is but further indication of this responsibility of the manufacturer. According to industry expert Ed Bills, we shall continue to see these citations of warning letters, product seizures, injunctions and clinical investigator disqualifications going forward.
Read the full post. |
FDA Selects Quality Management System Software Solution from MasterControl and i4DM
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After an extensive evaluation of industry solution providers, the FDA's Office of Regulatory Affairs (ORA) selected MasterControl's quality management software solution to be used by their agencies that are engaged in field investigations enforcement, and scientific laboratory analysis of field samples. The system will be implemented across the United States, in regional offices, district offices, laboratories, and headquarters.
Read the press release.
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PathWise and MasterControl Offer Intensive CAPA Training in Orange County
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Earlier this month, representatives from PathWise and MasterControl presented a 2-day, intensive CAPA workshop in Newport Beach, CA. The event, held at the Bayview Marriott drew over 20 participants from more than 10 life science organizations, including Abbott Vascular, McKesson, Victus, Biomed and Meridian Life Science.
Read the press release. |
Complimentary Article Download: Creating an Organization-Wide Continuous Improvement Culture
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Want to improve your business situation? Regardless of the reasons why, a recognized need to improve the performance of your business is all that is needed to get the ball rolling. Once the decision is made, however, several questions immediately come to mind. Which approach? How do we start? How many people will this take? What do I expect to get from this? You can chose Six Sigma, Lean, Baldrige, ISO, PDCA, or any of the latest continuous improvement methods. With the right tools, attitude and commitment, any of these approaches can be successful.
This article, written by industry expert Jim Wells, will address the importance of creating an organization-wide continuous improvement culture and provide best practices for success.
Download the article. |
Community Poll: What is the Single Item You Struggle with Most in your CAPA Projects?
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From the problem statement to root cause identification, corrective and preventive actions to effectiveness checking measures, many hours of preparation are needed to compile a strong CAPA project.
In your experience, what is the single item most companies forget to include in their CAPA report?
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Last Month's Poll Results: Most Companies Would Rate their Effectiveness Checking "Moderate" at Best
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Last month, we issued a poll asking "How Would You Rate the Effectiveness Checking within Your CAPA System?"
Here are the results from the life science manufacturers worldwide:
#1 Moderately Effective - 58%
#2 Not Effective - 18%
#3 We do not have a process for Effectiveness Checking - 12%
#4 Highly Effective - 6%
#5 What is Effectiveness Checking? - 6%
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Monthly Newsletter
PathWise, Inc.
November 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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