Complimentary Article Download: The Commonalities Between Risk Management, Verification and Validation
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The device is finally designed- now, you just have to get through the Design Verification and Design Validation process before you put the device on the market. What is necessary to get through these steps?
The FDA has a requirement in Design Outputs (21 CFR 820.30 d) to "ensure that those design outputs that are essential for the proper functioning of the device are identified." This article, written by industry expert Ed Bills, will address the challenges in risk management design vertification and validation, providing best practices for success. Download the article. |
Community Poll: How Would You Rate the Effectiveness Checking in your CAPA Investigations?__________________________________________________
Effectiveness Checking is a key element of a well-structured CAPA investigation, and when missing, is often a reason for the abundance of unresolved and/or repeat CAPAs.
How Would You Rate the Effectiveness Checking in your CAPA Investigations?
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FDA Claims 'Sloppy' NDAs, GMPs May Be Signal of Systemic Problems
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Sloppy new drug applications (NDAs) or good manufacturing practices (GMPs) may be considered red flags by the FDA, prompting regulators to take a closer look at other company processes, says Deborah Autor, director of CDER's Office of Compliance. The FDA's new enforcement initiative will boost the number of warning letters, product seizures, injunctions and clinical investigator disqualifications going forward, and the speed of enforcement actions also is likely to increase, Autor added.
Read the full article. |
Facility Registration, Import Problems Keep CDRH Compliance Office Busy __________________________________________________
CDRH Compliance Director Tim Ulatowski gave an update last week on activities at his office, including import safety efforts and a notable warning letter push.
Speaking at the Food and Drug Law Institute Enforcement and Litigation Conference in Washington, D.C., Oct. 13, Ulatowski said the environment at FDA is shifting to faster and more aggressive action to address regulatory problems.
Read the full article. |
Last Month's Poll Results: Many Companies Not Trained Adequately on How to Conduct RCA
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Last month, we issued a poll asking "Why is it difficult to locate the root cause of a CAPA?"
Here are the results from the life science manufacturers worldwide:
#1 Individuals are not trained adequately on how to conduct a root cause analysis - 37%
#2 We have difficulty differentiating between a symptom of the cause and the root cause itself - 32%
#3 We have limited resources to investigate them - 21%
#4 Investigators or management make rash decisions or "quick fixes" - 10%
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Monthly Newsletter
PathWise, Inc.
October 2009 |
CAPA Workshop for Life Sciences
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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