Based on recent reviews of device submissions, the FDA has expressed concern that most labeling is ineffective and unusable by the intended user--professional or lay--and may be a source of use errors leading to adverse events. Ineffective labeling produces economic consequences that can: 1) negatively impact clinical studies, 2) hinder FDA approval, 3) delay launch dates, 4) spike costly customer support calls and in worse cases, 5) provoke liability claims. This webinar will examine the most common problems associated with medical device labeling and identify six steps, based on human factors engineering principles, that will help med device companies to achieve better labeling with a higher return on investment. Download the webinar. |
Improving ROI of Six Sigma With Root Cause Analysis
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Do you hear Six Sigma professionals express frustration that the organization does not support their efforts? Are there department heads in your life who have complained that their Six Sigma professionals are not delivering the needed results? And that each project is too time-consuming?
The key to continuous improvement may lie within root cause analysis. In this article, Tracy Willis walks you through a PathWise recommended, 4-step process for evidence-based root cause analysis.
Read the complete article. |
House Approves $2.99 Billion FDA Budget
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This month, the House overwhelmingly approved a $373 million budget increase for the Food and Drug Administration, the largest boost in the agency's history. The House voted 266 to 160 to give the FDA a $2.99 billion budget for fiscal year 2010.
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Reader Poll: Will Your Company be Affected by the new Health Reform Act?
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On November 5-6, 2009, PathWise will be partnering with local associations and regulatory bodies to offer a 2-day, intensive CAPA workshop. The event, to be held in Newport Beach, will offer a closed-loop approach, examining specific areas such as Issue Review, Root Cause Analysis, Implementation and Effectiveness Checking to help improve attendee problem solving skills and eliminate the cause of repeat investigations.
View event details. | |
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Monthly Newsletter
PathWise, Inc.
July 2009 |
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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