pathwire
 
 
 
 
Complimentary Article Download: Risk
Assessment and Management in IVD Kits
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In vitro medical devices are the most complex systems currently available for fool-proof evaluation and validation. System failures activated by product design faults can provide lessons for design, development practice, risk assessment and management in quality assurance. 
 
This article will examine the most common issues associated with IVD kits and stresses the importance of risk management and quality system integration. 

Download the article.
Head of FDA's Device Division Steps Down 
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The head of the Food and Drug Administration's medical device division is stepping down, months after staff scientists alleged they were pressured to approve certain products. In a letter to agency staffers, Daniel Schultz says he and FDA Commissioner Margaret Hamburg agreed his resignation "would be in the best interest of the center and the agency."
 
Read the announcement.
Community Poll: How Many of Your Investigations are Repeats?
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Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.
 
How many of your investigations are repeats?

Vote now.
FDA Launches New Program to Facilitate the Timely Issuance of Warning Letters
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The Food and Drug Administration (FDA) is announcing a program to facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of post-inspection responses.  
The program will allow for the issuance of a warning letter even as corrective actions are being implemented within the company.
Medical Device Fee Rates for Fiscal Year 2010
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The FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The base fee will increase about 8.5%, from $200,725 this fiscal year to $217,787 in fiscal 2010, which begins Oct. 1.  
 
Read the announcement.
New Community: Corrective and Preventive Action (CAPA) Group
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PathWise is pleased to offer a resource platform and discussion board for life science professionals! With over 125 members, participants can keep up-to-date with Corrective and Preventive Action and related processes, systems and best practices. Membership is free and
features valuable networking opportunities, as well as the latest news and updates impacting the life science industry.
  
Join Today.

Monthly Newsletter 

PathWise, Inc. 

August 2009 

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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.

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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.

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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. 
 
PathWise is pleased to announce the availability of our latest CFR, ICH and QSIT resource guides. These handy pocket-size booklets are an ideal way to keep your organization informed of the most current FDA regulations and guidelines.
 
Available guides include:
  • 21 CFR 820  - Quality System Regulations
  • 21 CFR 210-211 - Pharmaceutical GMPs
  • 21 CFR 111 - Dietary Supplements
  • 21 CFR 606 - Blood Industry
  • ICH Q9 - Risk Management for Pharmaceuticals
  • ICH Q10 - Quality Systems for Pharmaceuticals
  • QSIT for Medical Devices

Order Online

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                                                                  Facing an uphill battle?   

PathWise is a training and consulting firm that works with medical device, pharmaceutical and biotechnology companies in the areas of quality and compliance. We deliver the methodology and tools to ensure compliant, effective and efficient execution of quality system requirements. 
  
Root Cause Analysis                       Risk Management                              Documentation

                      CAPA                                              Quality Systems Regulation               Auditing 
 
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                  Please visit us online at www.PathWise.com or call 866.580.PATH for more information.