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Free White Paper Download: How to Kick-Start your CAPA Process 
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The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. The pressure to put products into the marketplace is undoubtedly intensified by the strict guidelines enforced by the FDA and other regulatory bodies worldwide. Medical device companies are under obligation to meet market demands while complying fully with regulatory requirements.

Over the last couple of years, we have seen a significant increase in warning letters and consent decrees that have in some cases caused a supply chain delay or even plant closure. Every organization understands that an effective corrective and preventive action (CAPA) program is mandatory for doing business while satisfying the FDA guidelines. The bottom line is to find ways to operate effectively within a CAPA system while maintaining profitability.

Download complete white paper.
FDA Changes Advisory Panel Rules for Medical Devices
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The Food & Drug Administration is changing the way its advisory panels deliberate and vote on medical devices under review at the federal watchdog. The Food & Drug Administration is making changes to the way its advisory panels deliberate over and vote on medical devices under review by the federal watchdog agency. 
 
Read complete article.
Supplier Audits Dig Deeper in Recent Years  
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While supplier audits are not new, many companies have conducted more of them in recent years. Sourcing from suppliers in low-cost regions has increased because of last year's economic downturn, which is creating new challenges for organizations looking to maintain product quality.  
 

Read complete article.
Deviations and CAPA most frequent observations in FDA inspections   
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As seen in the Warning Letter Report issued by the European Compliance Academy (ECA) observations in "Production Record Review" (21 CFR 211.192) are among the most frequent GMP deviations cited by the U.S. Food & Drug Administration (FDA).   
 
Read complete article.
Community Poll: Which area of your organization's quality system needs the most improvement?
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Successful businesses place great emphasis on managing their quality system- executing carefully planned steps to ensure that the products and services offered to their customers are consistent, reliable and truly meet their customers' needs.
 
Which area of your organization's quality system needs the most improvement? 
Last Month's Poll Results: Supplier Education and Engagement is Top Priority in Supplier Quality Management 
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Last month, we issued a poll asking "What is the top priority in your Supplier Quality Management plan?"
 
Here are the results from the life science manufacturers worldwide:
 
#1 Engaging Suppliers in Importance of Quality Systems
 
#2 Conducting Supplier Audits
 
#3 Maintaining Supplier Scorecards
 
 

Monthly Newsletter 

PathWise, Inc. 

April 2010 

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Upcoming Events
 
CAPA Workshops for Life Sciences
 
These 2-day courses, taught by former FDA Investigators, PathWise, and MasterControl industry experts, are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
 
May 17-18, 2010
Dublin, Ireland
 
June 16-17, 2010
Boston, MA
 
 
August 18-19, 2010
Tokyo, Japan

PathWise Webinars

 
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. 
  
     Problem Solving                       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.