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Free Webinar Download: Overview: Quality System Regulation (QSR)

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Make sure you know and understand FDA expectations regarding quality system regulation. 

 

This complimentary webinar provides an overview of the Quality System Regulation and ISO 13485, providing a common frame of reference for individuals at all levels within an organization. 

 
Download complete webinar.

FDA's Role in Fostering the Development of Better Medical Devices

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Infusion pumps rank in the top ten of both the FDA's medical device adverse event list and the medical device recall list. But 87 recalls in the last five years have not produced the next generation of devices. At best, the recalls have led to temporary fixes without addressing the systemic and underlying concerns. Recalls produced patches on top of patches.

To address this and other similar challenges, the FDA is taking a balanced public health approach - to protect and promote public health - by assuring that medical devices on the market are safe and effective while also facilitating innovation.

Management and Leadership: Risk and Quality are two sides of the same coin

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Without a quality system, quality assurance is at best a guess, with no basis for continuous quality improvement.

The first requirement in quality assurance and improvement is the presence of a quality system.  With a quality system in place, quality assurance is possible: and the outcome of quality assurance is continuous quality improvement. 

Read complete article.
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The FDA has made some big changes in the final version of their Frequently Asked Questions (FAQ), Statement of the Investigator (Form FDA 1572) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010).
 
The FAQ states that research coordinators (study coordinators) should "usually be listed in Section #6 of the 1572." This is a significant change from the draft FAQ Information Sheet Guidance that came out in July 2008.
 
Read complete article.
Community Poll: Which Aspect of Your Quality Department Needs the Most Improvement?  
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It goes without saying that a sound quality department can increase organizational efficiencies while avoiding unnecessary costs and product rework. Collaboration and communication are just two of the many essential components to creating a successful quality team. 
 
Which aspect of your quality department needs the most improvement? 
Last Month's Poll Results: Over 30% of CAPAs are Repeats 
 
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Last month, we issued a poll asking "How many of your CAPA Investigations are repeats?"
 
Here are the results from the life science manufacturers worldwide:
 
#1 Over 30%
 
#2 21-20%
 
#3 10-20%
 
 

Monthly Newsletter 

PathWise, Inc. 

June 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.
 
 
 
September 15-16, 2010
Newport Beach, CA
 
 
October 27-28, 2010
San Francisco, CA

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.