pathwire
 
 
 
 
Complimentary Download : 21 CFR 820 and ISO 13485 Comparison Table
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The FDA and world regulatory bodies have identified that quality systems are essential elements for suppliers, manufacturers and distributions for the design, production and distribution of products. Over the last decade, beyond FDA, additional standards have been developed with include ISO 13485 and ICH Q10 which provide a common frame of reference for a systems-based approach to quality.

 

Learn the key differences between 21 CFR 820 and ISO 13485 in this complimentary comparison table.

 

ISO publishes Six Sigma performance-improvement methodology
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Six Sigma was originally developed by Motorola in 1986 to improve manufacturing processes with the goal to create products free of defects. Today, the methodology is applied in many sectors of activity by organizations large and small.

 

"Although Six Sigma has existed for some time, bringing its best practice together under an ISO standard helps solidify and consolidate the methodology," says Dr. Michèle Boulanger, President of JISC-Statistics and co-chair of the subcommittee that developed the standard.
 
Read complete article.
Study of Medical Device Recalls by FDA Over Last Four Years (2008-2011)
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Medical device recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. According to FDA, "recall is an action taken to address a problem with a medical device that violates FDA law."

 

Recent data from the FDA provides insight into medical device recall trends and how companies can avoid these situations.  

Draft Guidance from FDA to Improve Design of High-Quality Clinical Studies
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Seeking to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices, the FDA has issued a draft guidance. The proposed guidance outlines agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study, and choosing study sites and study participants.
 

"We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market," said Jeffrey Shuren, MD, director of the US Food and Drug Administration's Center for Devices and Radiological Health.

    

Read complete article.
Medical Devices and Health: Creating a New Regulatory Framework for Moderate-Risk Devices
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The recently released Institute of Medicine (IOM) report Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years recommends that the Food and Drug Administration (FDA) begin to develop a new regulatory framework for moderate-risk (class II) medical devices.

  

Read complete article.
FDA Mobile App Draft Document Offers Guidelines - And Raises Questions
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The questions and comments are pouring in over the U.S. Food and Drug Administration's draft guidance on mobile medical apps, making it obvious that the government's first attempt to clarify its regulatory authority over this fast-growing field won't be the last.
    

Read complete article.
FDA Announces Training Program to Improve Medical Device Reviews
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The U.S. Food and Drug Administration (FDA) just announced two training programs it will be implementing that are intended to improve how medical device reviews are conducted.

 

The training will improve review consistency and will help improve the skills of the reviewers looking at premarket applications at the Center for Devices and Radiological Health (CDRH).

    

Read complete article.
Poll : Does your organization employ a full-time quality investigator?   
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Understanding how to conduct a thorough, timely, well-documented and scientifically defensible investigation is a key requirement for any organization operating in a regulated industry.

 

Does your company employ a full-time quality investigator?

 

Take the poll.

Monthly Newsletter 

PathWise, Inc. 

September 2011 

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Upcoming Events

CAPA for Life Sciences 
 
These 2-day courses are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
        
Oct.19-20, 2011
Atlanta, GA

Oct.12-13, 2011
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Audit Management

This 2-day course is designed to to train and prepare individuals to manage the quality audit process through reading, lecture, discussion, role playing, and practical exercises.
 

October 10-11, 2011

 

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Documenting Investigations

 

These one day courses teach proven technical writing techniques and tools that will meet regulatory expectations.

     
December 8, 2011
Washington, DC 
 
For more information or to register. 

 


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PathWise Webinars 

 

Integrating FDA and Trending
Requirements into your CAPA System 

 

This session offers attendees a how-to approach to effectively integrate the FDAs CAPA and trending requirements, providing them with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.
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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.
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Conducting OOS and Non-Conformance Investigations
 

Attendees will learn how to effectively expedite and document OOS and non-conformance investigations to increase compliance in their organizations. 
 

 

Download webinars.

 


 

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handbooks

 

These FDA Inspection Guides provide guidance on the inspectional process used to assess various life science manufacturer's compliance with quality system regulations.

 

 

Biotechnology

  • Biotechnology Inspection Guide

Medical Devices

  • QSIT for Medical Devices
  • Electromagnetic Compatibility Aspects of Medical Device Quality Systems
  • Bioresearch Monitoring Inspections of In Vitro Diagnostics Devices
  • Mammography Quality Standards Act Auditor's Guide
  • Medical Device Manufacturers

Pharmaceuticals

  • Microbiological Pharmaceutical Quality Control Labs
  • Pharmaceutical Quality Control Labs
  • Sterile Drug Substance Manufacturers
  • Dosage Form Drug Manufacturers cGMPs
  • Topical Drug Products

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. 
   
     Change Control               Risk Management                  Documentation           

      CAPA                                 QSR                            Audit Management 

 

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                  Please visit us online at www.PathWise.com or call 866.580.PATH for more information.