pathwire
 
 
 
 
Free Download: FDA Design Control Presentation  _________________________________________________________     

  

The FDA requires that medical device manufacturers establish and maintain procedures to control the design of their devices. 

 

This complimentary presentation offers guidance to companies looking to improve control over the design of their products, processes and changes to existing designs and processes to meet regulatory expectations.

                                

 

Download the presentation.
For Health IT Firms, Regulatory Questions Abound
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"By providing predictable, flexible and sensible oversight of certain mobile medical technologies, FDA hopes to promote innovation, while protecting public health," an agency spokeswoman recently said.

 

From smartphone applications that count calories to for-medical-use-only products, such devices have complexity and expectations that vary wildly. Where do regulators draw the line?

    

House Panel Proposes Big Cuts to FDA Budget
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The Food and Drug Administration would take an 11.5 percent budget cut under a spending bill that House appropriators released Monday.

The Appropriations Committee released its 2012 spending bill for the FDA and the Agriculture Department ahead of a subcommittee vote scheduled for Tuesday. The FDA would lose roughly $285 million.

    

An Overview of Quality Audit Management 

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Understanding how to conduct a thorough quality audit is an essential control measure for any organization. Unfortunately, many organizations do not have the luxury of hiring well-seasoned professional auditors-- they must develop them from within.

 

In this one hour session, we'll teach you the basics of how to manage a quality audit, sharing insight into pertinent regulatory requirements, as well as the necessary planning and performance techniques.

   

Do Traditional FDA "Silos" Discourage Combination Product Development?   _________________________________________________________     

There exists both promise and roadblocks for combination drug/medical device/biologic products, which present unique packaging challenges.

 

In a nutshell, FDA law depends on the product. The best first step in any analysis is to establish what type of product you are dealing with.


Despite Recalls, Medical Device Industry Presses FDA to Speed Up Approval Process
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Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process.

 

That pressure comes as a new Government Accountability Office report criticized the way the FDA has handled approval of high-risk devices. 

Survey: Has Your Company Implemented Lean Manufacturing with Success?
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Lean Manufacturing, or simply "Lean," is a production practice that aims to eliminate the expense of resources used for any other purpose than to create value for the end customer. "Value" in these terms is defined as any action or process that a customer would be willing to pay for.

 

Has your company implemented lean manufacturing with success?  Please share with us!

 

Take our poll.  

Monthly Newsletter 

PathWise, Inc. 

May 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.
      
August 3-4, 2011
Boston, MA
 
October 12-13, 2011
Newport Beach, CA
 
For more information or to register.
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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.

 

August 1-2, 2011

Boston, MA
 
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 

Best Practices to Manage an FDA Inspection

Conducting OOS and Non-Conformance Investigations

Integrating ISO 14971 and ICH Q9 into the Quality System 

 

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. 
  
     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.