The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Medical Device Field Service Performance Inspection Process Validation


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related LinkedIn Groups

ISO 9001 for Small Businesses

ISO 9001:2015 Revision Discussions

Information Security Community

Medical Devices Group

Quality and Regulatory Network

FDA (Food and Drugs)

AS91XX Series - Tips and Advice


Related Topic Tags
field service, inspection methods and plans, process verification and validation, medical devices (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 26th August 2010, 12:50 AM
QE's Avatar
QE

 
 
Total Posts: 248
Question Medical Device Field Service Performance Inspection Process Validation

Dear Coves.

I am working on a project as a QE to review and approve a plan and protocol which validates a performance inspection process performed by the service group on the devices in the field distributed by the firm. Can any one provide some specific guidance available by the FDA or something developed from their own experience please?

Sponsored Links
  Post Number #2  
Old 26th August 2010, 08:49 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Medical Device Field Service Performance Inspection Process Validation

I don't know of specific guidance for validation of a performance inspection process, but general guidance for validation of processes is at http://www.fda.gov/MedicalDevices/De.../ucm122439.htm.

CDER, CBER, CDRH and CVM also jointly publish another guidance, http://www.fda.gov/Drugs/GuidanceCom.../ucm124720.htm, which doesn't show up in searches at CDRH since it's in the CDER document structure.

And of course there's GHTF's /SG3/N99-10 at http://www.ghtf.org/documents/sg3/sg...0_edition2.pdf.
Sponsored Links

Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Re-validation of Out Sourced Medical Device Sterilization Process Ktrna ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 16th December 2011 10:23 PM
Medical Device Inspection Sheets - Excel Spreadsheet Validation rmurp US Food and Drug Administration (FDA) 2 3rd April 2011 08:14 AM
21 CFR 820.75 Process Validation for Medical Device Software singber 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 19th January 2011 12:05 PM
Visual Inspection Validation - Developing a New Medical Device JoseCZ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1 17th November 2007 05:24 AM



The time now is 06:37 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.
A Peachfarm LLC Internet Property