Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
Forum Username

Wooden Line

Medical Device Field Service Performance Inspection Process Validation

Wooden Line
Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

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

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

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
  #1  
Old 26th August 2010, 12:50 AM
QE's Avatar
QE

 
 
Posts: 239
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
  #2  
Old 26th August 2010, 08:49 AM
MIREGMGR

 
 
Posts: 3,375
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 Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)

Do you find this discussion thread helpful and informational?


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 09:23 PM
Medical Device Inspection Sheets - Excel Spreadsheet Validation rmurp US Food and Drug Administration (FDA) 2 3rd April 2011 08:14 AM
Visual Inspection Validation - Developing a New Medical Device JoseCZ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1 17th November 2007 04:24 AM
Sample Sizes for Process Validation - Medical device manufacturer achenry ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 6 13th March 2006 05:40 PM



The time now is 01:50 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".