Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


android tablet pc

Home > Press > Technical Guide for US FDA-Regulated Organizations

Abstract:
Now Available — "How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments"

Technical Guide for US FDA-Regulated Organizations

Richmond, BC, Canada | Posted on February 11th, 2010

"How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments" is now available from Veriteq, a leader in FDA-compliant environmental monitoring, alarming, reporting and temperature/humidity technology.

The 10-step Guide is designed to help the wide range of pharmaceutical processors, blood and tissue banks, clinical laboratories, medical device manufacturers, research hospitals, and other GxP facilities who may receive public criticism warning letters respond quickly and appropriately within the permitted 15-day window. Proper FDA 483 letter response is critical to both help in reputation repair and for real remediation actions to assure a quality process and patient safety.

FDA 483 letters are expected to increase this year, reflecting the FDA's recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window.

Ken Appel, Veriteq Vice President Regulated Markets, comments, "Veriteq is keenly aware of the great number of FDA-regulated companies that thought they were in full compliance but were not when it came to temperature monitoring. Since Veriteq offers the only monitoring system that ensures both gap-free records and accuracy in between calibration intervals we have always had customers who came to Veriteq because they were using inferior solutions. Customers are often disappointed over the failure of chart recorders or data loggers to record data during facility power outages, hold calibration accuracy of sensors or other equipment failure that had triggered negative FDA actions or product loss. If and when a company receives a Warning Letter it is a matter of public record listed on the FDA's web site. Veriteq's guide-"How to Avoid and Respond to Public FDA Criticisms-Form 483 Letters-for Temperature, Humidity and other Controlled Environments" will help quality departments that have received such public criticism regroup, but more importantly, will give some best-practice tips that will help FDA-regulated organizations avoid Warning Letters in the first place."

To obtain a copy of the Guide fill out the request form at www.veriteq.com/fda_response.htm or contact: Janice Bennett, Veriteq Marketing Manager, 800-683-8374 (or +1-604-273-6850 outside North America), FAX 604-273-2874.

####

About Veriteq
Veriteq Instruments provides environmental monitoring of temperature, humidity and other critical variables in controlled environments for regulated industries and other critical storage applications where product loss or audit failures are unacceptable. A network of independent data recorders equipped with industry-best 10-year batteries deliver monitoring, alarming and reporting with a continuous record of data, immune from power outages and network interruptions. Headquartered in Richmond, BC, with a worldwide distributor network (www.veriteq.com/contact/index.htm) Veriteq serves thousands of users, from Global 500 companies and major learning, standards and government institutions to mid-sized research and manufacturing organizations.

For more information, please click here

Contacts:
Amy Munice
ALM Communications
+1-773-862-6800
(skype) ALMCommunications

Copyright © Veriteq

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

'Exotic' material is like a switch when super thin April 18th, 2014

Innovative strategy to facilitate organ repair April 18th, 2014

Oxford Instruments Asylum Research Introduces the MFP-3D InfinityTM AFM Featuring Powerful New Capabilities and Stunning High Performance April 18th, 2014

Conductive Inks: booming to $2.8 billion by 2024 April 17th, 2014

Preparing for Nano

Durnham University's DEEPEN project comes to a close September 26th, 2012

Technical Seminar at ANFoS 2012 August 22nd, 2012

Nanotechnology shows we can innovate without economic growth April 12th, 2012

Thailand to host NanoThailand 2012 December 18th, 2011

Govt.-Legislation/Regulation/Funding/Policy

'Exotic' material is like a switch when super thin April 18th, 2014

Innovative strategy to facilitate organ repair April 18th, 2014

Novel stapled peptide nanoparticle combination prevents RSV infection, study finds April 17th, 2014

INSCX™ exchange to present Exchange trade reporting mechanism for engineered nanomaterials (NMs) to UK regulation agencies, insurers and upstream/downstream users April 17th, 2014

Announcements

'Exotic' material is like a switch when super thin April 18th, 2014

Innovative strategy to facilitate organ repair April 18th, 2014

Oxford Instruments Asylum Research Introduces the MFP-3D InfinityTM AFM Featuring Powerful New Capabilities and Stunning High Performance April 18th, 2014

Transparent Conductive Films and Sensors Are Hot Segments in Printed Electronics: Start-ups in these fields show above-average momentum, while companies working on emissive displays such as OLED are fading, Lux Research says April 17th, 2014

Interviews/Book Reviews/Essays/Reports/Podcasts/Journals

'Exotic' material is like a switch when super thin April 18th, 2014

Innovative strategy to facilitate organ repair April 18th, 2014

Novel stapled peptide nanoparticle combination prevents RSV infection, study finds April 17th, 2014

Thinnest feasible membrane produced April 17th, 2014

NanoNews-Digest
The latest news from around the world, FREE







  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE