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Product News: Technical Guide for U.S. FDA-Regulated Organizations
“How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments”
Product News: Software Unifies Product Development for Medical Device Companies
Cognition Cockpit allows companies to close the gap between CAPA, complaints, risk management, and requirements management.
URAC Pharmacy Accreditation Programs Open For Public Comment
Public input sought for revised standards and new performance measures.
ISO Gives Food Manufacturers New Tool to Control Hazards
ISO/TS 22002-1—“Prerequisite programs on food safety—Part 1: food manufacturing”
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
Agency says Bayesian statistical methods could trim costs, boost efficiency.
BSI Unveils “Passport to Europe” Program
Program educates medical device manufacturers on CE marking regulatory process and breaking into European market.
Event: Next Generation Complaint Management for Medical Device Industry
Free Live Webcast—Thursday, Jan. 21, 1 p.m. EST.
Product News: Thermo Fisher Scientific UV-Visible Spectrophotometer Web Tool
Update features the newest technological developments
Harvard Pilgrim to Develop FDA Pilot for Safety Monitoring System
Sentinel System will bolster the FDA’s efforts in monitoring product safety.
Product News: IQS Announces New Problem Solving Capabilities
Streamline and strengthen the problem solving process by promoting collaboration.
TÜV SÜD Canada Inc. Acquires Global Advantage International
Product safety testing capabilities increased for Canadian market.
Book: Quality Management—Theory and Application
New book establishes quality as a key element of management practices.
Product News: ProFicient 4 Improves Quality, Compliance, Production
Shearer’s Foods implements software to enhance automated quality control.
Cutting Through the “Green” Gift Hype This Christmas
Consumers must wade through a sea of green promises.
Product News: GAGEtrak Validation Guide
For when the FDA says it’s up to you but you haven’t a clue.
CLSI Publishes New Proposed Guidelines
For manufacturers, clinic labs, and patient-care facility management
Product News: Thermo Fisher Scientific, Multiresidue Analysis of Pesticides
New method enables rapid and accurate identification and quantification of pesticides in rice.
Product News: XP105 Analytical Balance Lends Safety, Accuracy to Lab Applications
Reduces the risk of errors, increases efficiency, and is easy to use
Product News: TempTrackr Wireless Temperature Measurement System Kit
Evaluation kit for passive, wireless temperature monitoring for industrial process control applications
ISO Starts Work on Consumer Products Safety Standard
Provides guidance to all parties involved in the consumer product supply chain

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