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Validation, compliance and documentation

Stories that report on the information and documentation involved in complying with verification, qualification, and validation guidelines and regulations from agencies and organizations, including quality-related issues.

Sanofi Pasteur launches 2D bar coding for pediatrics

New vaccine packaging technology to capture more information than simple 2D coding, including lot numbers and expiration dates, to improve patient care and office efficiencies....

Sunkist's pouch tops Healthcare Packaging's top 10 in 2011

Package innovation, trends, regulations, and track-and-trace issues pique reader interest....

Video: Video: Pick-and-place equipment for pharmaceutical/medical device applications

In this exclusive video, Jon Otto, a product manager at Bosch Packaging Technology discusses film structures, seal integrity, vision systems, speed, accuracy, and validation advantages of robotic-pick and place machinery that eliminates human product handling and helps provide consumer safety....

Packaging ‘pain points’ reveal frustrations

Validation, regulatory/standards, and cost issues top the list of laments for respondents of recent Healthcare Packaging reader survey....

World healthcare IT market expected to reach $162.2 Billion by 2015

Report forecasts global healthcare IT market will rise at a Compound Annual Growth Rate of 10.2% from 2010’s $99.6 Billion....

Understanding best practices for combination product package stability and validation

Hear Synthes USA’s Packaging Validation Supervisor Laure L. Larkin explain FDA governing documents as well as the ISO counterparts....

FDA Speaker Grace McNally to Present on USFDA’s New Process Validation Guidance at ISPE 2011 Tampa Conference

Attendees of ISPE’s 2011 Tampa Conference on Applying Solutions to Emerging Industry Challenges will have the chance to learn first-hand about the implications of the FDA’s newly-updated Guideline on General Principles of Process Validation as part of one the event’s...

Temperature-monitoring labels

Storage system for hospital pharmacies

• WillCall Rx™ combines advanced storage and retrieval capabilities with simple software to automate hospital pharmacy fulfillment • provides secure storage that is Health Insurance Portability and Accountability Act (HIPAA)-compliant • carousel storage provides a self-contained enclosure with two...

ISPE’s updated GAMP® Guide addresses changing regulatory environment

Changing approach to validation and compliance adds more focus to process control system reliability....

Using risk assessment in validation and documentation

Some Healthcare Packaging survey respondents validate ‘everything,’ while others limit risk assessment to critical equipment or processes....

ISPE Risk-maPP conference attendees to receive new Baseline® Guide

Attendees will hear from companies that have implemented Risk-MaPP principals, receive downloadable copy of Guide....

Validation insights for medical device packaging

Medical device packaging validation can be confusing, so here are a few helpful resources to guide your efforts....

Compliance Checklist for FDA-regulated Companies Now Available from Dickson Company

Worldwide food and drug companies selling to the U.S. market can now obtain a free FDA 21 CFR Part 11 Checklist to ensure full regulatory compliance of their environmental monitoring practices....

Compliance risks and package validation mistakes

Examining common medical device package development/validation errors, and five compliance risks facing life-science firms....

Manage your validation missions with GxP Manager*

As a Validation Manager, you know the validation team is usually the last on the scene when money and time have run out!...

First DataBank Joins Health 2.0 Accelerator Consortium and Partners with PharmaSURVEYOR*

First DataBank, a leading provider of integrated drug databases for the healthcare industry, today announced that it will join PharmaSURVEYOR and a growing list of "Health 2.0 companies" as participants in the Health 2.0 Accelerator, a consortium focused on promoting...

Inventory control software

• FastPic5® software for health care users provides improved tracking, validation, and traceability...

Outsert systems

• MV-08 (shown) is a single knife-folder system that folds evenly sealed outsert leaflets with up to 110 panels...

A change of course for pharmaceutical manufacturing

The FDA’s Quality-by-Design initiative holds potential to transform the pharmaceutical industry’s approach to drug development and manufacturing....

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