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Healthcare Packaging Validation, Compliance & Documentation News

Articles report on validation, compliance and documentation issues in the healthcare packaging industry. News briefs, columns and white papers focus on information and documentation involved in complying with verification, qualification, and validation guidelines and regulations from agencies and organizations, including quality-related issues.

Examining the different approaches or the traditional qualification model and the risk-based system now being encouraged by regulators.
December 16, 2014 | News

Quality risk management: an industry/regulatory perspective

Examining the different approaches for the traditional qualification model and the risk-based system now being encouraged by regulators.
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Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
December 10, 2014 | News

Patent cliff to cause $65 billion sales loss

Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
December 3, 2014 | News

Who should be accountable for medical device and healthcare cybersecurity?

In the recent letter to the FDA, the American Hospital Association believes the responsibility lies with medical device manufacturers.
DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
November 14, 2014 | News

DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015

Topics to be covered March 3-5, in Virginia Beach will include technology for manufacturing innovation, package design, sealing process validation, and a local operating nurse panel.
Benefits of packaging line simulation
November 13, 2014 | Feature Article

Benefits of packaging line simulation

Pharma EXPO presenters illustrate benefits of using simulation for both new and existing lines.
November 11, 2014 | Product Brief

Strategic Cold Chain Management: USP, EC and Evolving Storage & Shipping Practices

With this eBook, Vaisala gives simple, applicable recommendations on how to apply the guidance and recommendations from USP, EC and others.
Next-Gen manufacturing benefits Amgen. This photo is for illustrative purposes only.
October 6, 2014 | News

Amgen's Next-Gen manufacturing

New plant in Singapore uses disposable, single-use processing components designed to eliminate the need for cleaning and sterilization, and the validation that goes with it.
This is an image of a refrigerated truck, for illustrative purposes.
October 1, 2014 | News

Watch for expanded Chapter <1083> topics

Chapter <1083> Good Distribution Practices expanding scope to include APIs, excipients, dietary supplements, and more.
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity.
September 29, 2014 | Column/Opinion

Reevaluating drug product stability can save millions on packaging

Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.
September 25, 2014 | News

Pharmaceutical packaging innovation advances quality, speed, and efficiency

Latest technologies and educational opportunities showcased at Pharma EXPO.

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