Validation, compliance and documentation

DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
News
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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.
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Schlegel presents status of guidelines for Factory Acceptance Tests
News
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Best practices for Factory Acceptance Testing to emerge in 2015

Will packaging and other machines be easier and more cost-effective to purchase and install in the future? More than 100 consumer packaged goods companies and 25 of their vendors are working with AIOE on new guidelines that could help make it happen.
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity.
Column/Opinion
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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.
Controls Product Brief
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Contemporary Graphic Solutions: Online compliance and productivity

Software services suite handles design, print, and packaging product life cycle aspects to increase efficiencies and financial savings.
Onset: Temperature data logger
Machine Product Brief
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Onset: Temperature data logger

HOBO MX1101 transmits temperature and relative humidity data to mobile devices via Bluetooth Smart.
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
Column/Opinion
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The case for and against RFID in pharma

Reaching necessary read accuracies remains a challenge in pharmaceuticals, but RFID could still prove useful.
PharmaExpo tracks will be divided into Manufacturing Operations, Compliance Trends, and Pharmaceutical Packaging.
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Full conference program announced for Pharma Expo

Tracks will be divided into Manufacturing Operations, Compliance Trends, and Pharmaceutical Packaging.
U.S. pharmaceutical firm orders auto injector production. Shown here is the fully automated insertion of a spring into a plastic auto injector component.
Feature Article
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U.S. pharmaceutical firm orders auto injector production

Consisting of 14 plastic components and three metal parts, the auto injectors are used for the treatment of moderate to severe active psoriasis arthritis.
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is an independent consultant and founder of RxTrace.
Column/Opinion
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Congress should have mandated randomization

Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.
Inventory counting is a benefit gained by Sharp Packaging.
Machine Case Study
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Sharp Packaging to gain 10-month ROI on tablet counter

A successful validation study leads to a pharmaceutical contract packager’s use of tablet counters on all its bottling lines and small-quantity bottle filling.

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