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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.

Healthcare packaging seminar May 6-7, 2014 to address challenges faced in China, including medical package design, validation, and regulatory issues.
April 15, 2014 | News

First LifePack Forum slated for Suzhou, China

Healthcare packaging seminar May 6-7, 2014 to address challenges faced in China, including medical package design, validation, and regulatory issues.
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BLISTER PACK. This compliance-prompting pack for a clinical trials application includes room for patient initials and date dispensed.
March 12, 2014 | Feature Article

The changing face of clinical trial services

A contract packager examines trends affecting the pharmaceutical industry.
MD&M West 2014: Touchscreen system
February 27, 2014 | Video

MD&M West 2014: Touchscreen system

Makes it easier for customers with validation needs. Demonstrates how machine seals pouch, then date-code, all in one step. Prevents operator from selecting incorrect setting, maintaining validation repeatability.
Sonoco ThermoSafe: CRT prequalified shippers
January 27, 2014 | Materials Product Brief

Sonoco ThermoSafe: CRT prequalified shippers

New insulated shippers ensure 15° to 25°C protection for pharmaceuticals and other high-value biologics for a minimum of two days.
January 17, 2014 | Feature Article

Getting started with pilot tests

Once you’ve identified your goals, you should start giving thought to selecting one or more sites, lines, SKUs, vendor technologies, and trading partners for your pilot test(s).
January 12, 2014 | Feature Article

Avoid these EPCIS interoperability pitfalls

One of the greatest challenges facing the pharmaceutical supply chain is hooking up multiple ERP systems and business applications across the supply chain, spanning the manufacturer, contract packager, wholesaler/distributor, and pharmacies. Ensuring interoperability of the data across the supply chain is a challenge, even if all parties adopt GS1’s EPCIS standard.
January 11, 2014 | Feature Article

Issues with master data

Trading partners with whom you exchange EPCIS event data will request what is known as “supply chain master data” about your products, company, and locations that will be referenced in EPCIS events. This data takes two basic forms.
January 10, 2014 | Feature Article

Determining goals and metrics for pilot testing

There are two schools of thought when it comes to pilot testing.
January 4, 2014 | Feature Article

Validation considerations for serialization

As a rule of thumb, validation adds 25% to the cost of any changes required by serialization.
December 22, 2013 | Feature Article

Staffing for success: Building a proper serialization team

Serialization requires input both at the planning stage and during execution from multiple departments as well as external trading partners.

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