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FDA, Regulatory & Legal Developments in Healthcare Packaging

Articles examine the legal and regulatory developments in healthcare packaging. Topics discussed include guidances, rulings and governmental issues that affect the packaging of drugs, biologics, and medical devices. Legal and regulatory experts from around the industry provide columns that offer depth and insight to these key issues.

National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
October 23, 2014 | News

FDA helps small medical device companies innovate quicker

National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
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FDA announcements touch upon healthcare packaging and regulatory issues
October 20, 2014 | News

FDA announcements touch upon healthcare packaging and regulatory issues

Agency addresses increasing complexity of FDA’s mandate, globalization in the supply chain, and the trend of rapid scientific innovation.
October 16, 2014 | News

Roche's Ebola Virus Test Could Be Fast-Tracked by FDA

Laboratories who want to handle Ebola samples would have to meet specific safety requirements.
Skincare balm comes in 3D-printed, PLA container
October 15, 2014 | Package Case Study

Skincare balm comes in 3D-printed, PLA container

Anita’s Balm founder brings package manufacturing in-house, creating a custom twist-up container resembling a mini amphora jar, made from compostable PLA resin.
FDA announces medical device cybersecurity guidance
October 13, 2014 | News

FDA announces medical device cybersecurity guidance

Agency to hold Oct. 21 and 22 public workshop on collaborative approaches for medical device and healthcare cybersecurity.
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.
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.
FDASIA strengthens agency’s authority
September 26, 2014 | News

FDASIA strengthens agency’s authority

Reviewing provisions of the legislation that impact drug product inspections.
September 24, 2014 | News

Changes made to EU Guidelines for GMPs

Chapter 5, sections 17 to 21 revisions provide guidance that aims to help prevent cross-contamination and benefit supply chain traceability.
GS1 US has published a guideline that details how to implement GS1 Standards to support the 2013 Drug Supply Chain Security Act (DSCSA), and enhance patient safety and security in the pharmaceutical supply chain. (This photo is for illustration purposes only.)
September 17, 2014 | News

Guideline delineates how to implement GS1 standards

Document provides intelligence to support pharmaceutical lot-level management and future item-level traceability requirements

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