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402 Results
Type: Article
Section: Industry News > Regulatory
Sustainability
Medical Device eIFUs: Hurdles to Overcome
Live from the[PACK]out: Regulations, regional acceptance, and validated packaging configurations all play a role. The challenges aren’t insurmountable but will require efforts from the packaging community.
May 12, 2022
Medical Device/Packaging
KiiP Tackles Wicked Problems in Package Material Stability
What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out's inaugural event in Austin.
May 10, 2022
Market Trends
Quotables and By the Numbers: May 2022
Quotes and stats in healthcare packaging and logistics, from distribution to sustainability and beyond...
May 3, 2022
Temp Control/Cold Chain
10 Temperature Monitor Qualification Considerations
From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.
April 15, 2022
Pharmaceuticals
Future for Pharmaceutical Manufacturers Includes More Digitized Data Collection
PMMI
While automation is driving physical changes to pharmaceutical production and packaging processes, another significant shift is occurring in the accumulation and use of data.
March 14, 2022
Regulatory
Manage Challenges from the EU 536/2014 Clinical Trials Regulation
Plan ahead for study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.
March 10, 2022
Supply Chain
Tips for Exporting Goods in 2022
Live from Natural Products Expo West: An international trade expert discusses why you need to know your buyers, what you can ship to a sanctioned country, insurance for sea cargo, and more.
March 9, 2022
Regulatory
Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
From personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 5, 2022
Traceability/Serialization
Counting Down the Top 10 Articles of 2021 - #1: Serialization 101
Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.
January 4, 2022
Robotics/Automation
Counting Down the Top 10 Articles of 2021 - #4: Data and AI Accelerate Digital Transformation
Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #4, we cover the growing need for pharma manufacturing facilities to become digitalized to improve productivity and make the most of the ‘digitally native’ workforce.
December 29, 2021
Traceability/Serialization
Counting Down the Top 10 Articles of 2021 - #9: Exchanging Pharma Master Data in 2021
Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #9, we cover the exchange master data to meet DSCSA requirements with EPCIS (Electronic Product Code Information Services) files.
December 21, 2021
Traceability/Serialization
FDA Discusses Nov. 2023 DSCSA Future State
At the HDA Traceability Online Seminar (Nov. 1-3, 2021), FDA’s Connie Jung, RPh, talked about how DSCSA continues to transform the pharmaceutical supply chain to preserve drug safety and security.
November 30, 2021
Market Trends
Quotables and By the Numbers: November 2021
From choosing a mentor to DSCSA readiness to the printed sensor market, quotes and stats in healthcare packaging and logistics.
November 23, 2021
Traceability/Serialization
Will Labor Requirements Increase in Meeting DSCSA Milestones?
With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.
November 18, 2021
Regulatory
Applying Modern Technology to Pharmaceutical Production Facilities
Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.
November 16, 2021
Sustainability
EU Regulators, Recycling, and Healthcare Plastics
Packaging suppliers speak about the openness of regulators to understand the slower nature of life science manufacturers in adopting more sustainable packaging.
November 11, 2021
Traceability/Serialization
HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization
Healthcare Distribution Alliance (HDA)
With 2023 DSCSA requirements around the corner, findings reveal aggregation has slowed. Now in its sixth year, this survey, released as part of HDA’s Traceability Online Seminar (November 1–3), assesses industry abilities to meet DSCSA requirements.
November 1, 2021
Medical Device/Packaging
Safety Factors for Ethylene Oxide Sterilization: Patient, Worker, and Environment
The common medical device sterilization method requires optimization, particularly with potential regulatory changes on the horizon. Emissions limits could become more stringent by as much as 90% per one technical affairs VP.
October 28, 2021
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![At the[PACK]out, presenting 'Wicked Stability: Predicting the Aging Degradation of Materials' were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch w/ Moderator Seema Momin.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2022/05/Wicked_Stability.627af09af0762.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
