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1,882 Results
Section: Industry News > Regulatory
Aseptic/Sterile
Safety in Aseptic Filling
FDA provides insight into common pitfalls found during inspections along with possible solutions.
January 21, 2022
Regulatory
FDA Releases Medical Devices Draft Guidance for Review
“The Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency” guidance is now available for review.
January 12, 2022
Medical Device/Packaging
MedAccred Grants Volex Accreditation for Cable and Wire Harness Assembly
MedAccred
Volex is the first company in Mexico to hold the prestigious accreditation for this critical manufacturing process.
January 11, 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
Sustainability
Emerging EU Sustainability Regulations for Packaging
From the European perspective, Thierry Wagner offered an overview of regulations in the pipeline aiming to reduce plastic use and bolster recycling.
October 27, 2021
Supply Chain
2021 HDA Traceability Online Seminar Takes Place Nov. 1-3
Healthcare Distribution Alliance (HDA)
Are you prepared to comply with the DSCSA by 2023? Supply chain stakeholders will convene to discuss the most pressing DSCSA-related topics with experts, including a presentation from FDA.
October 7, 2021
Traceability/Serialization
Mini Manual Aggregation Station for Small- to Mid-Sized Production
Capable of supporting post-lot reworking operations in warehouses and distribution centers, the system is a fit for smaller producers looking to meet upcoming supply chain security requirements.
September 27, 2021
Home
Antares Vision Group to Demo New Mini Manual Aggregation Station for Small- to Mid-Sized Production, Among Other Recently Introduced Traceability & Inspection Solutions
Antares Vision Group
See it at Booths #SL-6502 and #C-3938! Company also will demo “Track My Way,” a traceability platform opening dialogue between various supply chain stakeholders, including consumers.
September 22, 2021
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