Regulatory: Page 74

Materials
Pharmaceutical Makers, CMOs Meet Serialization Challenges Head-On
3rd Serialization Roundtable For CMO’s’ delivers education to a pharmaceutical industry in need.
September 1, 2016
Teva's Vivian McCain, VP, Third Party Operations, Americas.
Packaging/Filling
Sepha: EZ Blister Auto Feed
Lab-scale tabletop blister packaging machine includes material autofeed; ideal for low-volume packaging needs.
August 31, 2016
Sepha: EZ Blister Auto Feed
Traceability/Serialization
Xyntek and Antares Implement Fully Automated Bottle Line for Global Pharmaceutical Organization
The end-to-end process serializes bottles and uses 2D “Helper” codes to streamline unit-to-case aggregation.
August 31, 2016
Xyntek and Antares Implement Fully Automated Bottle Line for Global Pharmaceutical Organization
Temp Control/Cold Chain
Clinical Trial Experts Save Over $1 Million with New Temperature Tracing and the Cloud
Data loggers and cloud-based analytics reduce labor, packaging and freight costs for clinical shipments.
August 30, 2016
Clinical Trial Experts Save Over $1 Million with New Temperature Tracing and the Cloud
Pharmaceuticals
Schreiner MediPharm: Next-Gen Flexi-Cap Plus
The new Flexi-Cap Plus features a tear strip running through the label as an integrated element.
August 29, 2016
Schreiner MediPharm: Next-Gen Flexi-Cap Plus
Pharmaceuticals
University Research Takes New Approach to Battle Counterfeits
Researchers at the Universities of Luxembourg, Ljubljana and Vienna collaborate on non-biometric physical tokens that can’t be cloned or copied.
August 29, 2016
Generating unclonable patterns to fight counterfeiting.
Pharmaceuticals
Medical Tracking Solutions Selects Logi Analytics
Logi software will be embedded into iTraycer, the MTS software, to enhance the customer’s ability to mine data for information for real-time decision-making.
August 26, 2016
Medical Tracking Solutions Selects Logi Analytics
Regulatory
FDA Revises Guidance on Dietary Supplements
The FDA revamps efforts in the fight against shaky medical claims and potentially harmful new ingredients in dietary supplements.
August 25, 2016
FDA Revises Guidance on Dietary Supplements
Pharmaceuticals
Managing Big Data in Healthcare
Life sciences companies have too much information—manually collected, logged and stored to adhere to the highest quality standards. Digital analytics can funnel just the right information for risk management.
August 24, 2016
Inspection imagery of syringes and vials.
Pharmaceuticals
Stemedica’s Clinical Trial Using Cryoport Logistics
Companies expand agreement as biotech firm Stemedica uses Cryoport shippers and monitoring systems for a new Phase II clinical trial to assess a stem cell therapy for the treatment of Alzheimer's disease.
August 16, 2016
Stemedica’s Clinical Trial Using Cryoport Logistics
Materials
Open-SCS Reports Track-and-Trace Model Progress
Focus on standardizing serialization data exchanges across the healthcare supply chain. Next workshop is scheduled for Sept. 2016 in Germany.
August 15, 2016
Open SCS logo
Medical Device/Packaging
Packaging is Part of the Guidance Package
Medical device makers might need FDA guidance more than other manufacturers.
August 12, 2016
Eric Greenberg, Contributing Editor
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Top Stories
Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Products
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
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Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
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