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Regulatory: Page 28
Regulatory
FDA Guidance: Providing Regulatory Submissions for Promotional Labeling and Advertising Materials
Final guidance includes seven examples of appropriately submitted promotional materials, including video games, exhibit booth banners, and kit materials.
June 21, 2019
Regulatory
DSCSA: Post-Serialization Depression & What’s to Come
Over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect, manufacturers continue to struggle with Post-Serialization Depression (PSD).
June 11, 2019
Traceability/Serialization
ACG Inspection Installs 1,000th Track & Trace Line
ACG’s comprehensive serialization services implemented in more than 100 countries around the world.
June 10, 2019
Traceability/Serialization
Q&A: The Impact and Benefit of Serialization on Rare Disease Therapies
At FutureLink Barcelona 2019 in June, the serialization discussion will focus on the value of digital information sharing Can healthcare manufacturers use data to help patients and physicians?
June 7, 2019
Regulatory
Live from AIPIA: RFID Tags Could Save the U.K. National Health Service $500M/year
Diagnostic samples bound for one of the U.K.’s NHS pathology labs get a reusable storage system and low-cost RFID labels that save packaging, staff, and operational costs, among other benefits.
June 6, 2019
Traceability/Serialization
Contract Packaging Organization Digitizes Supply Chain Operations
Central Pharma selected the Veratrak platform to help achieve digitized end-to-end visibility of the supply chain and improve collaboration.
June 4, 2019
Regulatory
Part 2: Tips for Revamping Your Artwork Approval Process
Overhauling the artwork approval process? A senior labeling manager at Bausch Health shares tips about what to consider before you start including allocating resources and time, and the importance of work instructions.
May 22, 2019
Regulatory
Part 1: Tips for Revamping Your Artwork Approval Process
Overhauling the artwork approval process? A senior labeling manager at Bausch Health shares tips about what to consider before you start.
May 21, 2019
Regulatory
Cosmetics Claims: Stay In Your Lane
Claims to alter one’s appearance are OK, but cosmetics that claim effect on structure or function the body are, legally, drugs.
May 14, 2019
Traceability/Serialization
Antares Vision: Line Efficiency Monitoring System
AVionics is designed to utilize data collected for serialization compliance to help improve production practices. The system monitors real-time production status, instant and accumulated speed, overall equipment efficiency and camera performance.
May 10, 2019
Regulatory
UDI: FDA Finalizes Guidance for Convenience Kits
The guidance features clarification of concepts, examples and a Q&A section to help manufactures determine when individual components of a kit require labeling.
April 29, 2019
Labeling/Printing
Electronic Position Indicators Ensure Process Security in Track-and-Trace Systems
Compliance with the EU FMD requires implementation of traceability systems. The TQS (Traceable Quality System) from WIPOTEC-OCS employs a position indicator from SIKO GmbH that offers process security during format changes.
April 25, 2019
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Top Stories
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Package Development
Designing the Convenience of Tamper Evidence
Products
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Robotics/Automation
Automation Success on the Line
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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