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Regulatory: Page 21

Regulatory
Demystifying FDA’s ASCA on Biocompatibility for Expedited Review
Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.
April 7, 2021
Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?
Inspection
5 Tips To Improve Your Remote/Hybrid Audits
Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our "Take Five with HCP" video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.
April 2, 2021
Hcp Base
Market Trends
PDA’s 2021 Honor Awards
The Parenteral Drug Association (PDA)
Honorees include those who work in packaging science, automated visual inspection, and more.
March 24, 2021
Martin VanTrieste
Regulatory
PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs
The Parenteral Drug Association (PDA)
Courses to cover many PDA areas of expertise, including aseptic processing.
March 21, 2021
Pda Dk Blue Tag Below
Packaging/Filling
5 Tips on Remote Auditing Contract Organizations
Switching to hybrid or virtual audits? Check out these tips for a smoother transition. Additionally, PDA is holding a remote audit and inspection workshop Apr. 8.
March 15, 2021
Getty Images 1060972482
Regulatory
PDA Post-Approval Change Issues and Impacts Survey
PDA
This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.
February 24, 2021
Getty Images 488635873
Regulatory
3 Key Takeaways from the EMA Clinical Trial Guidance Update
New version addresses remote source data verification amid the COVID-19 pandemic.
February 18, 2021
Eu Flags
Temp Control/Cold Chain
How FDA Food Supply Data Supports COVID-19 Vaccine Distribution
In the latest FDA Voices post, Dr. Stephen Hahn and Frank Yiannas, M.P.H. discuss how the new data analysis tool, 21 FORWARD, is helping food and agriculture workers receive vaccines.
January 20, 2021
Getty Images 1230124575
Traceability/Serialization
Serialization 101
Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting.
January 13, 2021
Getty Images 1178747427
Market Trends
Quotables and By the Numbers to Start the Year
Quotes and stats on clinical trial demographics, modes of transportation, the personalized medicine market, and more...
January 7, 2021
Getty Images 627196908
Traceability/Serialization
Counting Down the Top 10 Articles of 2020 - #8: CDMO Speeds Line with L4 Serialization
Join us as we look back at the most-read Healthcare Packaging stories of 2020. At #8, we cover one CDMO’s implementation of an open-source serialization system.
December 23, 2020
1 Img 3321
Robotics/Automation
Serialization Continues to Impact Pharma Automation Investments
Automation and IoT are on trend, as the industry continues to meet serialization regulations.
December 10, 2020
Getty Images 136641043
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Top Stories
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
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.
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
3D printer setup with supply bottles and industrial equipment on red platform
Package Development
Designing the Convenience of Tamper Evidence
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
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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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
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
View More »
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