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59 Results
Type: Video
Section: Industry News > Regulatory
Medical Devices
What Is The Goal of the GS1 US Barcode Assessment?
The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated Unique Device Identifier (UDI), healthcare providers aren’t consistently scanning those barcodes at the point of care.
July 9, 2025
Regulatory
Why Med Device Manufacturers Shouldn't Ignore Sterilization Cycles
While contract sterilizers hold the most responsibility to comply with EPA sterilization cycle requirements, MDMs play an important role in reducing gas exposure, says Wendy Mach, Packaging and Sterilization Expert at Canyon Labs.
May 7, 2025
Regulatory
How to Answer an FDA Warning Letter
Today’s manufacturing and packaging experts offer a range of advice for how to proceed and what to avoid when warning letters are delivered.
March 14, 2025
Traceability/Serialization
RFID Product Tracing Through the Point of Care
CCL Healthcare
Hospitals, pharmacies, and patients can access product data—including authentication, recalls, and expiration—with a simple RFID scan or smartphone tap via smart labels from CCL Healthcare’s eAgile.
April 10, 2024
Labeling/Printing
Solution for Expiry Labels, DtP, and Study Timelines Due to EU 536/2014 Clinical Trials Regulation
The new regulation improves many aspects of clinical preparation and activation but brings certain new challenges for sponsors.
March 18, 2022
Aseptic/Sterile
Safety in Aseptic Filling
FDA provides insight into common pitfalls found during inspections along with possible solutions.
January 21, 2022
Inspection
Expedite Med Device Approval with FDA’s New Program
Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.
April 30, 2021
Regulatory
Pre-Fabricated POD for Filling? Don’t Overlook One Key Topic | Modular: The Modern Way of Manufacturing Injectables
If you’re implementing a pre-fabricated POD at your facility, this Take Five video answers why you can’t overlook space for support systems. Also covered: As injectables increase, they become more customized, requiring modular, future-proof equipment.
April 16, 2021
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
Regulatory
Applying GS1 Standards for the DSCSA
One-day workshop Jan. 18, 2017 is designed to help prepare manufacturers, wholesale distributors and healthcare providers to meet DSCSA requirements.
December 13, 2016
Regulatory
Industry Fallout from Unique Device Identifier Mandates
David McGurk, Director of Sales, USA, at Plexpack, shares a front-line perspective on key healthcare packaging market drivers, such as Unique Device Identifiers, and the equipment options available for filling and sealing validatable bags.
November 27, 2016
Regulatory
Planning for FDA Compliance on Class 1 Medical Devices
A five-minute discussion with Paul Johnson, Packaging Solutions Specialist, Life Sciences, at Weber Packaging, offers practical advice on Unique Device Identifier labels to stay ahead of impending compliance deadlines.
November 27, 2016
Labeling/Printing
Planning for FDA Compliance on Class 1 Medical Devices
A five-minute discussion with Paul Johnson, Packaging Solutions Specialist, Life Sciences, at Weber Packaging, offers practical advice on Unique Device Identifier labels to stay ahead of impending compliance deadlines.
November 27, 2016
Packaging/Filling
Integrated Cartoner with Coding and Verification for Efficient Serialization
The balcony-style Cariba C222 cartoner—with quick 15-minute changeover—connects to the MG2 ACE CT/400 coding and verification unit from MG America for precise indexing and transport of blister packs.
November 18, 2016
Inspection
Machine Vision Inspection and Automatic Identification
New product integrations of machine vision and smart cameras used for both inline and offline and barcode and data matrix readers/verification. Systems are configurable and are used by customers in validated industries, such as pharmaceuticals and medical devices.
November 18, 2016
Inspection
Serialization Software
Robust software addresses pharmaceutical counterfeiting and diversion; works with variety of camera and coding/marketing systems to create serialized numbers and then inspects codes printed onto packaging materials.
November 18, 2016
Traceability/Serialization
Serialization expert talks progress, challenges and successful outcomes
Optel Vision’s Jean-Pierre Allard discusses the training challenges companies face, as well as how serialization and aggregation are improving customers’ operations.
November 18, 2016
Materials
Healthcare Supply Chain Management Meets Just-in-Time Demands
An interview with Lee Pretsel, Group Vice President at CCL Healthcare, probes the value proposition of managing today’s just-in-time supply chain with connected ERP systems that help suppliers foresee demands, plan more efficiently and hold less inventory.
November 16, 2016
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