International regulators agreed on a set of principles for building a harmonized Global UDI system throughout the medical device supply chain. Today, variances between medical device regulations in some jurisdictions has impacted the supply chain. Learn how to overcome these challenges and to take advantage of the opportunities a Global UDI system brings to manufacturers and hospitals.
This webinar will discuss:
The importance of the UDI device triggers, data quality requirements and validation rules.
Master data management and how to support data registration to numerous regulatory databases.
Maintaining globally compliant labels and the impact of regulator and manufacturer actions on the adoption of UDI across the device ecosystem.
Ideas to reduce variability and increase the value of the device label as a communications tool.
A quick, condensed, and powerful PowerPoint style overview of Innovatum as a company and their ROBAR Enterprise Labeling System including topics such as: Company Overview, Notable Customers, and Efficiencies Gained Through the System.
Additional areas covered include, Label Creation and Process Controls, Artwork Management, Management of Raw Data / Metadata, Multi-User Electronic Label Approval, Redlining, Batch Record Creation Issuance, Label Reconciliation, Traceability, Destination Labeling, Labeling System Architecture, 100% Automated Print Inspection, Scalability and High Availability, Ease of Integration, Data Push and Pull Capabilities, Maintenance and Support.
Local regulatory bodies globally are enforcing the requirement for product labels to contain translated content and hazard indications (GHS), other symbology, and regionally specific information in order to permit entry and sale in geographies under their jurisdiction.
Destination Labeling is a concept that is also referred to as Country Specific labeling. And it has become a significant source of consternation for labeling operations in global manufacturing organizations.
This presentation will delve into some of the solutions that have been implemented and possible alternative approaches, including augmentation of labeling with additional destination-specific labels.
This video analyzes infrastructure, AIDC, and system requirements for a destination labeling operation.
Learn about Zimmer Biomet’s implementation of their Global Enterprise Labeling System and its use in preparing for EU MDR
New labeling system enables regulatory compliance and unprecendented systems efficiencies at medical device manufacturer Zimmer Biomet
As medical device manufacturer Zimmer Biomet grew through merger and acquisition, they sought to harmonize different labeling systems across their global facilities with two goals in mind: to gain the efficiencies that standardized labeling processes offer; and to enable global compliance, especially with the pending European Medical Device Regulation (EU MDR). Zimmer Biomet chose ROBAR software from Innovatum, with label design and print powered by BarTender®.
Please click the link below to download your Report:
Innovatum President and CEO, Ardi Batmanghelidj, will be one of 3 subject matter experts who will be providing Regulatory insight into Packaging and Labeling, eIFU, CAPA for Packaging, UDI and MDR as part of the upcoming Orange County Regulatory Affairs (OCRA) webinar September 23, 2020.
Mr. Batmanghelidj will be discussing EU MDR, Eudamed and associated requirements as they relate to labeling challenges. These challenges primarily center around the increasing amount of data required for labels & UDI. Yet all challenges can be helped by creating a “single source of truth” through MDM architecture that enables continuous system expansion. MDM mapping with different regulatory systems worldwide rounds out the picture.
Heading up a software company specializing in labeling and regulatory compliance since 1993, Ardi has amassed extensive hands-on experience in the Life Sciences industry. He has continuously shared his expert guidance with the FDA and manufacturers in the areas of master data management, labeling and barcoding. Ardi is presently contributing to the MedTech Europe working group for EUDAMED machine to machine communications.
Attendance at the webinar awards 2 hours toward your RAC certification. The Discount Code to attend this webinar FREE of charge is: INV3
Click here for registration instructions, speaker schedules, and all Abstract details.
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