Innovatum is proud to be the Platinum Sponsor of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference taking place September 22-23, 2021 in a virtual meeting format.
The event is open for registration at: https://www.q1productions.com/medical-device-labeling/ and highlights perspectives from regulatory authorities and industry experts to support your team’s labeling quality and compliance. Enter the discount code INNOVATUM to receive 20% off of the registration price.
A joint case study presentation “CONSIDERATIONS FOR END-TO-END LABELING IMPLEMENTATION & OPTIMIZATION” by Aimee Wright- Labeling Manager, Global Labeling Zimmer Biomet and Ardi Batmanghelidj- President and CEO, Innovatum begins at 11:00 Central on day two of the conference September 23, 2021. The session conveys real-world scenarios and covers topics such as:
Comparing varying perspectives into end-to-end labeling
Needs assessment: Full implementation versus upgrade
Technology solutions & related cost considerations
Common execution missteps & lessons learned
This conference is an opportunity to participate in an on-line format with a diverse set of sessions on a variety of topics pertaining to regulatory and labeling concerns for the life sciences industry. The virtual format improves accessibility to the latest information without a need to travel.
We hope you are able to attend.
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.
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.
A regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.
Innovatum, a proud sponsor of the 9th Annual, Q1 Medical Device and Diagnostic Labeling Conference in Chicago, May 14-15, invites you to join this conference at a significantly discounted rate.
This conference with will delve into labeling strategy streamlining and optimizing in a rapidly evolving international regulatory environment with a focus on developing EU MDR and IVDR compliant labels, all while enhancing localization and translation processes, with the goal of reaching operational excellence through the implementation of impactful ELS, CMS and MDM technology.
Innovatum will be presenting a detailed review of the topic of EUDAMED based on published content and capabilities needed to support the required functionality.
Share this link with anyone you wish. We look forward to seeing you there!
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