Innovatum Sponsors UDI Beyond the Basics Masterclass

As a contributing member of AIM, Innovatum invites you to take advantage of this free 2-hour UDI Masterclass we sponsored that was conducted by FDA and noted industry experts including Jay Crowley and Terrie Reed.

The Seminar recording is now available along with the session slide decks.
https://www.aim-na.org/udi-work-group.html

UDI SEMINAR TIMESTAMPS
1:41 – Unleashing the Potential of Medical Unique Device Identification | James Tcheng, Duke University Health
28:17 – Challenges with UDI Implementation | Jay Crowley, USDM and Dennis Black, BD
55:48 – UDI Panel – Vision and Reality | Patti Blessing, CAVU; Terrie Reed, Symmetric; Natalia Wilson, Arizona State University; Olga van Grol-Lawlor, Boston Scientific

Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for global implementation which presents its own specific challenges and opportunities. Adherence to specific regulatory specifications, both in labelling and packaging as well as data is a must, but in an increasingly competitive market, achieving compliance while maintaining a competitive edge and assuring ROI is paramount. This recorded Seminar highlights the state of urgency in the industry, addresses implementation challenges – plus helps you to maximize the ROI of your UDI implementation in the future, ensuring it continues to drive business value.


Considerations for End-To-End Labeling Implementation & Optimization (Video)

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.  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

 


Innovatum- Platinum Sponsor Of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference

9th Annual Q1 Device Diagnostic Labeling ConferenceSugar Hill, Georgia 09/08/2021

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.


Innovatum CEO Ardi Batmanghelidj: Solutions for Destination Labeling (Video)

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 CEO Ardi Batmanghelidj to Speak at Packaging & Labeling Regulations Webinar

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.