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3 Aspects of Labeling and Packaging Regulations
September 23, 2020 @ 10:00 am - 12:00 pm$10 – $25
Subject Matter Experts provide Regulatory Insight into Labeling and Packaging
WW insights into eIFU, CAPA for Packaging, UDI and MDR
Webinar, September 23, 10am-12pm
2hrs towards your RAC certification.
Subject Matter Expert’s address perspectives on regulatory issues related to labeling and packaging.
Project Managers: Karen Greene, Piet Lesage
10:05-10:40: The regulatory requirements for implementing eIFU
10:40-11:15: Packaging and CAPA: Interpreting regulations as it relates to package engineering through the lens of CAPA, and the guidance from applying DMAIC methodologies.
11:15-11:50: EU MDR, Eudamed and Associated Requirements as They Relate to Labeling Challenges
11:50-12:00: Final questions and wrap-up.
The regulatory requirements for implementing eIFU
Many manufacturers are investigating the possibility of replacing their paper “Instructions For Use” by an electronic alternative “eIFU” available over the Internet. Such a web-based solution has many advantages, but it is challenging to comply with all regulatory requirements and its impact on internal processes.
Mr. Maurizio Suppo, Ph.D., will introduce you to the applicable regulations.
Packaging and CAPA: Interpreting regulations as they relate to package engineering through the lens of CAPA, and the guidance from applying DMAIC methodologies.
This presentation will utilize real cases as the audience takes a journey through DMAIC methodology as it relates to CAPA and subsequently through each CAPA phase (Investigation, Implementation, and Control) activities. The presentation will touch base on key definitions, how to properly define and scope a CAPA, as well as how to utilize various root cause analysis tools and apply them to packaging corrective action and/or preventative actions. The presentation will also provide perspective demonstrating how packaging fits within a medical device manufacturers quality management system.
Mr. Elon Goldbaum, will walk you through the process.
EU MDR, Eudamed and Associated Requirements as They Relate to Labeling Challenges
The EU MDR, Eudamed and their associated requirements present some unique challenges for labeling. 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.
Mr. Ardi Batmanghelidj, will discuss UDI-MDR requirements.
Maurizio Suppo, Ph.D., Co-owner and Vice-President at Qarad B.V.
Mr. Maurizio Suppo obtained his Ph.D. in Molecular Biology from the University of Turin. He held executive positions at several world-renowned IVD companies (Becton Dickenson, Dade Behring, Siemens Healthcare) and was director of the European Diagnostic Manufacturers Association (EDMA).
Maurizio joined Qarad in 2012 and became co-owner in 2016.
Elon Goldbaum, Sr. Director of Packaging Engineering at Network Partners.
As Sr. Director of Packaging Engineering, Elon (Lon) brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.
Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibility, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding CAPA systems. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
Ardi Batmanghelidj, President & CEO at Innovatum, Inc.
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.
Government and Student Members: $10
Non-Members: $100, includes a one-year membership.
Government and Student Non-Members: $45, includes a one-year membership.
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.
Certificates of attendance will be emailed within a week of the event.
Registration deadline is September 22, 10am
OCRA’s non-profit Federal Tax ID# 33-0630455
Find the flyer here.
If you have any questions or require additional information, email OCRA Program Chair ([email protected]).