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Module One Agenda
Tuesday, September 19, 2023

*All Times Central US 

 8:00   ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
» Private & public text chat
» Interactive polling
» Tech check

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   ACHIEVING CAPA & LABELING CHANGE CONTROL PROCESS IMPROVEMENTS
• Practical application of label-specific CAPA strategies
• Outlining label edits & foreseeable risks in the QMS shift
• Integrating risk in the change control management plan
• Post-implementation: stability & effectiveness checks
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence
INTEGER

9:15   PRACTICAL CONSIDERATIONS IN PRECISE NEW RULE INTERPRETATION & RIPPLE EFFECT MANAGEMENT
• Impact of IVDR on the product’s intended use
• Integration of new requirements in an existing strategy
• Company culture influence in efficient change management
• Practical insight into rolling out the updated process
Irene Hsieh, Sr. Director of Regulatory Affairs & Clinical Affairs
EUROIMMUN

10:00   VIRTUAL NETWORKING & COFFEE BREAK

10:30   NAVIGATING REGULATORY REQUIREMENTS FOR MEDICAL DEVICE TRANSLATION: BEST PRACTICES FOR MANUFACTURERS & TRANSLATION COMPANIES
• Navigating continuously evolving regulatory requirements:
         » Language provisions including FDA & EU rules
         » MDR/IVDR localization/translations: Country/product specific/product status
         » Regulatory compliance strategy issues & the role/flexibility of an LSP
• Translation Processes to Ensure Quality & Compliance:
         » Having clean & high-quality translation assets in place
         » In-country review considerations to gain intensified efficiency
• Best practices in selecting a qualified LSP with necessary expertise
• Practical insight in maximizing relationships with LSPs
Michael Oettli, Founder & Managing Director & Vladimiros Stafylidis, Senior Compliance Program Manager
Nana Lachanidou, Director Supplier Services
NLG, A WELOCALIZE COMPANY

11:15   PANEL DISCUSSION: DEBATING METHODS TO STRENGTHEN POSTPONEMENT LABELING STRATEGIES
• Insight into common pitfalls & remediation strategies
• Pros/cons to adding to the label at point of distribution
• Necessary technology & use of cloud services
• In-house management vs outsourcing to 3rd parties
• Key lessons learned in late stage labeling execution
MODERATOR: John Kelser, LOFTWARE
PANELISTS: Roger Peterson, ARTHREX
Tara Baer, formerly with TAKEDA
Dawn Fowler, formerly with MASIMO

12:00   STREAMLINING GLOBAL LABEL DISTRIBUTION & PARTNERING WITH 3RD PARTIES
• Mapping out the channel to carve the optimal structure
• Controlling the full distribution channel vs use of 3rd parties
• 3rd party selection criteria & adherence to standards
• Implementation of LEAN processes to solidify the strategy
Tara Baer, Head of Global Labeling
FORMERLY WITH TAKEDA

12:45   MODULE ONE CONCLUSION

Module Two Agenda
Wenesday, September 20, 2023

*All Times Central US

8:00   ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
» Private & public text chat
» Interactive polling
» Tech check

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   NOTIFIED BODY INTERVIEW: CLARIFYING ONGOING GRAY AREAS
With differing interpretations from one body to the next, and the multitude of changes to labels and instructions for use in both the MDR and IVDR, professionals continue to seek clarity in practical aspects of compliance. Through questions coming directly from the participating audience, notified bodies will aim to provide insight assisting in finalizing tasks to fully confirm with the regulations.
INTERVIEWER:
Irene Hsieh, Sr. Director of Regulatory Affairs & Clinical Affairs
EUROIMMUN
INTERVIEWEES:
Jane Li, IVD Product Reviewer
GMED NORTH AMERICA
Adam True, Lead Auditor, MHS
TÜV SÜD

9:15 LABELING LESSONS LEARNED IN ACHIEVING SUCCESSFUL MDR CE MARKING
• Regulatory transition mapping & allocating resources
• Task prioritization & strategy execution
• NB comments leading to labeling updates
• Adherence to initial plans & course-corrections
• Practical learnings throughout the journey
Roger Peterson, Senior Manager, Global Labeling, Regulatory
ARTHREX

10:00   VIRTUAL NETWORKING & COFFEE BREAK

10:30   CENTRALIZED LABELING SYSTEM IMPLEMENTATION OR UPGRADE
With a plethora of benefits to offer, the ongoing shift towards the implementation of centralized data sources to optimize labeling operations remains at the forefront of manufacturers’ priorities. Whether the organization is in the midst of implementing a software solution to align content internally, or the system is already in place but demands for continuous upgrades to integrate growing volumes of data, insights into the practical aspects of initiating such a shift and leading the project to successful completion are pivotal to ensure a smooth transition to mastering the use of a centralized labeling system.
Chris Heckert, Senior Director of Labeling Solutions
NETWORK PARTNERS

11:15   INTERNATIONAL UDI PROGRAM FLEXIBILITY & ADAPTATION TO EVOLVING REQUIREMENTS
• Integrating traceability & UDI requirements from OUS markets
• Focus on EU specific demands & use of EUDAMED
• Addressing provision conflicts in program architecture
• Encountered challenges & lessons learned
Dawn Fowler, Former Director UDI/Master Data Management
MASIMO

12:00   Closing Remarks & Professional Education Course Conclusion

Who should attend:

Executives working within Medical Device and Diagnostic Corporations concerned with the appropriate development, design and delivery of labels and instructions for use, as well as meeting evolving regulatory guidance will be best suited to attend and take high value out of this meeting. Job titles for this meeting include:
• Labeling
• Regulatory Affairs
• Technical Writing
• Document Control
• Localization/Translation
• Quality Assurance/QMS