Early Bird Pricing Ends Friday, September 22, 2023!




12:00 PT
Exhibitor



1:15 PT
Chairman's Welcome and Opening Remarks



1:30 - 2:30 PT
Panel Discussion: Compliance Intelligence - SaMD, CSA, EU MDR, 21 CFR 820, Annex 11

Kara Madsen, Vice President, Regulatory Affairs, Medtronic; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA; Daniel Walter, Policy Analyst, CDRH, U.S. FDA; Ravi Nabar, Senior Director Quality, Thermo Fisher Scientific; Ray Murphy, Fellow Engineer Global Software Quality, Boston Scientific



2:30 - 3:00 PT
CSV to CSA Transition Case Study - Risk, Validation and Critical Thinking Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic

Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic



3:00 - 3:30 PT
Exhibitor Showroom and Refreshment Break



3:30 - 4:30 PT
Digitalizing the Plant for Growth and The Art of Possible

Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations; Ryan Lindeman, Director of Operations Systems & Standards, and Mohamed Elsayed, Industrial Engineering Manager - Modeling & Simulation, Dexcom; David DeLuca, Director, Engineering & Validation, Compliance Group; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA



4:30 - 5:00 PT
Networking Cocktail Reception

Randy Horton, Chief Solutions Officer, Orthogonal.IO



5:15 PT
Networking Cocktail Reception



7:00 AM
Exhibitor Showroom Opens and Lite Breakfast



8:15 AM
Chairperson's Welcome and Opening Remarks



8:30 - 9:30 AM
Panel Discussion: Digital Transformation and Superintelligence Platforms in Medical Devices

Steven Thompson, Senior Director, Product Marketing, ValGenesis; Pat Baird, Regulatory Head of Global Software Standards, Philips; Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific



9:30 - 10:00 AM
Regulated Agile SDLC Transformation - Case Study

Dori Gonzalez-Acevedo, CEO, ProcellaRX



10:00 - 11:00 AM
Speed Training and Networking - Discover Innovative Processes and Technology



11:00 - 11:30 AM
Risk, Bias and Cybersecurity in AI Platforms

Pat Baird, Regulatory Head of Global Software Standards, Philips



11:30 - 12:00 PM
Implementation Use Cases and Validation of Artificial and Superintelligence Platforms

Steven Thompson, Senior Director, Product Marketing, ValGenesis



12:00 - 12:30 PM
Using AI in 3D Printing

Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific



12:30 - 1:00 PM
Networking Luncheon



1:00 - 2:00 PM
Panel Discussion: Use Cases in Compliance, Validation, Risk, QA - Bridging the Gap Between R&D, Quality, Post Approval and Rapid Technology Advancement

Stephen Cook, VP – Validation Quality & Compliance, Compliance Group; Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic; Ray Murphy, Fellow Engineer Global Software Quality, Boston Scientific



Select Between Knowledge Exchange Sessions



2:10 - 2:50 PM
A Case Study: Hollister’s Successful Transition from EU-MDD to EU-MDR with a Focus on Technical Documentation

Chris Latoz, Stability Manager, Hollister



2:10 - 2:50 PM
Validation Strategies for Software Ecosystems

Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson



3:00 - 3:30 PM
Exhibitor Showroom and Refreshment Break



Select Between Knowledge Exchange Sessions



3:30 - 5:00 PM
Design Control - Validation and Verification of Inputs

Alan Golden, Principal, Design Quality Consultants, LLC



3:30 - 5:00 PM
FMEA Templates and Managing Your Risk Ranking

David W. Vincent MPH, Ph.D., Chief Scientific Officer (CSO), VTI Lifesciences



5:00 PM
Close of Day 2



7:15 AM
Exhibitor Showroom Opens and Lite Breakfast



Select Between Knowledge Exchange Sessions



8:30 - 10:00 AM
Best Practices for a Medical Device Design Transfer

Robin Blankenbaker, Lifescience Portfolio Executive, Siemens Software



8:30 - 10:00 AM
Conducting Impact Assessments for Change Control

Randy Horton, Chief Solutions Officer, Orthogonal.IO



10:00 - 10:30 AM
Exhibitor Showroom and Refreshment Break



Select Between Knowledge Exchange Sessions



10:30 - 12:00 PM
Preparation and Survival of a EU MDR Audit

Sofia Abreu, Director, Global Regulatory Affairs, Hollister (Invited)



10:30 - 12:00 PM
MES - Implementation and Validation Case Study

Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson



12:00 - 1:00 PM
Networking Lunch



Select Between Knowledge Exchange Sessions



1:00 - 1:50 PM
Planning, Design History Files and Design Reviews

Alan Golden, Principal, Design Quality Consultants, LLC



1:00 - 1:50 PM
Using and Validating Azure, DevOps, Smart Sheets

Laurent Saugrin, Associate Director, Computer Software Assurance, CAI



Select Between Knowledge Exchange Sessions



2:00 - 2:30 PM
Implement a Risk Analysis and Management Program that Survives the Lifecycle

Connie Hetzler, Global Head – Validation, Alcon Laboratories (Invited)



2:00 - 2:30 PM
Qualifying Cloud Services as Part of Your Medical Device Quality System

Ed Hein, Senior Manager, Digital Product Excellence, LifeScan



2:30 - 3:00 PM
Exhibitor Showroom and Refreshment Break



Select Between Knowledge Exchange Sessions



3:00 - 3:40 PM
21 CFR Part 11 - How to Design and Comply

Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic



3:00 - 3:40 PM
Build a Successful Data Integrity Program

Kari Vecchione, Associate Director, Teva Pharmaceuticals (Invited)



Select Between Knowledge Exchange Sessions



2:55 - 3:25 PM
Align Your Unscripted Testing Strategy with CSA



2:55 - 3:25 PM
Shipping, Tracking and Packaging Validation

Connie Hetzler, Global Head – Validation, Alcon Laboratories (Invited)



4:30 PM
Close of Conference



Medical Device Validation, Technology, and Compliance University

Attend this collaborative event with rich content with two tracks addressing key issues for the design & development and manufacturing environments, including:

Compliance Intelligence – SaMD, CSA, EU MDR, 21 CFR 820, Annex 11
• Supplier Qualification and Management
• Bridging the Gap Between R&D and Manufacturing
• CSV to CSA Transition Case Study – Risk, Validation and Critical Thinking

Digital Transformation and Superintelligence Platforms in Medical Devices
• Implementation Use Cases and Validation of Artificial and Superintelligence Platforms
• Speed Training and Networking – Discover Innovative Processes and Technology
• Risk, Bias and Cybersecurity in AI Platforms
• Using AI in 3d Printing
• Stay Up to Speed on Emerging Diagnostics – Software as a Medical Device

Use Cases in Compliance, Validation, Risk, QA – The Interrelationships between Design/Development and Manufacturing
Design/Development Track:
• A Case Study – Hollister’s Successful Transition from EU-MDD to EU-MDR with Focus on Technical Documentation
• Design Control – Validation and Verification of Inputs
• Implement a Risk Analysis and Management Program that Survives the Lifecycle
• Preparation and Survival of a EU MDR Audit
• Planning, Design History Files and Design Reviews
• Best Practices for a Medical Device Design Transfer
• 21 CFR Part 11 – How to Design and Comply
• Align Your Unscripted Testing Strategy with CSA

Manufacturing Track:
• Validation Strategies for Software Ecosystems
• Build a Medical Device Data Integrity Program from the Ground Up
• Conducting Impact Assessments for Change Control
• Shipping, Tracking and Packaging Validation
• Using and Validating Azure, DevOps, Smart Sheets
• MES – Implementation and Validation Case Study
• Qualifying Cloud Services as Part of Your Medical Device Quality System
• FMEA Templates and Managing Your Risk Ranking

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.