Early Bird Pricing Ends Friday, September 22, 2023!
AGENDA
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.
