Attend this collaborative event with rich content with two tracks addressing key issues for the design & development and manufacturing environments, including:
Compliance Intelligence β SaMD, CSA, EU MDR, 21 CFR 820, Annex 11
β’ Supplier Qualification and Management
β’ Bridging the Gap Between R&D and Manufacturing
β’ CSV to CSA Transition Case Study β Risk, Validation and Critical Thinking
Digital Transformation and Superintelligence Platforms in Medical Devices
β’ Implementation Use Cases and Validation of Artificial and Superintelligence Platforms
β’ Speed Training and Networking β Discover Innovative Processes and Technology
β’ Risk, Bias and Cybersecurity in AI Platforms
β’ Using AI in 3d Printing
β’ Stay Up to Speed on Emerging Diagnostics β Software as a Medical Device
Use Cases in Compliance, Validation, Risk, QA β The Interrelationships between Design/Development and Manufacturing
Design/Development Track:
β’ A Case Study β Hollisterβs Successful Transition from EU-MDD to EU-MDR with Focus on Technical Documentation
β’ Design Control β Validation and Verification of Inputs
β’ Implement a Risk Analysis and Management Program that Survives the Lifecycle
β’ Preparation and Survival of a EU MDR Audit
β’ Planning, Design History Files and Design Reviews
β’ Best Practices for a Medical Device Design Transfer
β’ 21 CFR Part 11 β How to Design and Comply
β’ Align Your Unscripted Testing Strategy with CSA
Manufacturing Track:
β’ Validation Strategies for Software Ecosystems
β’ Build a Medical Device Data Integrity Program from the Ground Up
β’ Conducting Impact Assessments for Change Control
β’ Shipping, Tracking and Packaging Validation
β’ Using and Validating Azure, DevOps, Smart Sheets
β’ MES β Implementation and Validation Case Study
β’ Qualifying Cloud Services as Part of Your Medical Device Quality System
β’ FMEA Templates and Managing Your Risk Ranking
Speakers:
π€ Khaled Moussally: EVP Quality β Clients & Regulatory Relations, Compliance Group Inc.