Medical Device 5-Part Webinar Series

  • Overview
  • Details
Date(s): June 23, 2021 - August 25, 2021
Time: 1:00pm - 2:00pm EDT
Location: Online
Language: English

[Medical Device Webinar Series]

Assessing and Managing Risk in Medical Devices

A recently introduced set of medical device regulations calls for more thorough chemical testing for extractables and leachables and the establishment of robust risk-management processes aimed at enhancing patient safety. In complying with these new regulations, medical device manufacturers must carefully consider technologies and value-adding solutions that support an uninterrupted and accelerated route to market, including application of quality management software, improving data integrity, and leveraging modern instrumentation to gain greater insight into chemical and material characterization.

Join the discussion in this 5-part series and hear first-hand how industry experts have built effective and compliant risk-management workflows that help smooth the path of medical device product to market.

Why Attend:

  • Gain key insights into medical device regulations
  • Learn the importance and how to implement data integrity and compliance
  • Understand technologies and workflows for chemical characterization
  • Considerations for LC-MS method development and using chemical libraries


PART 1 | June 23, 2021 | 1:00-2:00 PM EDT

  • Achieving Successful Chemical Characterization of Medical Devices
  • Understand the updates to ISO guidances and, in particularly, ISO 10993-18:2020 on chemical characterization of medical device materials within a risk management process
  • Review of key areas of the guidance
  • Learn some of the challenges in achieving a successful study 
 PART 2 | July 14, 2021 | 1:00-2:00 PM EDT
  • Applying Data Integrity and 21CFR Part 11 on Complex Analytical Systems
  • Comprehend why data integrity and 21 CFR Part 11 compliance is important
  • Grasp concepts of ALCOA+ along with e-signatures, regular backup, and archiving activities
  • See how Abbott qualified and validated a Waters Empower Enterprise system
 PART 3 | July 28, 2021 | 1:00-2:00 PM EDT
  • Assessing and Mitigating Risk in Medical Devices: Applying ISO10993-18 in Characterizing for Extractables and Leachables
  • Understand how to address changes to ISO 10993-18 and the impact on E&L testing
  • How to deploy a compliant E&L workflow solution
  • Confidently identify known and unknown compounds using high-resolution mass spectrometry
 PART 4 | August 11, 2021 | 1:00-2:00 PM EDT
  • Strategies for Screening of Non-volatile Extractable and Leachable Compounds
  • Review of criteria needed for confident compound identification
  • Discussion on method development for general screening
  • Importance of a quality curated compound library to aid in the identification of unknown compounds
 PART 5 | August 25, 2021 | 1:00-2:00 PM EDT
  • Chemical Characterization of Medical Device Materials – An Analytical Laboratory Perspective
  • Real-world examples highlighting the chemical characterization of materials used in medical devices
  • Topics include:
    • Composition profiling of materials
    • Analysis of residual monomers, residual solvents, and other impurities
    • Characterization of extractables and leachables

To learn more about the sessions, presenters, and to register, click on the Register Now link below: