Medical Device Webinar Series Part 2: Applying Data Integrity and 21CFR Part 11 on Complex Analytical Systems
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 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
Who Should Attend:
- Scientists, chemists, and managers who have an interest in medical device regulations and focus on extractable/leachable testing
- Medical device manufacturers, CxOs, and suppliers focusing on medical device testing
Applying Data Integrity and 21CFR Part 11 on Complex Analytical Systems
Details on the standards from the different regulatory agencies (FDA, WHO, MHRA) driving these requirements and what these mean for quality records coming from analytical equipment/systems will be discussed. In addition, a discussion on ALCOA+ along with e-signatures, regular backup, and archiving activities are utilized to control and maintain a quality record will be highlighted as well. Lastly, examples of how Abbott qualified and validated a Waters Empower Enterprise system following both internal quality requirements and the standards set from the regulatory agencies that audit the company’s laboratories on an annual basis will be shared.
Presenter: Tony Miller (R&D Systems Specialist, Abbott)
Tony Miller holds a degree in biology with a minor in business and chemistry from Minnesota State University in Mankato, MN, USA.Hestarted his career at Minnesota Valley Test Labs (MVTL) and Envia Corp where he gained experience in using HPLC, UPLC, GC, ICP-MS, and ICS utilizing various CDS applications. Tony later joined St. Jude Medical where he was a system administrator on a number of lab applications including NuGenesis ELN/SDMS, Empower, MassHunter, Trios/Universal Analysis, and others. In 2017 Abbott acquired St. Jude Medical, and since then Tony currently leads organizational efforts that are focused on data integrity and Part 11 compliance with emphasis on ensuring compliance with regulatory standards and requirements
