🎤   Carolyn Troiano       |  📅  August 30, 2023   |  🕒  11 AM Eastern Time US


DESCRIPTION:

Explore the application of the IEC 62304 standard to medical device software, while uncovering industry best practices for delivering reliable and secure software solutions for medical devices. Designed for professionals in FDA-regulated industries such as pharmaceuticals, medical devices, biologics, animal health, and tobacco, this webinar covers a wide range of relevant functions. Whether you work in research and development, manufacturing, quality control, distribution, clinical testing, management, adverse events management, or post-marketing surveillance, this session is tailored to your needs.

Attending this webinar is essential if you play a role in planning, executing, or managing the implementation of systems governed by FDA regulations. It is equally beneficial for individuals responsible for the maintenance or support of such systems. Stay ahead of compliance requirements, enhance your understanding of industry standards, and ensure the seamless operation of FDA-regulated systems by joining this highly informative session. 


Areas Covered In The Session:

  • Providing safe and effective medical devices is in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use software
  • This session will provide insight into the IEC 62304 standard as it is applied to medical device software
  • You will learn how to apply this standard to your own work processes
  • You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance

Who Should Attend:

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Quality Managers, Chemists, and Microbiologists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
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