Understanding the new International and FDA accepted Software Development Standard IEC 62304

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jun 10, 2010 End Date/Time: Jun 10, 2010
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Why Should You Attend:

Many firms feel that they are unsuccessful in their auditing of their software systems, and often find FDA or other auditing organizations repeatedly write them up for GMP violations. Repeated FDA 483's can lead to warning letters, seizures or even jail time. This presentation will cover the new FDA/IEC software development standard IEC 62304. We will address key process elements of the standard. Insight will be given into how FDA field staff will view your software development as it transitions to the IEC 62304 standard. Insight will also be given in terms of compliance risks to the company as it implements the standard.

Learning Objectives:

  • Learn key elements of the new FDA/IEC software development standard IEC 62304.

  • Learn about software development process and the IEC 62304 standard.

  • Learn what constitutes adequate compliance to the standard.

  • How IEC 62304 integrates RMA and CAPA issues.

  • How risk management fits into IEC 62304.

  • How to incorporate the IEC 62394 standard into their quality system.

Areas Covered in the Seminar :

  • Introduction.

  • 62304 standard transition tools.

  • Major FDA 483 points related to software compliance, and how firms may answer these objections.

  • Trends in FDA software warning letters as firms implement the standard.

  • Determining best practice for implementation.

  • How to train software engineers to the standard.

  • How IEC 62394 can prevent FDA 483 point issuance.

  • Questions & Answers.


Online Event
2600 E. Bayshore Road
Palo Alto
United States