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Publications and Presentations

Recent BPA Publications

• Stein, R. Timothy, The Computer System Risk Management and Validation Life Cycle, Paton Professional, 2006. The book is expected to be published in early spring of 2006.
  
  
• Stein, R. Timothy, Minimizing Failures of Purchased Computer Systems, Quality Digest, March 2005.

• Stein, R. Timothy, Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements. ComplianceOnline, FDA Compliance Webinar Series, August 15, 2006.
  
  
• Stein, R. Timothy, Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements. ComplianceOnline, FDA Compliance Webinar Series, March 8, 2006.
  

• Stein, R. Timothy, “Practical Methods for Complying with the ISO 13485 Software Validation Requirements,” Presentation made at a seminar titled: Effective Implementation of ISO 13485: 2003. April 22, 2005. The seminar was jointly sponsored by the Northern California Biomedical Discussion Group, and San Francisco Chapter of the Regulatory Affairs Professionals Society.
  
  
• Stein, R. Timothy, “Catching Up on Computer System Validation,” Northern California Biomedical Discussion Group, February 23, 2005.
  
  
• Stein, R. Timothy, “Review of the Part 11 Regulations and a Discussion of Issues,” Presented to the American Society for Quality, Software Task Group for the Silicon Valley Section, November 9, 2004.
  
  
• Stein, R. Timothy, “An Overview of the Validation of Product and Non-Product Software,” Presented at the West Coast Conference on Software Validation and Quality System, An Update on Software Validation and Regulations, June 24, 2004.
  
  
• Stein, R. Timothy, “Software Verification and Validation of Business Applications,” Presentation made to the San Francisco Chapter of the American Society of Quality, March 25, 2004.
  
  
• Stein, R. Timothy, “What’s New in ISO13485, and How to Deal with It,” Presentation made to the San Francisco Bay Area Biomedical Discussion Group, December 3, 2003.
  
  
• Stein, R. Timothy. “Lifecycle for Off-the Shelf Software Validation,” Presentation made at the 57th American Quality Congress, Sponsored by The American Society for Quality, Kansas City, May 19, 2003. (Both the presentation and paper were published in the Congress Proceedings.)
  
  
• Stein, R. Timothy. “Achieving Part 11 Compliance – Implications of the New Guidance Document. Presented at a seminar, “Practical and Compliant Electronic Records,” sponsored by The San Francisco Area ASQ Biomedical Discussion Group, April 23, 2003.
  
  
• Stein, R. Timothy. “Why We Need to Assume that All Software is Defective.” Presented at a seminar, “Putting Software Validation into Practice,” sponsored by The San Francisco Area ASQ Biomedical Discussion Group, October 23, 2002.
  
  
• Stein, R. Timothy. “A Process for Assuring Quality in and the Validation of Off-the-Shelf Software.” Presented at a seminar, “Putting Software Validation into Practice,” sponsored by The San Francisco Area ASQ Biomedical Discussion Group, October 23, 2002.
  
  
• Stein, R. Timothy. “Establishing a Computer System Validation Capability.” Presentation given at a Roundtable, “Software Validation,” sponsored by The San Francisco Area ASQ Biomedical Discussion Group, April 24, 2002.