Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements

Instructor: Tim Stein
Product ID: 700145
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

The FDA and ISO requirements for computer system validation and key methods for meeting those requirements.


Many regulated companies are still using unvalidated computer systems. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must transition to the 2003 version of 13485:2003.

Why Should You Attend:

Medical device companies must transition to the 2003 version of 13485.

This presentation will review the FDA and ISO requirements for computer system validation and describe methods for meeting those requirements. Emphasis is placed on applications currently used in production and quality systems, such as document control, ERP, complaint, and QA systems, and manufacturing execution systems.

What Attendees will Learn:

  • What I have to validate to meet FDA and ISO 13485 requirements
  • Why validation makes good business sense
  • The top 11 errors in computer system validation
  • What procedures are required and where to get them
  • What approaches you can use: prospective, concurrent, and retrospective
  • How to validate new systems with a prospective validation process
  • How to validate existing systems using a combination of concurrent and retrospective validation
  • What are the minimum deliverables that I must create

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical , and Biologics fields. The employees who will benefit include:

  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors

Instructor Profile:

Tim Stein, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.

Tim brings a rare combination of knowledge to computer system validation. He has in-depth knowledge of software engineering, computer system implementation, the regulatory requirements and guidance documents for software development and validation, and quality system requirements. In the late 80’s, as a quality manager with Tandem Computers, Tim was responsible of supporting 250 software development companies in improving the quality of their products. For the past twelve years, Tim has helped regulated companies establish compliant quality systems and validate computer systems. He also has help companies obtain the ability to validate systems by providing tools and training.

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