Qualification of Contract Software Developers Based on Practical Experience

Live Webinar

  • 60 minutes

This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualification audit and final decision, will be explained. This process is based on the regulations and the authors experience in qualifying contract software developers. Contracts and Quality Agreements will be described in detail.

In this webinar join expert speaker Edwin Waldbusser, where he will explains the various regulatory requirements, and how to develop a software development contract and quality agreements.

Session Highlights:

  • Contract Software Developer risk determination method

  • Phases of selection

  • developing the audit; key stakeholder issues

  • Conducting the audit; key points to evaluate

  • Decision factors for selection; key practical points

  • Reasons for not using a numerical scorecard to make a decision

  • Key points for the contract and Quality Agreement

  • Change approval by both CSD and company

Why You Should Attend:

Regulatory agencies require that companies carefully select suppliers and contract software developers (CSD). They must follow a carefully planned and documented procedure. The responsibility for product quality and safety remains with the company. It cannot be delegated to the software developer.

Who Should Attend:

  • Computer system developers

  • Systems development engineers

  • QA/ QC

  • Lab Managers and Analysts

  • Production Managers

  • Engineering managers

*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it as per your convenience.

Edwin Waldbusser

Edwin Waldbusser

Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems.  He has been a consultant for the last 9 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom,Netherlands, Canada, Poland and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, and supplier qualification/ control.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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