Using an IQ / OQ / PQ Approach to Validating Medical Device Software

Duration: 60 Minutes
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
Medical Device Compliance
Instructor: Mercedes Massana
Product ID: 501258
Objectives of the Presentation
  • Development of software test plans
  • How to apply IQ / OQ and PQ techniques to software
  • Risk based software testing
  • How does Software Validation relate to Design Validation?
  • Typical software tests
  • What is the appropriate sample size for software testing?
  • Software issue tracking
  • How to address open issues when releasing software
Why Should you Attend
Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software. This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.

Who can Benefit
This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:
  • Systems Engineers
  • Software testers
  • Test Engineers
  • Quality System Auditors
  • Engineering Managers and personnel
  • Regulatory Affairs
  • Software Vendors
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Systems Engineering, Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.
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