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

Instructor: Mercedes Massana
Product ID: 702117
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

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.

Areas Covered in the Webinar:

  • 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.

Who Will 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

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 twenty-five 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:  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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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