Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Thursday, September 19, 2013 from 10:00 AM to 11:15 AM (PDT)
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 Seminar:
- 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
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.