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Using an IQ / OQ / PQ Approach to Validating Medical Device Software
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
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.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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Ensure Compliance to FDA's Design Control Requirements by using Requirements Management Techniques Key Considerations in Verification & Validation of Medical Devices An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 Creating a Good Design History File (DHF) for Audit Success