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

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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.

Speaker
Instructor: Mercedes Massana
Product ID: 702117

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:

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:

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.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 75 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$499.00 Get Training CD Only
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