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

Speaker

Instructor: Mercedes Massana
Product ID: 702117

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Feb-2016

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

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 :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method