Software verification and validation failure is the third most often cited violation for medical devices by the FDA.
Fremont, CA: Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar on January 22 on the topic of Software Verification & Validation. This 90-minute session is aimed at imparting six enticing ways to improve your software verification skills.
The speaker, Lena Cordie, who brings over 20 years of quality and project management experience, will show how organizations can vet their software verification skills to ensure that they meet the set regulatory standards, which is a prerequisite for gaining approval for their products and to also gain consumer confidence.
Please visit https://www.compliance4all.com/control/w_product/~product_id=502319LIVE to enroll for this session.
The primacy of software verification and validation in a medical device can never be understated. Software verification and validation is that crucial seal on the medical device that assures that the product performs its set functions satisfactorily while meeting the specifications set out for it.
The importance of having the software verified and validated can be understood from the fact that this is the essential requirement that certifies that the product performs satisfactorily. Failure to meet verification and validation standards results in a substandard product, the surest recipe for disaster which could be of any magnitude. Software verification and validation failure is the third most often cited violation for medical devices by the FDA.
But software in medical devices being of a complex nature, the result of a complex interplay of not only elements within the device, but also many connecting devices and the users. This being its nature, it has to be designed in such a fashion that all these are in perfect sync with each other. While this is the primary challenge of developing software for medical devices; ensuring that the product also simultaneously meets regulatory requirements, set out in Part 11, which are not lax by any stretch of imagination, is another.
The goal of this extremely valuable session is to help participants overcome the fears and anxieties concerning software verification and validation. The speaker, Lena Cordie, will help participants ease the pain of meeting regulatory standards for software verification and validation.
She will get down to explaining the FDA 11-element documentation model that is most preferred in various applications by the FDA. She will include ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications in this discussion. Other areas into which she will delve include the use of FDA guidance’s, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, all of which are complemented with a learning of the ISO 14971/ICH Q9 Risk Management models and their real-world implementation.
The core of her teaching at this crucial webinar will be on offering understanding of six enticing ways to improve your software verification skills. These are:
- Developing and creating buy-in for a project validation plan
- Understanding what the FDA accepts as an appropriate documentation model
- Beyond just in-product software V&V – understanding FDA’s expectation for your testing software, ERP software and more
- When and how to use DQ, IQ, OQ, PQ or their equivalents
- How GAMP 4/5 requirements fit into your V&V planning and execution
- Detailing the FDA’s 11 key V&V documentation elements.
This webinar is of invaluable benefit to professionals in medical device industries who have to deal with some or another aspect of software verification and validation. These include Software Developers and Managers, Internal Auditors, Quality Assurance and Management Personnel, Software Quality Personnel, Software Test Personnel, Regulatory Affairs Management Personnel, IT Managers and System Administrators, and Software Validation Engineers.
Lena will cover the following areas at this webinar:
- FDA Quality System Requirements for software
- FDA guidelines on software verification and validation
- Smart software verification methods
- How to design smart validation tests
- How to conduct black box testing and white box testing to perform thorough validation.
About the speaker:
Lena Cordie, who works as a consultant at Qualitas Professional Services, LLC, is a senior quality and project management specialist who has more than two decades in the medical device industry. During these years, she has gained expertise of overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
She has been helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.
Read more at http://bit.ly/2soNVsY