How to Validate Device & Computer Software

Patient risks, warning letters, and product recalls
Computer software validation is a challenging problem for device manufacturers and a common observation in 483 inspection reports, warning letters, and product recalls.

Validating software for its intended use and maintaining change control throughout the design and manufacturing process is hard. Those little bugs can cause big problems and fixing them on-the-fly is oh, so tempting. Especially during a clinical trial when the software is still under development.

Learning objective
This e-conference will point out common problems, give an overview of recent enforcement activity, and then present a comprehensive methodology for managing computer software validation and avoiding common traps.

Many types of software
There are many types of software found in the medical device industry, including:
[x] COTS (commercial off-the-shelf) applications.
[x] Custom in-house applications (databases and spreadsheets, web applications, etc.)
[x] Software embedded in medical devices.
[x] Software used to create or manufacture devices.
You will learn about common traps and take home a proven methodology that can be applied to validation plans that are either upcoming or already underway.

We will discuss
[x] A review of recent enforcement actions resulting from inappropriate computer system validations.
[x] The basics of computer softer validation and what is expected in any validation effort.
[x] Ofni Systems' methodology for how to create functional requirements, design specifications, and test cases.
[x] Specific problem issues including change control and risk assessment.
[x] New technologies for automated testing and electronic protocol execution.

Who should attend
[x] People monitoring studies on devices which have computer software. [x] Regulatory professionals who worry about software changes mid-study.
[x] Data managers and statisticians who work with data before and after a software change.
[x] Quality managers who are concerned with inspection and enforcement.
[x] Computer validation professionals working with medical devices.
[x] Executives who are planning their companies futures.

Presenter
Tyson M. Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. He is the creator of the FastVal Validation Document Generator and has worked on hundreds of client access programs to make them compliant. Mr. Mew regularly conducts training sessions for organizations to educate employees about the specific requirements of Part 11 and how to incorporate it into daily practice.

The purchase is $420 for OnDemand access and $470 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.