The Clinical Device Group will present an e‑conference How to Validate Device and Computer Software on July 8, 2009 at 11:00 am Central. The e‑conference will be presented by Mr. Tyson Mew.
This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on validation for medical devices and computer software.
Learning Objective
The objective of this conference is:
- To review recent enforcement actions as a result of inappropriate computer system validations.
- To cover the basics of computer software validation and what is expected in any validation effort.
- To present our methodology for how we create functional requirements, design specifications and test cases.
- To educate users about specific hot spots, including Change Control and Risk Assessments.
- To discuss new technologies for automated testing and electronic protocol execution.
Compliance is Important
Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:
- COTS (Commercial Off-The-Shelf) applications
- Custom in-house applications (databases and spreadsheets, web apps, etc)
- Software embedded in medical devices
- Software used to create or manufacture devices
All of the above must be validated for intended use and be under strict change control. The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating.
Validation Solutions for Medical Device and Software
This presentation will provide a brief overview of recent enforcement activity to point out common problem areas, then a comprehensive methodology will be presented for how to manage CSV activities at your organization.
People attending this conference will learn about common CSV traps and take home a proven methodology that can be applied to any existing validation plans that are either upcoming or already underway.
The purpose of this presentation is to warn CSV professionals about common problem areas and to provide them with new tools and methodologies that they can apply in their own organization.
You will Receive
All people who attend this e-conference will receive:
- PowerPoint Slides
- An expert speaker
- A chance for Q & A
- CEUs & Certificate
Audience Suitability
This e-conference is suitable for:
- Clinical research professionals who design clinical trials
- Regulatory professionals who report clinical data
- Managers who sign-off on clinical trials
- Executives who are planning their companies futures
- Computer validation professionals working with medical devices
About Tyson Mew
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 the rule and how to incorporate it into daily practices. He is an active member of ISPE, DIA, SQA and the Triangle Part 11 PEERS Group.
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