Software Quality Regulatory Trends -- CS 150
Updated as of October 2008
Software Quality Assurance and Validation professionals operate in an ever changing regulatory environment. It can be difficult to find the time to monitor the US and international information to be aware of new regulations, guidance documents, and enforcement trends. This session will quickly bring you back up to the minute!
You will receive a quick refresher on the key US and international regulations and guidelines that apply to software quality. Then you will learn what software-related changes have recently been made to these documents and how these changes apply to your job. To help you focus your compliance activities, you will review a 3-year analysis of software-related FDA Warning Letters to see where the FDA focuses enforcement activities by software topic, system type, and industry. And finally, you will also see examples of 2008 FDA Warning Letters on common software quality and validation topics.
Topics:
- Key US and international regulations and guidelines regarding software quality
- Recent changes to these regulations and guidelines with discussion of the implications to software quality activities
- Trends in FDA Warning Letters related to software quality
- Analysis of FDA Warning Letters by software topic, system type, and predicate rule
- Examples of recent FDA Warning Letters pertaining to software quality and validation topics
Prerequisites: None
Text/Materials: Presentation materials, access to regulatory publications
Duration: 90 minutes, including time for Q&A
Presenter: Deb Bartel, MBA, PMP
Duration and Price: 1 hour, $225
|
Date |
Time |
Price* |
Register |
|
May 27, 2009 |
3:00 PM EDT / 2:00 PM CDT |
$225 |
|
| November 18, 2009 |
3:00 PM EDT / 2:00 PM CDT |
$225 |
|
*If you are a Power Subscriber of Validation Center™, you can attend this webinar for a discounted price. Please call us at 317-275-2870 to enroll.