Event:
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Risk-based Software Validation for Quality System software
and Medical Device Data Systems (MDDS)
- Hosted By:
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ComplianceOnline
- Start:
- Tuesday - Feb 26, 2013 10:00 AM
- End Time:
- Tuesday - Feb 26, 2013 11:30 AM
- Location:
- Online
- This medical device software validation webinar will provide you the information you need to establish as system for validating software under FDA’s Quality System Regulation/cGMP.
Why Should You Attend:
Under Medical Device cGMP, 21 CFR820.70 (i), software used in manufacturing or testing of medical devices or in the quality system must be validated for its intended use. 21 CFR 11, Electronic Records, Electronic Signatures, also has software validation requirements. Product software is required to be validated as part of design controls (21 CFR 820.30). The FDA has recently down-classed MDDS to Class I, but requires that these system still follow design controls, and thus software validation.
This 90-minute webinar on software validation will provide you the information you need to establish as system for validating software under FDA’s Quality System Regulation/cGMP. This includes validating any software used for manufacturing and testing of medical devices and used in your quality system. In addition it will cover the approaches to validating Medical Device Data Systems software. This approach to software validation is also applicable to software used under GLP, GCP, and cGMP. Information will be provided to make sure your software validation system meets FDA regulations and guidelines.
- Website:
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Visit the website for detail info