Overview:
This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will...
Overview:
1. This course will teach you how to reduce software validation costs by as much as two thirds.
2. It details all the requirements for 21 CFR Part 11...
Overview:
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions....
Overview:
This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate...
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