Good Documentation Practice (GDocP) for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Connection between GxP/GMP and document control

  • 23-January-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 90 Minutes

The Validation of Non Product Software

By: Thomas Bento ,Sr. Regulatory Consultant.

How to comply with 21 CFR Part 820.70(i) and effectively implement a software validation

  • 05-December-2019| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

Navigating the 510(k) process

By: Thomas Bento ,Sr. Regulatory Consultant.

Simplified defensible approach to a successful submission

  • 12-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes
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