Good Documentation Practices to Support FDA Computer System Validation

As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

Carolyn Troiano | Duration:90 Minutes | Price: $150.00 View Details

21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Carolyn Troiano | Duration:90 Minutes | Price: $150.00 View Details

FDA's New Draft Guidance on Software and Device Changes and the 510(k)

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.

Carolyn Troiano | Duration:90 Minutes | Price: $150.00 View Details