2019 - Webinar on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records

OVERVIEW
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s at their next inspection. Our upcoming webinar discusses what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
The webinar covers the following key areas:
• Origin of the FDA regulation and changes in interpretation
• Electronic records
• CFR electronic signature
LEARNING OBJECTIVES
This webinar will explain what FDA 21 CFR Part 11 compliance is, why it is important to FDA regu-lated companies and how conformance to Part 11 differs from just having good IT security.
Procedures for controlling electronic signatures and electronic records as described in the FDA regulation will be explained.
WHO WILL BENEFIT
Engineering personnel
QA
IT
Management
Compliance Officers
Regulatory Affairs
Safety Manager
Document Control
Medical Affairs
SPEAKER
Edwin Waldbusser is a consultant retired from industry after 20 years in management of devel-opment of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 9 years.
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