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 regulated 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 development 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.