OVERVIEW

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.

FDA has set up regulations that address both data security and patient safety. We will show how FDA 21 CFR Part 11 compliance checklist considers both.

WHY SHOULD YOU ATTEND

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.

AREAS COVERED

• Origin of the FDA regulation and changes in interpretation

• Electronic records

• CFR electronic signature

• Data security

• Open, closed and hybrid systems

• Validation methods

• Risk analysis

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

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