21 CFR Part 11 Validation by Edwin Waldbusser

Website https://www.compliance2go.com | Edit Freely

Category Houston

Deadline: March 16, 2016 | Date: March 16, 2016

Venue/Country: Houston, U.S.A

Updated: 2016-02-09 18:57:09 (GMT+9)

Call For Papers - CFP

Wednesday March-16-2016 01:00 PM | 02:00 PM - EST

DESCRIPTION

This Webinar will explain what 21 CFR Part 11 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 will be explained.

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 21 CFR part 11 considers both.

The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained

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. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means.

Areas Covered in the Session:

Company certification

Records covered

Audit trails

Open /closed system access rules

Electronic signatures

Training requirements

Who will benefit: (Titles)

Engineering personnel

QA

IT

Management

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance