21 CFR Part 11 Compliance

This training program 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.

Why Should You Attend:

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s 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, wouldn’t encourage many to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will deconstruct the confusion over the original FDA regulation and its subsequent selective enforcement will be explained.

Areas Covered in the Webinar:

Company certification to FDA

Records covered

Audit trails

Open/ closed system access rules

Electronic signatures

Training requirements

Who Will Benefit:

Engineering personnel

QA

IT

Management

Instructor Profile:

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 areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/21-cfr-part-11-compliance-electronic-signatures-and-electronic-records-webinar-training-704481-prdw?channel=sciencedz