2011 - Learning from Recent Warning Letters Related to Computer Validation and Part 11

This seminar will provide more that 20 examples of recent FDA warning letters and give clear recommendations for corrective and preventive actions.

Why to attend:

In the last couple of years the FDA has discovered serious fraud related to security and integrity of electronic data. As a result FDA inspections look more than ever at computers, how they are validated and how companies comply with FDA's 21 CFR Part 11. This seminar will present more than 20 related warning letter examples together with detailed recommendations on how to avoid them.

Areas Covered in the Seminar:

* FDA inspections: Preparation, conducts, follow up
* The meaning of warning letters and 483 inspectional observations
* Learning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?”
* Data integrity and authenticity: FDA's new focus during inspections
* Examples of recent Part 11 related 483’s and Warning Letters
* Examples of recent 483’ and warning letters related to computer system validation ‘
* Most obvious reasons for deviations
* Responding to 483's to avoid warning letters: going through case studies
* Writing corrective AND preventive action plans as follow up to 483's
* Using internal audits to prepare yourself for Part 11 related FDA inspections?
* Strategies and tools for compliant Part 11 implementation
* The future of Part 11 and computer system validation

Date: October 20,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide oder USA

Who should attend

* Everybody using computers in FDA regulated environments
* IT manager and staff
* QA managers and personnel
* Regulatory affairs
* Training departments
* Consultants
* Validation specialists

Weblink: http://www.labcompliance.com/seminars/audio/277/de...

Presenter: Dr. Ludwig Huber