2011 - Cost Effective Computer System Validation: Step-by-Step

This seminar will discuss FDA requirements for computer system validation and will go through all steps for implementation.

Why to attend:

The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. Using practical examples this seminar will provide all details, steps and documentation on how to validate computer systems for FDA compliance. Attendees will receive a toolkit with SOPs, Case Studies and Examples for easy implementation.

Areas Covered in the Seminar:

* US FDA and EU requirements and enforcement practices
* Learning from recent FDA 483's and warning letters
* Selecting the right validation model: qualification vs. verification
* Keep validation costs under control
* Eight fundamental steps for cost effective computer system validation
* Structure and example of a validation plan
* Justification and documentation of risk levels
* Example qualification document for suppliers of commercial systems
* Examples for requirement and functional specifications?
* Example for IQ/OQ/PQ protocols
* Validation of existing systems
Structure and example of a validation report
* Step-by-step case studies from laboratories and manufacturing for easy implementation
* Using prepared fill-in templates and examples for cost-effective implementation
* Most common pitfalls

Date: December 1,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide (oder USA, nicht Germany, fall das möglich ist)

Who should attend
* IT managers and system administrators
* QA managers and personnel
* QC and Lab managers
* Validation specialists
* Regulatory affairs
* Human resources (HR) managers and staff
* Training departments
* Documentation department
* Consultants

Weblink: http://www.labcompliance.com/seminars/audio/279/de...

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation