Webinar On Computer System Validation: Step-by-Step

Description :

The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.

For easy implementation, attendees will receive

SOP: Validation of Commercial Off-the-Shelf Computer Systems

SOP: Development and Maintenance of Test Scripts for Software and Computer Systems

Checklist: Using computers in FDA regulated environments

Areas Covered in the Session :

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

Eight fundamental steps for 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 protocols

OQ test protocols: development, execution, approval - examples

Documentation of ongoing performance

Validation of existing systems

Structure and example of a validation report

Step-by-step case studies from laboratories and manufacturing for easy implementation

Who Will Benefit:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are:

IT managers and system administrators

QA managers and personnel

QC Lab managers and üersonnel

Validation specialists

Regulatory affairs

Training departments

Documentation department

Consultants