GxP Computer System Validation, The investigator's Point of View

Overview:

The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.

Areas Covered in the Session:

• Which data and systems require validation and which do not?
• What the regulations mean, not just what they say.
• Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, and electronic signatures.
• SOPs required for compliance. 
• How to avoid 483 and Warning Letters.
• What has to be qualified? 
• What has to be validated? Developer vs. user validation models. 
• Maintain compliance with change control for revalidation.

Who Will Benefit:

• IT
• QA
• QC
• Laboratory staff
• Managers
• GMP, GCP, GLP professionals

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