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:
GMP, GCP, GLP professionals
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.