Overview: This webinar is intended for executives and managers, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11. This webinar details how to assign team members, increase productivity, and lower costs.
Areas Covered in the Session:
What are the fundamentals of regulatory compliance?
Understand what the regulations mean, not just what they say.
How to avoid 483 and Warning Letters.
Which SOPs and validation documents are required?
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
How to lower costs, though reduction in resources, and reduction in documentation.
How to increase productivity by promoting efficient validation and use of computer systems.
Who Will Benefit:
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.
Live : $245.00
Corporate live : $495.00
Recorded : $295.00