How to validate software for SaaS-Cloud-Local Hosting


Tuesday, February 26, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 75 Minutes      

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One Dial-in One Attendee

Price: US$150.00


Corporate Live

Any number of participants

Price:US$290.00


Duration: 75 Minutes  
This webinar explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR), It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
David Nettleton   Product Id : 502313
  Instructor : David Nettleton

  More Trainings by this Expert


Overview:

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based approach to COTS software validation minimizes documentation and ensures efficient implementation of new and upgraded computer systems.

It details requirements for IT, SaaS, and cloud hosting. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This course will prepare you to perform a validation project, increase compliance, and demonstrate how to use risk management to improve system performance and promote process improvement.

Areas Covered in the Session:

  • Document a computer system validation project using easy to understand fill-in-the-blank templates
  • How to use the risk-based validation approach to lower costs and reduce validation documentation
  • Learn which documents the FDA expects to audit
  • Efficiently create validation documentation
  • Reduce testing by writing test cases that trace to elements of risk management
  • Requirements for SaaS and cloud hosting
  • Decrease resource requirements
  • Make documentation more manageable and understandable
  • Understand how SaaS and cloud hosting affect validation
  • Avoid 483s and Warning Letters
  • How to implement a computer system to gain maximum productivity
  • Use resources effectively to perform effective validation while avoiding doing too much
  • How to link requirements, specifications, risk management, and testing
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)

Who Will Benefit:
  • IT
  • QA
  • QC
  • Auditors
  • Laboratory Staff
  • Managers
  • GMP, GCP, GLP Professionals


Speaker Profile
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.




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