ComplianceOnline

10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

Instructor: David Nettleton
Product ID: 701583
  • Duration: 60 Min
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Read Frequently Asked Questions

Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.

Why Should You Attend:

This webinar will explore proven techniques that reduce validation project time, often to one-third. Attendees will learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach will be detailed so that the specific documents for a validation project are understood. The webinar will detail requirements for IT, SaaS, and cloud hosting, while exploring methods to decrease resource requirements, and make documentation more manageable and understandable. This often cuts two-thirds of the costs. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.

Areas Covered in the Webinar:

  • Learn which documents the FDA expects to audit.
  • Proven techniques that reduce software costs and implementation times.
  • Increase corporate productivity and individual workforce member productivity.
  • Efficiently create validation documentation.
  • Requirements for SaaS and cloud hosting.
  • Decrease resource requirements.
  • Make documentation more manageable and understandable.
  • 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.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Who Will Benefit:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives
Instructor Profile:
David Nettleton

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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