ComplianceOnline

The 6 Most Common Problems in FDA Software Validation and Verification

Instructor: David Nettleton
Product ID: 705582
  • 7
  • February 2018
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min

Live Online Training
February 07, Wednesday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$199.00
One Dial-in One Attendee
$429.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Why Should You Attend:

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

Areas Covered in the Webinar:

  • Which data and systems are subject to 21 CFR Part 11 and Annex 11
  • Why compliance makes good business sense.
  • Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
  • Requirements for local, SaaS, and cloud hosting
  • The 6 Most Common Problems in FDA Software Validation & Verification.
  • Strategies on how to avoid the most common problems.
  • Advice on successful validation project staffing.
  • Avoid 483 and Warning Letters

Who Will Benefit:

  • System owners - responsible for keeping individual systems in validation
  • Computer system users
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Validation specialists
  • Software quality reviewers
  • Consultants
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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