The 6 Most Common Problems in FDA Software Validation and Verification

Speaker

Instructor: Alfonso Fuller
Product ID: 701326
Training Level: Advanced

Location
  • Duration: 60 Min
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.
RECORDED TRAINING
Last Recorded Date: Feb-2015

 

$279.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$479.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

  • FDA inspectors are now being trained to evaluate software validation practices.
  • Increasing use of 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'.
  • A third of recent warning letters included citations with respect to improper or ineffective validation.

Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding six common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.

Areas Covered in the Webinar:

  • Outline of FDA regulations as applied to software.
  • Review of FDA software validation requirements.
  • Why validation makes good business sense.
  • 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.

Who Will Benefit:

This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
  • System owners - responsible for keeping individual systems in validation
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Validation specialists
  • Software quality reviewers
  • Consultants

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Mr. Fuller is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2021 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method