Aug 30 2010
The 6 Most Common Problems in FDA Software Validation & Verification : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com
The 6 Most Common Problems in FDA Software Validation & VerificationThis FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls. Training Options Training Duration = 69 Min
$299.00 Access Recorded Version Only
One Person – Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$500.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days
Instructor: Alfonso Fuller
Product ID: 701326
Training Level: Advanced
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Description
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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 seminar:
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 seminar 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, Esq. is the attorney-founder and President of Fuller Compliance, LLC, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of numerous 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.
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