FDA Software Validation Self-Check - plan an effective Internal Audit program

Instructor: Alfonso Fuller
Product ID: 701519
Training Level: Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2014

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.

Why Should You Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?

Pharma, Biotech and Medical Device manufacturers are self-regulated with FDA oversight. By the time FDA come to your door, it may be too late to bring order to chaos. Companies have the responsibility to self audit to ensure compliance to GMP regulations. FDA inspectors are trained to know what to look for - you should too! Internal audits can be used for process improvement and leaning. Regular and diligent internal audits will help immunize you against severe penalties. Learn how to protect your internal audit records from FDA inspection.

Level the playing field by being prepared! Learn how to self-audit and ensure validation and software quality processes that will pass FDA scrutiny.Attendees should leave the seminar confident in being able to plan an effective internal audit program

Areas Covered in the Webinar:

  • Outline of FDA regulations as applied to software.
  • Review of FDA software validation requirements.
  • FDA inspection process.
  • How to 'design to succeed'.
  • Inspection preparation.
  • Documentation review.
  • Internal behavior review.

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:
  • Internal auditors
  • External auditors
  • Supplier auditors
  • Quality Assurance personnel and management
  • SQA - Software Quality personnel
  • Consultants
  • Business managers responsible for system compliance
  • IT / IS managers
  • Regulatory affairs personnel and management

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. Al 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 :
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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.

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