FDA 21 CFR Part 11 for techies

Instructor: Alfonso Fuller
Product ID: 701518
Training Level: Intermediate
  • Duration: 90 Min
This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

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: Apr-2012

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

Email: customercare@complianceonline.com

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Course "FDA 21 CFR Part 11 for techies" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance by all companies. Most of the recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. On the other hand Software Quality, Validation and Compliance personnel often cannot explain in technical detail how to comply and often find it difficult to translate business requirements into technical design where as FDA inspectors are now being trained to evaluate software validation practices.

As compliance pressure rises, programmers, developers and system maintenance personnel need to determine exactly how to ensure 21 CFR part 11 compliance. Technical personnel need to understand how to weave part 11 compliance into computer systems regulated by FDA. This presentation will provide "under-the-hood' technical details of what is required and how to provide it.

Areas Covered in the seminar:

  • Outline of FDA regulatory scheme.
  • Review of FDA software validation regulations.
  • Why 21 CFR part 11 compliance is good business.
  • Review part 11 regulation.
  • Future of part 11 enforcement.
  • The biggest 21 CFR part 11 technical problems.
  • Communicating part 11 technical details with business, validation and software quality assurance.

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:
  • Technical implementation personnel
  • Technical maintenance personnel
  • System designers and integrators
  • System owners - responsible for keeping individual systems in validation
  • QA / QC managers, executives and personnel
  • Consultants
  • IT / IS managers and personnel

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.

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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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