Spreadsheet Validation: Understanding and satisfying FDA requirements

Instructor: Alfonso Fuller
Product ID: 701194
  • Duration: 60 Min
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

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: Nov-2013

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

Read Frequently Asked Questions

Why Should You Attend:

Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.

Areas Covered in the Webinar:

  • Review of current FDA posture towards spreadsheets.
  • Review the relationship between "validation" and "part 11 compliance".
  • How do I determine which spreadsheets require validation?
  • Which spreadsheets are required to be compliant to 21 CFR Part 11 regulation?
  • Technical issues discussion.
  • Practical tips on gaining control over spreadsheets.
  • Practical tips on spreadsheet validation.

Who will Benefit:

Companies that manufacture, sell, or distribute Pharmaceuticals, Medical Devices, Biologics will benefit from this webinar, as well as vendors and suppliers who support them. Personnel who will benefit include:

  • Management responsible for operational and quality systems ("system owners")
  • Quality VPs, QA/QC Directors, Managers and personnel
  • IT / IS managers and personnel
  • Software validation and Software quality managers + personnel
  • Quality auditors and consultants charged with creating or evaluating validation and part 11 programs
  • Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
  • All business personnel who use spreadhseets that are subject to regulation

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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