Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts


Instructor: Angela Bazigos
Product ID: 703738

  • Duration: 90 Min
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
Last Recorded Date: Oct-2017


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)

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:

The comprehensive testing and control of computerized systems is first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, “the system is down.” A well designed validation project will provide assurance of business continuity, and consequently provide assurance of regulatory compliance.

This presentation will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well-controlled and successful computerized system validation.

Areas Covered in the Webinar:

  • Introduction, Historical Perspective, and Definitions
  • Computerized System Validation Master Plan
  • Validation Plan
  • Developer Assessment
  • Requirements, Design, and Configuration Specifications
  • Validation Testing
  • Procedures/Archival/Traceability
  • Validation Summary Report
  • Commissioning Memo
  • System Decommissioning/Retirement
  • Questions & Answers

Who Will Benefit:

  • Project/strategic management
  • Quality assurance staff
  • IT staff
  • Operations staff
  • Staff members involved with computerized system validation project planning, validation testing, system use, system support, and regulatory compliance of computerized systems
Instructor Profile:
Angela Bazigos

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley Inc

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.

Topic Background:

The basic concepts of computerized system validation originated in the 1960s with the Department of Defense and NASA. Validation of systems became a growing issue within the pharmaceutical industry during the late 1980s and early 1990s as the use of computerized technologies became commonplace in the research and manufacturing of drug products. The FDA issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s pharmaceutical environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.

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).




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