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

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

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.

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