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2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

Speaker: David Nettleton
Date: 22 October, 2024 (Tuesday)
Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 120 Minutes

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OVERVIEW

This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and "wheel spinning." Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

This Seminar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

AREA COVERED

Which data and systems are subject to 21 CFR Part 11 and Annex 11
Why data integrity compliance makes good business sense
Requirements for local, SaaS, and cloud hosting
The 6 Most Common Problems in FDA Software Validation & Verification
Strategies on how to avoid the most common problems
Advice on successful validation project staffing
Learn how to avoid 483 and Warning Letters
Which software needs validation and which does not
Understand GAMP, qualification, and validation
Learn what the regulations mean, not just what they say
Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures

WHY SHOULD YOU ATTEND

Avoid the 6 most common problem associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.

WHO WILL BENEFIT?

System Owners - Responsible for Keeping Individual systems in Validation
Computer System Users
QA / QC Managers, Executives and Personnel
IT / IS Managers and Personnel
Validation Specialists
Laboratory Staff
Managers
GMP, GCP, GLP Professionals

SPEAKER

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.

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