Loading Purplepass...
21 CFR Part 11, Data Integrity, and Computer System Validation
Presented By ComplianceOnline
Tuesday, September 28th at 8:30am EST - Wednesday, September 29th, 2021
Online sale ends: 09/28/21 at 8:30am EST
online event
6201 America Center Drive Suite 240 San Jose, CA 95002, USA
San Jose, CA 95002
-= series =-
Buy Tickets
Buy Tickets

Learning Objectives:

  • Understand the difference between regulated and unregulated software in life sciences industries
  • Identify the major global regulatory documents governing regulated software
  • Become familiar with basic terms associated with regulated software and how they may differ from terms in other industries
  • Understand the objectives of global regulatory bodies in their oversight of regulated software
  • Understand the activities and elements of various regulated software lifecycle models
  • Identify required and recommended documentation to ensure defensible evidence of validation for intended use
  • Understand how to do effective impact analysis of changes to the software system
  • Understand the obligations of firms using software developed by third parties
  • Understand the obligations of firms using software hosted by third parties
  • Understand the importance of confidentiality, integrity, and availability (i.e. CIA) in the software lifecycle
  • Understand the importance of 21 CFR Part 11 to the software lifecycle and why it is often mistaken for the sum total of validation requirements
  • Gain insight into methods for defending validation evidence for regulated software systems
  • Learn about future trends in technical environments, regulatory frameworks, and enforcement

Areas Covered:

  • Current regulatory landscape (regulations, standards, guidance)
  • Basic terminology and concepts of regulated software lifecycles
  • Activity and documentation requirements
  • Change management
  • Cloud-hosted systems
  • Software-as-a-Service (SaaS)
  • Cybersecurity
  • Artificial Intelligence / Machine Learning (AI/ML)
  • Electronic records / electronic signatures
  • Audit / inspection defense
  • Enforcement trends

Who will benefit:

  • Regulatory Affairs Staff
  • Quality Assurance Staff
  • Managers
  • Directors
  • VPs
  • IT Managers
  • Manufacturing Managers
  • Clinical Affairs Staff
  • Software Vendors and Suppliers

Presented By

8:30am to 4:30pm
Doors open at 8:30am

All Ages

online event<br> 6201 America Center Drive Suite 240 San Jose, CA 95002, USA<br> San Jose, 95002



Monday, August 23rd

Past Event
Wednesday, August 18th

Past Event