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