Monday, Tuesday and Wednesday (8:30 a.m. - 5:30 p.m.)
Course Content:
FDA and Computerized
System Validation
Which validation
deliverables the FDA expects and what they should contain
Why so many
compliance dollars and resources are wasted on ineffective or inadequate
validation
How the FDA defines
a systems risk, plus mitigation strategies you can deploy
FDA Guidance on Part 11
Scope and Application
Part 11 rules for
electronic records and signatures
Paper vs.
electronic? Ensuring electronic data correlates to paper records
Why data integrity
is critical with or without Part 11
Current status of
Part 11 – revisions, rewrite or abandonment?
Computerized System
Development Model and Methods
Proven techniques
for developing compliant software
Change control and
configuration management
Data and information
resources
Key Principles and
Techniques for Computerized System Validation
Five pillars
required for effective CSV, including: system management and monitoring,
system change management, vendor management and CSV methodology
management
Keys to maintaining
your systems in a validated state
How to identify,
document and report computerized system validation deviations
Ensuring audit
trails and secure data access and transfer
Applying CSV to
various types of systems, including legacy systems
Evaluating software
vendor compliance claims
Regulatory Enforcement –
Overview and Recent Trends
Top validation
errors cited in FDA enforcement actions
Proactive steps to
avoid CSV and Part 11 Form 483s and warning letters
Workshop: Exercises and
Simulated Inspection of Computerized System Development
How to prepare for
the FDA inspector – using a simulated inspection with real-world
scenarios
