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FDA Auditing of Computerized Systems
and Part 11
Monday, Tuesday and Wednesday (8:30
a.m. - 5:30 p.m.)
Hands-On Part 11 Training
From the Same Instructors Who
Trained the FDA
- September 21-23, 2009, St. Paul, MN
- March 22-24, 2010, Las Vegas, NV
Keep
your company safe from FDA’s stepped-up enforcement in two areas directly
impacted by Part 11
and computer systems validation:
- Data integrity, especially in clinical and
manufacturing environments, and
- Supplier quality assurance
Receive
expert advice from ex-FDA senior officials and industry authorities who
trained
FDA’s own field inspectors to investigate and interpret CSV and
21CFR Part 11 compliance.
You’ll learn:
- Which validation deliverables the FDA expects and
what they should contain
- Why lots of compliance dollars and resources are
wasted on ineffective or inadequate validation
- How to identify, document and report computerized
system validation deviations
- Top validation errors cited in FDA enforcement
actions
- Proactive steps to avoid CSV and Part 11 Form
483s and warning letters
- Part 11 rules for electronic records and
signatures
- Paper vs. electronic? Ensuring electronic data
correlates to paper records
- Key principles of computerized system validation
- Change control and configuration management
- Ensuring audit trails and secure data access and
transfer
- Evaluating software vendor compliance claims
- Current status of Part 11 – revisions, rewrite or
abandonment
- How to prepare for the FDA inspector – using a
simulated inspection with real-world scenarios
Course
Content:
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FDA and
Computerized System Validation
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Which
validation deliverables the FDA expects and what they should contain
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Why so many
compliance dollars and resources are wasted on ineffective or inadequate
validation
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How the FDA
defines a systems risk, plus mitigation strategies you can deploy
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FDA Guidance on
Part 11 Scope and Application
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Part 11 rules
for electronic records and signatures
o
Paper vs.
electronic? Ensuring electronic data correlates to paper records
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Why data
integrity is critical with or without Part 11
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Current status
of Part 11 – revisions, rewrite or abandonment?
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Computerized
System Development Model and Methods
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Proven
techniques for developing compliant software
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Change control
and configuration management
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Data and
information resources
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Key Principles
and Techniques for Computerized System Validation
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Five pillars
required for effective CSV, including: system management and monitoring,
system change management, vendor management and CSV methodology
management
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Keys to
maintaining your systems in a validated state
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How to
identify, document and report computerized system validation deviations
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Ensuring audit
trails and secure data access and transfer
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Applying CSV
to various types of systems, including legacy systems
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Evaluating
software vendor compliance claims
·
Regulatory
Enforcement – Overview and Recent Trends
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Top validation
errors cited in FDA enforcement actions
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Proactive
steps to avoid CSV and Part 11 Form 483s and warning letters
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Workshop:
Exercises and Simulated Inspection of Computerized System Development
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How to prepare
for the FDA inspector – using a simulated inspection with real-world
scenarios
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Learn how to
apply effective auditing techniques
To Register or Get More Details:
Email Cece Bland, Director of
Training and Information Services, at Info@EduQuest.net
or call +1 (301) 874-6031. Tuition is $2795 with discounts for
teams of 5 or more.
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