Electronic Records Compliance: A Risk-Based, Predicate Rule Approach
Agenda: Day One
I. Introduction to Electronic Records Compliance-
Clarify scope and application of Part 11
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What is the consensus of the regulated industry
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Explore the legal implications of electronic records and electronic discovery
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Identify the impact of FDA's re-evaluation of Part 11
Exercise: Examine and Discuss Recent Compliance Issues
II. Identify Applicable Requirements within the Predicate Rules
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Explain the link between Part 11 and the predicate rule
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Identify record requirements in the predicate rules
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Identify requirements for predicate rule records that are electronic
Exercise: Examine Relationship between Part 11 and the Predicate Rules in a Warning Letter
III. Illustrate Risk Analysis Techniques
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Examine process and alternatives
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Identify hazards
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Quantify consequences and probabilities
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Determine alternatives and risk value
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Evaluate impact of FDA regulations
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Develop controls to reduce probability and consequences of hazards
Exercise: Apply Risk Analysis Techniques to Hypothetical Scenario
IV. Apply Risk Management to Computer and Software Systems
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Examine electronic record hazards
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Identify applicable FDA guidance
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Use risk-based tools for software validation
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Develop controls to mitigate hazards
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Document residual risk
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.