ICH E.6 (R2)
Scope of and need for Gap Analysis
WEBINAR PROGRAM
• ICH E.6 R2 History, Changes and Scope
• Risk-based Quality Management
• Quality Tolerance Limits
• Risk-based Monitoring Plan
• Examples
• Gap Analysis
• Electronic Media Validation
• Data Collection and Reporting Procedures
• Computerized Systems, Validation
• Investigator Responsibilities
• Delegation of Tasks
• Essential Document
• How to Embrace GCPA
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