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KENX Presents: GMP University
August 19, 2019 - August 21, 2019
Change Control
- Categorize Criticality
- Inspection Readiness
- Risk Management
- Impact Assessments
- Configuration Management
- Quality Management Software
- Best-in-Class Programs
Quality Risk Management
- ICH Q9
- Regulatory Intelligence
- Risk Ranking and Action Tables
- Conduct Risk Assessments
- Custom Tools
- Program Best Practices
- FMEA Training
- Human Factors
Internal Audits and FDA Inspections
- Preparation and Management
- Data Integrity Audit Plans
- Boost Compliance and Increase Value
- Risk-Based Auditing
- Conduct Mock Audits
- Writing Responses
