GCP Quality Assurance:
Risk Based
Data Driven
Operationally Aware
Quality Systems
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Quality Management System design and development
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"Lean SOP" development
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SOP gap assessments
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Veeva QualityVault and QMS implementation
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Quality, fraud, and scientific misconduct investigations
Audits and Inspections
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Qualification, in-process, and for-cause audits
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Computerized system audits and 21 CFR Part 11 assessment
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Inspection planning
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Mock inspections
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Storyboards
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Inspection coaching
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Situation room facilitation
Quality Management
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ICH E6 R2 quality risk management process implementation
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Quality, risk, and performance metrics design, development, and reporting
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Risk-based audit selection
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Risk-based monitoring support
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.
A syncline is a geological structure of folded, stratified rock. “Synclinical” is a play upon that term that emphasizes the collaborative, synergistic nature of clinical development.
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