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Session 15: Responding to Inspection and Audit Findings
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- Preparation of responses to inspection and audit findings across commercial and research and development organizations
- Corrective and Preventive Action (CAPS) plans and effectiveness checks
- Responses accepted by regulators
- MHRA Inspection Findings Response Workshop
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