How to Prepare for FDA BIMO Inspections 2012

Key Topics

• GLP requirements
• FDA regulations and guidance on GLP and GCP
• BIMO program and inspection
• GCP requirements
• Clinical investigators (CI)
• How to communicate during and after BIMO inspection
• Sponsors and Monitors
• Institutional review boards (IRBs)
• ICH-GCP guidelines
• Contract research organizations (CROs)
• Summary of ten (10) case studies
• ISO 14155

Who should Attend

VPs, CEOs, Attorneys, Compliance officers, Regulatory affairs (associates, specialists, managers, directors or VPs), Clinical affairs (associates, specialists, managers, directors or VPs), R&D (engineers, scientists, managers, directors or VPs), Quality assurance (associates, specialists, managers, directors or VPs), Consultants, CROs and Contractors/subcontractors.