Mitigating risk is essential to the success of your pharmaceutical projects, product development, and post production. Risk assessment is a critical process for those under increased regulatory scrutiny. Get the latest information on risk management concepts and practices for the pharmaceutical industry and learn how to plan your organization's risk management process to ensure compliance.

Learn how to manage a process associated with the identification, analysis, evaluation, and control of different types of risk before production begins. Class discussions cover several methods of conducting risk analysis including predictions and determining approaches to reliability and safety analysis.

Risk Management and Analysis for Pharmaceuticals Objectives

• Understand the purpose, benefits, and objectives of a
  detailed plan for risk management and analysis.
• Apply basic concepts of risk management and analysis.
• Identify risks and approaches to their solutions.
• Understand regulatory requirements of risk analysis.
• Use available information to analyze risk.
• Identify hazards in risk analysis.
• Estimate and evaluate risks.
• Monitor and control risks.
• Interpret risk analysis reports.

• Basic concepts and process model overview
• ICH Q9 Approach to Risk Management
• FDA's risk-based approach to cGMP
• The 13-step process
• Meeting regulatory requirements for risks
• Quantitative and qualitative risk analysis
• Risk response planning
• Risk monitoring and control
• Risk reporting
• Maintaining a risk management file

Who Should Attend Risk Management and Analysis for Pharmaceuticals?
Great for team members and staff in research and development, quality assurance, manufacturing, regulatory affairs, and other cross-functional team members involved with pre- and post production of pharmaceutical products.

Combine this two-day program with our Understanding FDA's CGMP for Finished Pharmaceuticals.