SeerPharma Pty Ltd :: Pharmaceutical Consulting & Training

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Risk Management Services

Improve Quality Assurance, GxP Compliance and Validation outcomes through effective Risk
Management Strategies

Regulatory agencies have embraced the application of risk management across cGMP compliance, quality assurance, validation, product design / development and computerised systems.

Companies are now expected to justify their compliance position based on risk based strategies and management. SeerPharma risk management services focus on assessing and improving the effectiveness of quality assurance, optimising GxP and validation activities and adding real value to compliance programs. Our clients leverage vital resources, work on the right issues and optimise compliance budgets.

Corporate risk management strategies programs and assessments. ICH Q9 is now included in cGMPs in EU and FDA
Implement predictive, not reactive, risk management practices
Signifi cantly reduce time and costs in validation programs using ASTM E2500 approach
Ensure your QA programs add real value – work on the right issues
Conduct gap analysis to identify and mitigate real compliance risk
Use risk management as a strategic planning and control tool
Qualify CAPAs and Deviations using risk assessment
Track risk based mitigation strategies within a CAPA system

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