REMEDIATION PROJECTS

(April 2015 – February 2017)

Warning Letter/483 Risk Management Remediation

Industry Leading Urology and Pelvic Health Company as Risk Management Consultant and Project Manager – Architect, train and implement quantitative risk management process and manage resources and timelines for urology products’ Risk Management Files to support lifting FDA Warning Letter.

­Project Lead of Quality Assurance Engineers (3), Quality Systems Engineers (2), Clinical (2), Technical Writers (2) and Training Designers (2) to create, release, train, and implement quantitative risk management process (April 2015 – December 2016)

Manage Resources and Timelines

• Project Task identification and management
• Project Task mapping, planning, and timeline management
• Project Task tracking and resource optimization
• Daily standup meeting communicating status to all organizational levels

Author/Mentor

• Risk Management procedure compliant to EN ISO14971:2012
• Causal Chain occurrence and probability calculations
• FMEA and Risk Assessment content development
• Risk Management Work instructions concept and content development
• Risk/Benefit Quantification concept and calculations
• Risk Acceptability Calculations (Individual and Overall)
• Risk Management Training content development
• Delivered Risk Management classroom training and exercises

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Project Lead, Risk Team consisting of Quality Engineers (5), R&D Engineers (2), Manufacturing Engineers (9) and Tech Writers (2) to establish Risk Management File compliant to EN 14971:2012 (January 2016 – February 2017)

Manage Resources and Timelines

• Project Task identification and management
• Project Task mapping, planning, and timeline management
• Project Task tracking and resource optimization
• Weekly standup meetings communicating status to all organizational levels

Mentor

• Anatomy of the Causal Chain
• Requirements mapping to Failure Modes
• FMEA linkages and ties to hazards and harms
• Risk assessment concepts and application
• Coding on complaint data fed to risk assessments
• Risk/Benefit Conclusions

Author

• Risk Management Plan
• FMEAs
• Risk Assessments
• Risk Management Report

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