REMEDIATION PROJECTS

(March 2011 – September 2013)

Warning Letter / 483 Remediation

Global multi-million dollar In Vitro diagnostic Company in assays and assay instrument platforms as Global 3rd Party Risk Management Consultant – Train, mentor and implement risk management process compliant to ISO 14971 and modify Post-Market Notification process compliant to 21CFR Part 807 to support lifting FDA Warning Letter. (March 2011 – September 2013)

Project Lead, 483 remediation efforts in Risk Management

Author/Mentor

• Training content, assessment test development
• Delivered training on ISO 14971, fundamentals of FMEAs, and risk assessments to engineers, quality assurance personnel, and management
• Delivered classroom training and exercises on new risk management process
• Identified, trained, mentored and certified Risk Managers and Specialists at multiple global sites
• Cross functional project teams during design change and risk documentation development
• Review, red-line, and approve over a thousand risk documents including FMEAs (use, design, and process), risk assessments, risk management plans/reviews/reports, and system risk assessments in accordance with FDA obligated interim controls

Manage Resources and Timelines

• Global effort to sunset FDA obligated interim controls

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Project Team, 483 remediation efforts in Pre-Market Notification

Author/Mentor

• Process mapping of design change and pre-market notification processes
• Reviewed, red-lined, and approved new pre-market notification procedures and decision trees compliant to 21CFR Part 807 Subpart E/809/814/860/862/864/866
• Reviewed, red-lined and approved training content and assessment tests

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