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Dennis Moore
Beverly Hills, California
FDA Expert
Management of FDA Pre-Approval and Corrective action and remediation plans for Quality System inspections
Warning Letters
FDA 483s and Part 11 compliance
Regulatory strategic planning
Food Sanitation compliance
510(k) / PMA submissions
Combination product compliance
Integration of ISO 9001
FDA/State relations
OOS to CAPA migrations
Development of CMC sections for NDAs
Drug firm Design Control training
Promotion and labeling of medical device for FDA compliance
Participation in due diligence regulatory reviews
ISO 13485
21 CFR 820 Quality Systems
GxP / GLP Auditing and training
Medical device design control
Development and implementation of risk-based quality systems
Complaint management and failure investigation
Food processing review
Process development and validation
Development of Part 11 software quality assurance programs
Development of documentation and change control programs
Technology transfer and scale-up
Process monitoring programs
Environmental control and monitoring
Development of OOS programs
Strategic planning for PMA modules
Complete redesign of CAPA systems
Food HACCP program development
Mock QSIT/ISO 13485 FDA/ISO audits(12 performed in 2013-2014)
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