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Areas of Expertise

• Designs, develops, and implements strategies to assure cGMP/QSR compliance
• Prepares for and responds to inspections, with facility assessment and documentation, on-site support and advice during inspections, and strategic responses to Warning Letters and Consent Decree issues
• Develops Corrective Action and Preventive Action (CAPA) systems
• Provides third-party expert reviews of quality assurance and compliance status to support merger and acquisition decisions
• Designs and conducts assessments supporting legal proceedings, such as product liability or other disputes involving GMP/QSR compliant quality systems
• Identifies and prepares scientific spokespeople for litigation

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