I bring 30 years of industry experience and expertise to support your Quality and Compliance needs. Throughout my career, I have worked with a diverse range of organizations, including start-ups, virtual companies, and large enterprises. My focus extends beyond just assisting companies who have commercialized products already on the market; I also specialize in helping organizations bridge the gap and successfully transition from the clinical stage to the commercial stage.

Some areas of work include:

• Process and program risk assessments and mitigation plans
• Development and implementation of Quality Systems
• Gap Assessments, Corrective Action Plans, and Quality Systems remediation
• Direct interaction on your behalf with FDA, Health Canada, ANVISA, and other regulatory agencies during inspections
• Supplier selection and qualification
• Quality oversight of contract manufacturers, packagers, and distributors
• Quality Agreements
• Batch record review and product release
• Management of cross-departmental project teams
• Document management and control
• Risk assessments of API sources and finished products
• Root cause analysis
• Product recall
• Supply Chain compliance (transportation, warehousing, and distribution)
• Cold Chain qualification and compliance
• Product complaint investigations
• Deviation investigations
• Corrective and Preventive Action (CAPA)
• Manufacturing and packaging validation
• Internal and external auditing
• Change Control management
• Product stability programs
• Tracking and trending of quality metrics