Jim brings over 30 years of industry experience and knowledge to to help you with your Quality and Compliance needs. Some areas of specialization include:

•  Process and program risk assessments and mitigation plans
• Management of cross-departmental project teams
• 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
• Document management and control
• Risk assessments of API sources and finished products
• Root cause analysis
• Product recall
• Supply Chain compliance (transportation, warehousing, and distribution)