Don Carter
Director of Validation at Amicus GMP Consulting
- Role
- Director of Validation at amicus GMP Consultants
- Location
- Lexington, SC, US
- LinkedIn followers
- 500 followers
About Don Carter
13+ years of experience in the pharmaceutical manufacturing industry
Experience
Director of Validation
Mar 2019 — Present · Lexington, SC, US
AMICUS is a consulting company providing efficient solutions to meet today\'s regulatory issues. We are a hands-on firm that believes in providing results beyond just “reports only.” At AMICUS, we provide a large range of services to FDA regulated compounders and manufacturers, all designed to meet our client’s specific needs. Services• GAP Analysis (503B Outsourcing Facilities, USP, & USP )• Process Optimization and Validation• Quality Systems Development• Quality Assurance Staff Augmentation• Equipment Commissioning and Qualification• Sterilization Validation (Dry-Heat and Moist Heat)• Temperature Mapping (Warehouse, Refrigeration, Incubators, etc.)• Due Diligence Audits• Consent Decree Remediation• Expert Witness Services
Skills
- Process Improvement
- Sales Operations
- Medical Devices
- Capa
- Continuous Improvement
- Process Engineering
- Validation
- Root Cause Analysis
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Microsoft Office
- Sales
- Team Building
- Manufacturing
- Microsoft Excel
- Quality Assurance
- Pharmaceutics
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