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Seasoned professional providing Business Analysis, Validation, and Quality Assurance services to the pharmaceutical, medical devices, blood, and Third Party Logistics industries for 25+ years. Expertise in delivering solutions to your business problems in the areas of: -Validation of Computerized Systems, Facilities, Equipment, Transportation Systems -IT Governance & Quality Risk Mitigation -Regulatory Quality and Compliance (Pharma) including Risk Analysis and Management strategies -Enterprise Analysis / Business Analysis & Project Management -Audit Defense and Compliance Auditing -Periodic Review and Data Integrity Gap Assessment -Integration of Validation with Quality Management Systems Specialized expertise in: Computer Systems Validation, eQMS implementations, and application of GUI-0069 Guidelines for environmental control of drugs during storage and transportation , USP <1079> Good Storage and Shipping Practices, and USP <1083> Good Distribution Practices—Supply Chain Integrity.
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