Tim Fischer
Principal Partner at Great Solutions, Llc
Based in Charlotte, United States
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Seniority
C-Team
Department
General Business & Management
Location
Charlotte
Industry
IT Services and IT Consulting
Company size
3
Contact information
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t•••••••@gr8.global
Phone
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Background
About Tim Fischer
Our global services include a comprehensive assessment to help identify gaps and opportunities, a targeted project plan with timelines / milestones as well as an agreed upon schedule based on deliverables. We also offer add on services including a suite of software applications to help automate and validate critical compliance processes to assure long term success and audit readiness. Core Competencies include: 21 CFR 211 (GMP), 820 and ISO 13485 System Builds and Support GMP Training and Coaching FDA Inspection Preparation, War-rooms, Execution and Remediation Internal and 3rd Party Audit Preparation and Execution Computer System Selection, Support and Validation (IQ/OQ/PQ) Facility, Equipment and Process Commissioning and Validation Supplier / Material Qualification and Remediation Risk Assessment, Determination and Mitigation Adverse Event, Complaint Handling and Annual Product Review Change and Deviation Management Retain and Quarantine Requirements CAPA and Out of Specification Management DEA Regulations and Requirements Board of Pharmacy Warehouse Requirements
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