Rod Freeman
Site Quality Head, Novartis RLT
- Role
- Lecturer at Johns Hopkins University Advanced Academic Programs
- Location
- Oceanside, CA, US
- LinkedIn followers
- 500 followers
About Rod Freeman
Pharmaceutical Engineer and Quality Professional with more than 30 years experience in cell and gene therapy, viral vectors, pharmaceutical / biological operations and Quality Management Systems (QMS). Special expertise in Lean Manufacturing using the Danaher Business System (DBS), Validation, Quality Systems and Facilities Engineering. Exceptional expertise in Pharmaceutical Water Systems. Demonstrated ability to manage fast track projects and meet dead lines. Adept in setting and communicating technical concepts to diverse groups of people with various skill/ability levels.Specialties: Pharmaceutical Water System design, operation, maintenance, troubleshooting.Process, packaging, cleaning, utility, facility, and computer validation.Deviation and excursion investigation and root cause analysis (CAPA)Regulatory Inspections and Remediation Activities, DBS
Experience
Lecturer
Johns Hopkins University Advanced Academic Programs
Sep 2018 — Present
Adjunct Professor for the Johns Hopkins Krieger School of Arts and Science Advanced Academic Program teaching \"Introduction to GMP\" and \"International Regulatory Affairs\" for the Regulatory Science and Biotechnology programs.
Education
The Johns Hopkins University
Master of Science (MS), Regulatory Science
2013 — 2017
Virginia Tech
B.S., Chemical Engineering
1988 — 1992
Skills
- Technology Transfer
- Process Improvement
- Danaher Business System
- Engineering
- Biopharmaceuticals
- Biotechnology
- Process Engineering
- Regulatory Affairs
- Lifesciences
- Iso 13485
- Regulatory Requirements
- Pharmaceutical Industry
- Sop
- Fda
- Validation
- 21 Cfr Part 11
- Water Systems
- Quality System
- V&V
- Process Simulation
- Remediation
- Root Cause Analysis
- Troubleshooting
- Manufacturing
- Management
- Pharmaceutics
- Gxp
- Quality Auditing
- Aseptic Processing
- Cross-Functional Team Leadership
- Packaging
- Quality Assurance
- Cleaning Validation
- Gamp
- Medical Devices
- Capa
- Process Validation
- Lean Manufacturing
- Analytical Chemistry
- Quality Control
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