Thomas McCullough
There is a difference between theory and practice. CORE provides project management, qualification and validation services.
- Role
- President at Core, A Unicon Company
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Thomas McCullough
Compliance, Verification and Validation Project Manager and DirectorMr. McCullough has presented his projects to the FDA and EU authority, participating as the owner\'s representative during their inspections with excellent outcomes. Mr. McCullough specializes in developing validation programs that are practical, value added and sustainable throughout system life cycles.Specialties: Project management, Strategic Planning, Change Management, Commissioning, Qualification and Validation planning, scheduling, work flow planning, coordination, document control, engineering data management, validation protocol and SOP preparation, validation protocol execution, summary reporting, regulatory submission document preparation.
Experience
President
Nov 2005 — Present
We provide Commissioning, Qualification, Validation, Project Management, Calibration and Supplemental Staffing Services to our Pharmaceutical and Biotechnology industry customers.
Education
Marywood University
Bachelor of Science (BS), Biology
1990 — 1993
Skills
- Engineering
- Project Planning
- Regulatory Affairs
- Lifesciences
- Cleaning Validation
- 21 Cfr Part 11
- Microbiology
- Medical Devices
- Capa
- Data Management
- Planning
- Biotechnology
- Quality Assurance
- Commissioning
- Automation
- Pharmaceutical Industry
- Sop
- Coordination
- Fda
- Budgeting
- Validation
- Computer System Validation
- Project Management
- Manufacturing
- Technology Transfer
- Pharmaceutics
- Scheduling
- Process Validation
- Budgets
- Change Control
- Quality Management
- Iso 13485
- Process Scheduler
- Quality System
- V&V
- Clinical Trials
- Document Management
- Process Simulation
- R&D
- Cgmp
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