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Antonette Mitterando
Experience:
2002-Present
Managing Member of Quality Alternatives |
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Quality Alternatives Architecture & Engineering, LLC, Lebanon, NJ
cGMP compliance consulting firm that provides regulatory consulting and technical consulting to clients engaged in pharmaceutical and foods design and manufacturing. |
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Audit and Review Installation Qualifications (IQ's), Operational Qualifications (OQ's) and Process Qualifications (PQ's), as generated by the client and client validation contractors, pre and post execution, in accordance with cGMP and FDA regulatory compliance. |
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Provide consultation to approach and best practices for validating pharmaceutical-manufacturing operations. Evaluate manufacturing equipment & processes, utility systems and equipment cleaning methods. |
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HVAC analysis, troubleshooting, corrective design and construction implementation for 3 story Office building. |
| USP water system IQ/OQ review, SOP generation |
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| 1991-2002 Project Diversity: |
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New 65 million tablet coating facility inclusive of a USP purified water system; an interim 8 coating pan suite with ovens requiring retrofit of an existing USP purified water system; |
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High Rise Warehouse HVAC and control systems to incorporate even air distribution and qualification using mean kinetic temperature mapping; |
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Remediation, replacement and qualification of manufacturing, QC and adjacent environmental Air Handler systems, control systems and miscellaneous process and support equipment. |
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Member of Quality Review Board evaluating Qualification Documents for compliance and ability to adequately challenge the system in question, accessing and approving all utility impacts of proposed and executed work for the manufacturing site for HVAC systems, packaging lines, and process utilities; helped to develop the Change Control System. |
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Addressed 483 responses for the HVAC and water systems. Presented to the FDA and answered all questions regarding the HVAC protocols for format and technical content. |
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$65M Class 100,000 GMP Tablet Coating Facility, including Process Scale "Pilot" Coating Suites in existing space. Design, Construction and Start-Up, through Qualification of HVAC systems, controls, Equipment, USP purified water systems. |
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$9M Class 100,000 GMP R&D Facility Upgrade, inclusive of Dust collection systems, dehumidifiers, bag-in, bag-out HEPA Air supply systems, and clean steam generation. |
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$17M Central chiller water plant with piping distribution designed for 12Tons, construction issues: permitting for construction within flood plain, adjacent to the maximum foreseeable loss building. |
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$8.2M Co-Gen facility with 1 yr schedule and location constraints. |
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$16M environmental project for site hydraulic control. |
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$4M well water collection treatment plant. |
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$840K design, implementation and qualification of new process train, based on research and scale-up data, for the production of the Pharmacologically Active Ingredient for a nasal spray utilizing minimal Freon, including distillation and absorption through a molecular sieve unit. |
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Installation of auxiliary systems such as vacuum systems for packaging lines and $1.85M Low Nox Burner installation. |
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| Education: |
M.B.A. Pharmaceutical Management, Fairleigh Dickinson University.
BS Mechanical Engineering, Rutgers College of Engineering. |
| Professional Licenses: |
Professional Engineer
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State of New Jersey
State of Pennsylvania
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Registered Architect |
State of New Jersey |
Professional
Societies: |
American Society of Heating and Refrigeration Engineers.
International Society of Pharmaceutical Engineering. |
Adjunct Professor:
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New Jersey Institute of Technology
Graduate Course: Validation and Regulatory Issues in the Phamaceutical Industry |
| Endorsements: |
Click here to view Endorsements. |
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