Norm Baird

Norm Baird

Ottawa, Ontario, Canada
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Baird Radiopharmaceutical Consulting

About

Baird Radiopharmaceutical is a small Canadian Corporation. As a Senior Consultant in the…

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Experience

  • Baird Radiopharmaceutical Consulting

    Ottawa, Ontario, Canada

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    Halifax and Missouri

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    Ottawa, Ontario, Canada

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    Ottawa, Ontario, Canada BWXT-ITG

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    Ottawa Ontario

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    Ottawa, Halifax and Missouri University Research Reactor

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    Ottawa, Canada Area

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    Ottawa, Canada

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    Ottawa, Canada Area

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    Ottawa, Canada Area

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    Ottawa, Canada Area

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    Ottawa, Canada Area

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    Ottawa, Canada Area

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    Ottawa, Canada Area

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    Kingston Ontario

Education

  • University of Windsor Graphic

    University of Windsor

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    Microbiology, DNA Studies, Molecular Biology, Reasoning Skills, Technical Writing

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    Statistical Analysis, Process Mapping, Root Cause Analysis, FMEA

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    This was a semester course given by Ottawa University professor Kathryn Wright on Pharmaceutical Microbiology.

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    Advance Medical Laboratory Technologist Studies

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    Activities and Societies: Varsity Soccer Player

    Medical Microbiology, Biochemistry, Hematology, Immunohematology and Histology

    Margaret Mason Academic Award, Hematology St. Lawrence College

Licenses & Certifications

Volunteer Experience

  • Soccer Skills Development and Fitness Coach

    West Ottawa Soccer Club

    - 6 years 1 month

    I was a skills and fitness development coach for a high level girls soccer team at WOSC

Courses

  • ISO 13485 Medical Device Risk Management

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  • Lean Sigma Greenbelt Course

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  • Medical Device Design Controls

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  • Medical Device Design Controls December 2018

    EduQuest

  • Medical Device Risk Management Course December 2018

    EduQuest

  • Minitab Statistical Tools for FDA Process Validation

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  • PDA Sterilization Course 2014

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Projects

  • Hot Cell Concept Design Boston Scientific

  • Hot Cell Concept Design ABK Biomedical

  • Mo-99/Tc-99m Generator Project BWXT Medical

  • Medical Device and Hot Cell Facility ABK Biomedical

    - Present

  • Mass Calculator Spreadsheet Design, Medical Device Release

    I am currently responsible for the design, validation and implementation of a spreadsheet application for Medical Device Mass and Radioactivity measurement.

  • Medical Device Terminal Sterilization Project

    My team and I designed, built, commissioned and qualified a terminal sterilizer and terminal process for an interventional medical device. This includes a design of a regulatory compliant steam sterilization process, biological challenges, thermal transfer measurements as. nd complete equipment IOPQ

  • Pharmaceutical and Medical Device Sterilizer Project, Components/Equipment

    My team and I were responsible for scoping, purchasing, and qualifying a set of terminal sterilizers for Pharmaceutical and medical Device component processing. This includes MVP, IOPQ, SOP, and all implementation/training.

  • Medical Device Manufacturing Facility

    My team and I were responsible for retrofitting and validating a Radioactive Medical Device Manufacturing Facility to meet ISO and Regulatory standards. This included all equipment and facility install, IOPQ and Process Validations, MVPs and other documentation. The facility was then successfully approved by the FDA for manufacture of the device. This was the second of three successful facility installs and qualifications.

  • Active Pharmaceutical Ingredient Container Project

    This project was to test and implement suitable containment vessels to ship radioactive active pharmaceutical ingredients (APIs). The project included chemical and radiological stability testing and pressure/containment testing.

  • Medical Device Manufacturing Facility

    In 2013 my team and I successfully installed and qualified all facilities and equipment for a Radioactive Medical Device Facility including safety devices, Master Validation Plans, Project Plans, Change controls, ISO-7 clean-room qualifications, IOPQs, environmental monitoring and process validations. The FDA approved the facility whcih has been used for commercial manufacture successfully and reliably since 2013.

  • Dose Calibrator Radiation Measurement Process and Gage R&R

    In response to an CAPA, my team and I performed a complete Gage R&R study on the radiation measurement of an interventional medical device. This included DOE, sample measurements, Minitab statistical analysis, report and corrective actions. These actions are in place today and control the accuracy of radiation measurement of a solid form radioactive microsphere.

  • Nuclear Hot Cell Isolator Design, Install Oct. 2019 MURR

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  • Radioembolic microsphere blending project

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  • Mcmaster Target Hot Cell and Automation Design Assist and Install

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    In collaboration with Promation Nuclear, RayAtom and McMaster University we are installing a system to expedite target material transfers at MNR

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