Glenn Wright

Glenn Wright

Indianapolis, Indiana, United States
2K followers 500+ connections

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About

30 years’ experience advancing quality in biotechnology and pharmaceutical…

Activity

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Experience & Education

  • PDA - Parenteral Drug Association

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Volunteer Experience

  • PDA - Parenteral Drug Association Graphic

    Chair, PDA Manufacturng Science and Operations Program Steering Committee

    PDA - Parenteral Drug Association

    - Present 9 years 7 months

    Chair of the PDA MSOP Steering Committee that brings industry leaders from Manufacturing Operations and Manufacturing Science together to advise PDA on areas that should be considered for added focus as well as areas where there are concerns or challenges that need to be addressed. Recommendations from the steering committee are provided to PDA leadership and staff for consideration.

  • PDA - Parenteral Drug Association Graphic

    Co-Chair PDA Task Force on Aging Facilities

    PDA - Parenteral Drug Association

    - Present 10 years 8 months

    Co-Chair PDA Task Force that has been working to understand industry challenges and approaches to modernizing aging facilities. The task force has held workshops and presented at PDA meeting and is working to finish a PDA Points to Consider document on this topic that is planned to be released by Q3 2017

  • PDA - Parenteral Drug Association Graphic

    Science Advisory Board Member

    PDA - Parenteral Drug Association

    - 6 years 11 months

    Member of the Science Advisory Board providing scientific oversight for PDA technical documents and working groups

  • PDA - Parenteral Drug Association Graphic

    Chair PDA 2015 Annual Meeting

    PDA - Parenteral Drug Association

    - 1 year

  • PDA - Parenteral Drug Association Graphic

    Co-Chair PDA Annual Meeting

    PDA - Parenteral Drug Association

    - 1 year 1 month

  • PQRI Graphic

    Chairman, PQRI Working Group on Post Approval Changes for Sterile Products

    PQRI

    - 1 year 9 months

    Chaired the PQRI working group with members from FDA, Industry and Academia in the development of a 116 page report on Post Approval Change reporting for sterile products. The report evaluated the level of risks associated with specific types of changes, the type of data sets that can be used to support the change, and the application of PAC reporting categories based on the level of risk.

  • PDA - Parenteral Drug Association Graphic

    PDA Science Advisory Board Member

    PDA - Parenteral Drug Association

    - 3 years 1 month

    Member of the Science Advisory Board providing scientific oversight for PDA technical documents and working groups

  • PQRI Graphic

    Chairman of the PQRI Working Group on Aseptic Processing

    PQRI

    - 4 months

    Chaired the PQRI working group comprised of members from Industry, FDA, and academia to develop a scientific based recommendation to several areas of concern reacted to aseptic processing. All recommendation were accepted by FDA and included in the FDA's guidance on Aseptic Processing,

  • Member of the Editorial Advisory Board

    Bioquality

    - 6 years 1 month

  • PDA - Parenteral Drug Association Graphic

    Co-Chair of the PDA Aseptic Processing Task Force

    PDA - Parenteral Drug Association

    - 1 year 10 months

    Worked with industry members to develop a scientifically based points to consider document on aseptic processing,

  • PDA - Parenteral Drug Association Graphic

    Founding President of the PDA Southern California Chapter

    PDA - Parenteral Drug Association

    - 2 years

  • PDA - Parenteral Drug Association Graphic

    Chairman, PDA/FDA 1996 Joint Conference

    PDA - Parenteral Drug Association

    - 8 months

Languages

  • English, Italian, Spanish (written)

    -

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