Troy Fugate

Cincinnati, Ohio, United States Contact Info
9K followers 500+ connections

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About

The single most difficult issue faced by leaders is the incorporation of GMPs into their…

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Activity

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Experience & Education

  • Compliance Insight, Inc.

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Publications

Courses

  • FDA Law Practical Application for FDA

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Projects

  • Gene and Cell Therapy Commercialization

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  • PAI Preparations for FDA

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    Various projects for dozens of firms for PAI - pharmaceutical, medical device and cell therapy.

  • Company Board: GMP Discussions

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    Various events over the past several years to answer questions with company Boards. GMP issues, how to resolve FDA concerns, how to change the culture.

  • Good Supply Practices Implementation

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    Creation of new regulations for supply chain control. Training for FDA provided.

  • FDA Warning Letter Team

    What is the FDA Warning Letter Team?

    A team of energetic, practical and hands-on compliance specialists that will:

    • Assess your situation
    • Offer deliberate, methodical approaches to the response
    • Integrate with your team to execute upon actions
    • Restore your credibility with the FDA

    Other creators
    See project

  • Consent Decree Remediation

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    Direct oversight of FDA consent decree remediation

  • FDA Warning Letter Remediation

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    Resolution of FDA warning letter observations

  • Site construction oversight

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    From greenfield to re-construction activities. Provide compliance oversight. Presentation to FDA. Sterile to non-sterile operations. Lab construction. Packaging and warehousing construction.

  • Training for FDA

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    Various training activities at White Oak site. CDER, CBER, CDRH

Honors & Awards

  • Top 10 Compliance Provider

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  • Top 10 Pharmaceutical Service Provider

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  • Top 10 Pharmaceutical Compliance Solution Provider 2016

    Pharma Tech Outlook

    Compliance Insight selected for our Top 10 Pharmaceutical Compliance Solution Providers list has demonstrated a commitment to excellence and gained strong industry credibility.

    Using a practical and straight-forward approach over the past 16 years, Compliance Insight has successfully grown from the two founders to well over 50 colleagues who provide FDA compliance services nationally and internationally.

    With a corporate office in Ohio and branches in New Jersey and North…

    Compliance Insight selected for our Top 10 Pharmaceutical Compliance Solution Providers list has demonstrated a commitment to excellence and gained strong industry credibility.

    Using a practical and straight-forward approach over the past 16 years, Compliance Insight has successfully grown from the two founders to well over 50 colleagues who provide FDA compliance services nationally and internationally.

    With a corporate office in Ohio and branches in New Jersey and North Carolina, Compliance Insight actively engages and aligns with clients to be a part of their success.

Organizations

  • American Society of Gene and Cell Therapy

    Member

    - Present

    Society for the advancement of gene and cell therapy

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