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FDA Audit - Bio/Pharmaceutical Course

Why should you attend?

Gain a deep understanding of the FDA Level III Pharmaceutical Inspectorate way of conducting bio/pharmaceutical inspections.  Enhance your expertise and engage with industry professionals. Join us to elevate your career in FDA auditing!

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Why learn about FDA Auditing of Bio/Pharmaceuticals?

FDA inspections provide the FDA insightful information about drug manufacturing operations.  This two-day course will provide industry auditors the chance to get up close and personal with regulator like thinking of how to conduct an FDA audit.  Students will get hands-on training on how to use inspection software to cite deficiencies using case studies to generate mock FDA-483 observations.

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Attend and you will learn

Attend this course to experience 2 days of interactive lectures, hands-on labs, and group workshops related FDA auditing policies and procedures.

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Industry-relevant classroom content:
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  • The FDA Investigation Manual

  • Case studies of drug CGMP deficiencies

  • The inspection software "ieQip" and Artificial Intelligence​

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Hands-on labs and workshops:
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  • ieQip inspection software and Artificial Intelligence

  • Team audit to generate mock FDA-483

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Who should attend

This course will benefit professionals looking for a better understanding of how FDA investigators cite effective observations which lead to regulatory actions such as warning letters, injunctions, consent decree, etc.

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We welcome those who are:

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  • Interested in conducting internal audit at manufacturing facilities or supplier audit

  • In expanding knowledge about FDA policies and procedures in conducting inspections

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Examples of past participants’ career paths:

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  • Quality assurance professionals interested in FDA audit

  • Bio/pharmaceutical manufacturing professionals interested in better understanding FDA auditing

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Examples of past participants' companies:

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  • Large and small biopharmaceutical

  • Contract research (CROs) and contract development and manufacturing (CDMOs)

  • Biopharmaceutical vendors, suppliers, and distributors

  • Regulatory professionals

  • Trainers and consultants in biopharmaceuticals

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Custom offerings for groups of 10 or more are available on request.  Contact info@wynngateconsulting.com for more information. 

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