• Kymanox Webinar Series: Auditing and Gap Assessments

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    Name: Kymanox Webinar Series: Auditing and Gap Assessments
    Date: March 8, 2019
    Time: 1:00 PM - 2:00 PM EST
    Event Description:
    In our effort to bring our Ideal Knowledge Transfer™ concept to life, the Kymanox team often hosts a series of live, interactive webinars to bring our experience and knowledge to others. On Friday, 08MAR19, at 1:00 PM EST, the Knowledge Bar will be hosting a 1-hour webinar covering Auditing and Gap Assessments.

    Webinar Overview:

    • 1-hour interactive webinar discussing the basics of auditing and gap assessments of CGMP facilities.
    • Explanations from resident subject matter expert as to what makes quality audits successful.
    • Real-life examples from audit war-room experiences used to illustrate best-in-class practices.
    • Presentation followed by a Q&A session to address specific questions, concerns, and comments.
    Presenting will be Erica Fadool, ASQ-CQA, Manager of Compliance at Kymanox. Erica has expertise in Quality Management Systems, Quality Control (QC), Analytical Method Validation and Transfer, Equipment Qualification, Six Sigma/Kata, Aseptic Process Simulation, Process Performance Qualification, Technology and Process Transfer, Commercial Startup, and Auditing. During her career, Erica has directly supported Food and Drug Administration (FDA) Pre-Approval Inspections (PAIs), bi-annual inspections, and Biologics License Application (BLA) submissions to FDA and the European Medicines Agency (EMA). She has performed Mock Pre- Approval Inspections for Medical Device and Small Molecule Drug manufacturers to ensure licensure approval by regulatory agencies. Erica has a Bachelor of Science Degree in Chemistry from North Carolina State University. She is a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) and is a certified Six Sigma Green Belt.

    Feel free to sign up at the link below to attend the live session or come back to this webpage after 08MAR19 to download the taped session.
    Webinar, your computer
    Date/Time Information:
    March 8, 1:00 - 2:00 p.m.
    The event schedule is as follows:
    • 1:00 PM - 1:45 PM - Auditing and Gap Assessments presentation
    • 1:45 PM - 2:00 PM - Q&A
    No cost to participate. Register here
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