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Webinar Series | Auditing and Gap Assessments

Kymanox Knowledge Bar Webinar Series

Auditing and Gap Assessments

08MAR19 | 1:00 PM EST | FREE

Recorded Session and Slide Deck Available Upon Completion

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Product DescriptionIn an 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 hosted 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 was 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 (closed) or download the recorded session and/or the slide deck by adding to your cart below.

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

Date:Friday, March 8, 2019
Time:1:00 PM EST to 2:00 PM EST
Registration:  Audit Webinar Registration
Cost:FREE
Item:   Live Event Registration Webinar Recording Webinar Slide Deck
Purchase Price   $FREE $$9.90 $$199.00
Purchase   Closed (Available after 01SEP19)
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