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How to Build A World-Class Audit Team: The Key to Avoiding FDA Enforcement
Meet Susan Schniepp. She’ll show you how to avoid warning letters ... maybe forever.
The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud.
Not following SOPs. Data integrity and good documentation practices. Incomplete investigations. Ms. Schniepp, a QA expert and award-winning author with 35 years’ experience, walks you through the steps that counter such errors and teaches you:
Isn’t the prospect of avoiding warning letters and Forms 483 — possibly forever — worth 90 minutes of your time? Of course it is.
Susan Schniepp has over 35 years’ experience in Quality Assurance, serving in leadership roles at Searle, Abbott, Hospira, Allergy Laboratories and OsoBio Pharmaceuticals. A winner of the Parenteral Drug Assn. (PDA) Distinguished Service Award and Distinguished Author Award, Ms. Schniepp has served on PDA’s Board of Directors and chaired the PDA/FDA Joint Regulatory Affairs Conference as well as the Regulatory Affairs/Quality Advisory Board. Her book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process won the Distinguished Author Award in 2007 PDA. Reach her at firstname.lastname@example.org.
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