How to Build A World-Class Audit Team - Webinar Recording/Transcript

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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:

  • Elements of an effective audit program, including naming members who not only know SOPs, but know whether you’re really following them
  • Better utilizing internal audit observations to drive continual improvement and remediate shortcomings before it’s too late
  • Qualities of effective auditors and team leaders — and how to spot them
  • Good documentation practices — the best prevention against warning letters and other regulatory headaches
  • And much more!

Isn’t the prospect of avoiding warning letters and Forms 483 — possibly forever — worth 90 minutes of your time? Of course it is.

  • Auditing/compliance
  • Pharma/device manufacturing/GMP
  • QA/QC/QR
  • Production managers/supervisors
  • Process development staff
  • Trainers
  • Regulatory affairs
  • Executive suite
  • General/corporate counsel
  • Personnel new to the industry

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 s.schniepp@rcainc.com.