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