Simplifying Global Compliance
How to Build A World-Class Audit Team - Webinar Recording/Transcript
| Quantity Discounts | 1 - 2 $287.00 | 3 - 4 $258.00 | 5 - 6 $244.00 | 7 - 9 $230.00 | 10 - 9999 $215.00 |
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.