Six words not to utter on FDA inspection day:
‘Now, where is that darn document?’
Paper documents unscanned. Naming conventions that don’t make sense. Emails as documentations. Poor communication with the vendors that generate your data. Non-functional (or non-existent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies.
But your next inspection day need not become scavenger hunt day. Create effective new SOPs for electronic document management, or improve existing ones. It’s easy — when you know how.
FDAnews has invited a leading GCP/GLP/GMP consultant to help you get control of your data. In 90 fast-paced minutes on your own desktop, you’ll learn the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. Here’s just a taste of what you and your staff will discover:
Your instructor, systems design expert Elizabeth Troll, has 25 years of experience helping companies organize data and documentation for FDA inspections. It’s a complex, detail-filled topic to be sure, but the interactive web format guarantees you’ll get all your questions answered. Just email them during the presentation.
Make sure your staff participates. There’s no limit on number of participants at one location. The price is the same whether it’s one, a dozen, a hundred or even more. Can you afford not to sign up?
Elizabeth Troll, a 25-year veteran of the pharmaceutical industry, focuses on quality management systems for GCP/GLP/GMP compliance worldwide. As principal of Troll Advisory Group LLC, she helps clients pass regulatory inspections via implementation of new systems, reconstruction of existing systems, and defense of systems designs during inspections.
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