Organizing Data and Document Archives Finding a Needle in a Haystack for FDA Inspections

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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:

  • How to create unique naming conventions to handle masses of data
  • How to prioritize data that might be requested during an inspection
  • Pinpoint searching and how to do it
  • Developing assessments to gauge the risk of not being able to find a document
  • The “Top 10” questions to ask about your archival process
  • What to do when documents are not in the general archives
  • When emails do count as documentations
  • How to explain missing documents to investigators
  • If source data is electronic, how to provide access to the regulatory authority
  • If source data is paper that was scanned, what to do with the originals
  • Tips for dealing with more than one “original”
  • And lots more besides!

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?

  • QA/QC managers and staff
  • Document managers and staff
  • Regulatory affairs managers and staff
  • IT managers and staff

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.

Register now!

Date: Oct. 19 – Nov. 6, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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