FDAnews Announces — Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections Webinar Dec. 9, 2020

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Turn inspection challenges into routine management tasks. Leading GXP consultant helps one gain control of documents.



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 GXP documentation. Poor communication with the vendors that generate the 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 the next inspection day doesn’t need to become a scavenger hunt. Create effective new SOPs for electronic document management or improve existing ones. It’s easy — when one knows how.

FDAnews has invited leading GXP (GCP/GLP/GMP) consultant, David Chesney, to help get control of the data. In 90 fast-paced minutes attendees will learn the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. Here’s just a taste of what one will discover:

  • The legal basis of FDA records access authority, including what FDA can’t access
  • Types of documents commonly requested during inspections
  • Problems and pitfalls to avoid
  • The Top 10 questions to ask about your archival process
  • What to do when documents are not in the general archives
  • The perils of emails as GXP documentation — and how to avoid them
  • If source data is electronic, how to provide access to the regulatory authority
  • True copies versus originals — what is deemed acceptable under GXP regulations?
  • The impact of the shift to real time electronic review of documents during inspections

Don’t go searching for the needle in a haystack on inspection day.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Organizing Data and Document Archives:
Finding a Needle in a Haystack for FDA Inspections
An FDAnews Webinar
Wednesday, Dec. 9, 2020 • 1:30 p.m. – 3:00 p.m. EST

$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/orgdatadocument
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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