Turn inspection challenges into routine management tasks. Leading GXP consultant helps one gain control of documents.
FALLS CHURCH, Va., Nov. 23, 2020 /PRNewswire-PRWeb/ -- 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.
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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
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By phone: 888.838.5578 or 703.538.7600
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Michelle Butler, FDAnews, 703.538.7600, email@example.com