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Finding a Needle in a Haystack for FDA Inspections Webinar on April 20, 2022

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FALLS CHURCH, Va. (PRWEB)

Organizing Data and Document Archives:

Finding a Needle in a Haystack for FDA Inspections

An FDAnews Webinar

Wednesday, April 20, 2022, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/organizing-data-and-document-archives-april22

Six words not to utter on FDA inspection day:

‘Now, where is that darn document?’

Paper documents. Emails as documentation. Poor communication with the vendors that generate data. Nonfunctional (or nonexistent) SOPs. Documents missing altogether. These and other documentation problems can create difficulties during inspections.

The next inspection day need not become scavenger hunt day. Learn how to create effective new SOPs for electronic document management or improve existing ones.

David L. Chesney, MSJ, principal and General Manager of DL Chesney Consulting, LLC, will further explain the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks:


  • How to determine which data are most likely to be requested during an inspection

  • Developing assessments to gauge the risk of not being able to find a document

  • The “Top 10” questions to ask about the archival process

  • What to do when documents are not in the general archives

  • When emails do count as GXP documentation

  • 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

  • And lots more besides!

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

Webinar Details:

Organizing Data and Document Archives:

Finding a Needle in a Haystack for FDA Inspections

An FDAnews Webinar

Wednesday, April 20, 2022 • 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/organizing-data-and-document-archives-april22

Tuition:

$287 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/organizing-data-and-document-archives-april22

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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