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Organizing Data and Document Archives Webinar on September 8, 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

Thursday, Sept. 8, 2022, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/organizing-data-and-document-archives-sept-2022

Pharmaceutical, medical device, biologics and diagnostics companies need to easily put their hands on the documents FDA investigators request.

In order to do this they need to create effective new SOPs for electronic document management or improve existing ones.

FDAnews has invited David L. Chesney, MSJ, a leading GXP (GCP/GLP/GMP) consultant to help manufacturers gain control of their data. In 90-minutes, attendees will learn the basics of developing best practices and SOPs that effectively turn inspections into routine management tasks. They will learn:


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

  • How to develop 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 count as GXP documentation

  • How to explain missing documents to investigators

  • If the source data is electronic, how to provide access to the regulatory authority

  • If the source data is paper that was scanned, what to do with the originals

Webinar Details

Organizing Data and Document Archives

Finding a Needle in a Haystack for FDA Inspections

An FDAnews Webinar

Thursday, Sept. 8, 2022, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/organizing-data-and-document-archives-sept-2022

Price:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/organizing-data-and-document-archives-sept-2022

By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:

WCG 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 WCG FDAnews’ newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations. Learn more at fdanews.com.

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