FDAnews Announces Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections Webinar on April 20, 2022
Friday, April 8, 2022
Turn your inspection challenges into routine management tasks. Leading GXP consultant helps you gain control of your documents.
FALLS CHURCH, Va., April 6, 2022 /PRNewswire-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.
Media Contact
Michelle Butler, FDAnews, 703-538-7600, mbutler@fdanews.com
SOURCE FDAnews
|
|
|
|
|
 |
Asetek - Mandatory Notification of Trade | Jan 22, 2026
|
|
Tomorrowland Brings the Magic to Shanghai for a Spectacular First Indoor Edition in China | Jan 22, 2026
|
|
BC.GAME to Host "Stay Untamed" Night During Abu Dhabi's Packed Web3 Summit Week | Jan 22, 2026
|
|
Rent Manager Earned Best Real Estate Software Product Award and Multiple Review Badges from G2 Platform | Jan 22, 2026
|
|
Auburn University's Applied Research Institute Expands Advanced Manufacturing Capabilities with CF3D Enterprise Cell | Jan 22, 2026
|
|
California Divorce Mediation Center Unveils Modern Website Redesign | Jan 22, 2026
|
|
AMPERA ANNOUNCES LOCATION FOR GLOBAL HEADQUARTERS | Jan 22, 2026
|
|
Gemmy Alerts Customers: Fake Websites Target Holiday Decorators | Jan 22, 2026
|
|
Culture and tourism sectors thrive in Xiamen | Jan 22, 2026
|
|
AMPLIFY Named Finalist in Three Categories at the 2026 Golden Gavel Awards | Jan 22, 2026
|
|
|
