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Archiving GLP Records: How Archiving Makes or Breaks the Audit

Archiving GLP Records: How Archiving Makes or Breaks the Audit

Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
State: California
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: GLP Records, Archiving Practices, Laboratory Records, on-site review, archive structure, archive facility, in-house archiving, out-sourced archiving, citations, archiving process
Start Date of Conference:: 03-22-2012
End Date of Conference: 03-22-2012
Description of Conference: This webinar on archiving GLP records will discuss the options for managing large archiving facilities to small facilities with one-room archives. You will receive practical tips on how to correct mistakes that agencies have cited regarding archiving.

Why Should You Attend:

Regulatory agencies, FDA or EPA, depend on documents and samples to evaluate the proper conduct of GLP studies in retrospect. Sponsors have a critical responsibility to retain records and samples completely, well-organized, secure, accessible for agency review, and protected from physical damage.

Areas Covered in the Seminar:
- Archiving practices that enhance the on-site review process conducted by regulatory agencies.
- The role and responsibilities of the archive and archivist.
- Organizational structure of archives.
- Physical protection of records.
- Tips for improving archiving operations and things to avoid.
- Example of an archive facility in a perfect world.
- In-house vs. out-sourced archiving.

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