Archiving GLP Records: How Archiving Makes or Breaks the Audit

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.

The speaker, a 20-year industry veteran, will review the importance of proper archiving and covers the options for managing large archiving facilities to small facilities with one-room archives. We will also review the practices currently in place at commercial archiving facilities. It presents tips on correcting mistakes that agencies have cited regarding archiving.

Attend this Webinar to improve on current archiving operations and to avoid common mistakes and misconceptions of the archiving process.

• 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.

• Sponsor company managers
• Sponsor company archivists
• Commercial archivists
• Study directors
• QA professionals

Instructor Profile:

Dr. Anne E. Maczulak , PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with large established companies as well as new startups that are in the initial stages of building a QA program. Her strength is in scientific writing, documentation, procedure manuals, and SOPs.

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