ComplianceOnline

Archiving GLP Records: How Archiving Makes or Breaks the Audit

Instructor: Anne E Maczulak
Product ID: 701505
Training Level: Basic to Intermediate
  • Duration: 60 Min

recorded version

$349.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

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.

Course "Archiving GLP Records: How Archiving Makes or Breaks the Audit" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

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.

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.
Who Will Benefit:
  • 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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Product Reviews Write review

This has been a great training course by Dr. MaczulaK! This training session was very appropriate for me since the FDA is at our facility today. I felt that we had a great handle on our records but feel even better now.
Thank you for sharing your knowledge with us today!!

- Anonymous

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