Good Documentation Practices for GXPs


Instructor: Anne E Maczulak
Product ID: 701320
Training Level: Advanced

  • Duration: 60 Min
This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.
Last Recorded Date: Apr-2012


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Why Should You Attend:

The FDA continues to cite documentation errors and omissions as one of its main findings during investigations. These errors take either of two forms:

  • Continual and repeated "small" documentation errors.
  • Critical documentation errors that affect the integrity of the study or batch records.

This presentation will review the requirements for documenting data in preclinical and clinical studies and manufacturing activities. It additionally covers the principle of data chain-of-custody. The presentation also covers traceability of samples, specimens, retains, discards, and archived materials.

Areas Covered in the Seminar:
  • The documentation practices that enhance study integrity, repeatability.
  • How to prevent 483 items related to data documentation.
  • The main documentation errors seen and cited by the FDA.
  • Why GLP serves as a good foundation for clinical studies, GMP, and even research.
  • Tips for documentation in lab notebooks.
  • Tips for documentation in synthesis research and feasibility studies not regulated by GLP.
  • A test for confirming documentation is complete and accurate.
  • A brief historical review of poor documentatiuon in the past before the advent of GMP and GLP.

Who Will Benefit:

This webinar is for the data-collecting and report-writing participants in all regulated companies:

  • Study directors
  • Management at sponsor companies
  • Principal investigators
  • Laboratory staff and analysts
  • Contract laboratories

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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