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.

recorded version

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
Last Recorded Date: Apr-2012

Training CD / USB Drive

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

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Fax: +1-650-362-2367


Read Frequently Asked Questions

Course "Good Documentation Practices for GXPs" 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:

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.

Follow us :
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FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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