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Good Documentation Practices for GXPs

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This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.

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

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:

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:

Who Will Benefit:

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

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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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 only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 60 Min
$349.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$499.00 Get Training CD Only
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